WO2017147652A1

WO2017147652A1 - Psycho-social methods and apparatus for: rehabilitation, pre-operatively and post-operatively to orthopaedic surgery

Info

Publication number: WO2017147652A1
Application number: PCT/AU2017/050176
Authority: WO
Inventors: Michael Nicholas; Kathryn NICHOLSON-PERRY; Toby NEWTON-JOHN; Catherine KETSIMUR; Myles Raphael James COOLICAN; Allan Richard MOLLOY; Gregory James Roger
Original assignee: Trifecta Brace Pty Limited
Priority date: 2016-02-29
Filing date: 2017-02-28
Publication date: 2017-09-08
Also published as: AU2017225905A1

Abstract

Psycho-social methods and apparatus for: rehabilitation as well as pre-operatively and post-operatively to orthopaedic surgery. The invention may identify the approximately 15-20% of total knee replacement patients that are likely to have a problem (e.g. pain, distress, lack of improvement in disability) post-surgery before they have surgery. In addition the invention may intervene pre-operatively and post-operatively to prevent or at least substantially reduce sub-optimal recovery outcomes. This invention provides a means for reducing post-operative complications, costs, complaints and / or re-admission to hospital.

Description

PSYCHO-SOCIAL METHODS AND APPARATUS

FOR: REHABILITATION, PRE-OPERATIVELY AND POST-OPERATTVELY TO ORTHOPAEDIC SURGERY.

BACKGROUND OF THE INVENTION

1. Field of the Invention

[0001] The present invention relates to orthopaedic devices and methods for use after orthopaedic surgery to joints and limbs. The present invention may also be applied in the treatment and rehabilitation of joints and limbs after injury with or without orthopaedic surgery.

2. Description of the Art

[0002] After an injury or orthopaedic surgery to a joint such as a knee or ankle it is common to apply a brace to the limb about the joint in order to provide support during healing. The brace may also restrict the movement or pivoting of the joint to one axis and to control or limit the angular range. The restriction of movement of the joint may be to aid with rehabilitation of the joint as well as in the case of orthopaedic surgery maintaining a desired alignment of the joint and associated structures and / or limb during the healing process. Examples of braces are those manufactured and supplied by such orthopaedic manufacturers as Bedsloe Brace Systems USA (www.bedsloebrace.com), Aircast walking boots as supplied by Don Joy Orthopaedics USA (www.dj oglobal . com and www.djortho.com) and Kendall Prosthetics and Orthotics USA (www.kendallprosthetics.com).

[0003] A consequence of orthopaedic surgery, as well as injuries to joints and limbs, is the consequent loss or reduction in mobility of the patient for several days to many weeks. The lack of mobility of the patient may put them at substantial risk of deep venous thrombosis (DVT) and venous-thrombo-embolic events (VTE), or in common terms a blood clot in one or more veins of the immobilised limb and complications associated with this. A possible consequence of DVT is a life threatening or fatal pulmonary embolism: that is a blockage of one or more blood vessels of the lungs possibly leading to respiratory failure and heart failure. Another possible consequence is post-thrombotic syndrome of the legs, which is associated with approximately half of the patients who suffer from DVT or a pulmonary embolism. Post-thrombotic syndrome of the legs is characterised by chronic venous insufficiency in the leg, such that the venous blood flow returning blood to the heart from the legs is insufficient causing venous pooling and hypertension.

[0004] There have been a number of studies of post-thrombotic syndrome. In a prospective study of 355 consecutive patients with symptomatic DVT, all of whom were instructed to wear graduated compression stockings for 2 years, Prandoni and associates observed a cumulative incidence of classic post-thrombotic syndrome of 17% after 1 year, 23% after 2 years, 28% after 5 years, and 29% after 8 years of follow-up. The cumulative incidence of severe post-thrombotic syndrome was 3% after 1 year and 9% after 5 years. Recurrent ipsilateral DVT during follow-up was associated with a 6-fold increase in the risk of developing post-thrombotic syndrome. The Prandoni study was published as Prandoni P, Lensing AW A, Cogo A, et al, "The long-term clinical course of acute deep venous thrombosis " Ann Intern Med. 1996; 125: 1-7.

[0005] In a further study by Haas it was reported that: "Post-thrombotic syndrome has been estimated to occur within 5 years in 60%-70% of patients who develop a proximal DVT, and within 2 years in 16% of patients who develop a distal DVT." Haas' study was published as "Review Deep vein thrombosis: beyond the operating table " Haas S, Orthopedics, 2000 Jun; 23(6 Suppl):s629-32. Ashrani also reported that "Post-thrombotic syndrome (PTS) can affect 23-60% of patients in the two years following DVT of the leg; of those, 10% may go on to develop severe PTS, involving venous ulcers". The study by Ashrani was published as Ashrani AA, Heit JA, "Incidence and cost burden of post-thrombotic syndrome " J Thromb

Thrombolysis 2009; 28: 465-76.

[0006] Orthopaedic surgery to the legs may also temporarily obstruct the major femoral and popliteal veins as a result of manipulations of the leg during surgery and the application of arterial tourniquets. In addition the physiology of the venous system in the vicinity of the surgery may be disturbed or altered for at least some weeks postoperatively. The disturbance of the venous system during and after surgery may also increase the risk of DVT and VTE.

[0007] It is therefore routine clinical practice that treatments to mitigate the likelihood of DVT and VTE are applied after orthopaedic surgery. However these treatments are still evolving to best clinical practice, for example as per the recommendations of the American Academy of Orthopaedic Surgeons (AAOS), "Preventing Venous Thromboembolic Disease in Patients Undergoing Elective Hip and Knee Arthroplasty: Evidence-Based Guideline and Evidence Report. " as published by AAOS 2011, USA.

[0008] Typically it is recommended that an intravenous, oral or subcutaneous anticoagulants and/or mechanical compressive devices such as intermittent pneumatic compression (IPC) and compression stockings be applied as preventative therapies to DVT and VTE. A regime of subcutaneous low molecular weight heparin (LMWH) over several days after orthopaedic surgery as a pharmacological prophylaxis is one common preventative treatment regimen. However the use of such anticoagulants may unacceptably increase the risk of bleeding and swelling at and about the surgical site with a consequent delay in the healing process and other complications; and furthermore may be contraindicated in those patients with increased bleeding risk..

[0009] A study by Colwell to compare use of anticoagulant versus compression prophylaxis. It was reported that: "Four hundred and ten patients (414 hips) were randomized; 392 of these patients (395 of the hips) were evaluable with regard to the safety of the intervention and 386 patients (389 hips) were evaluable with regard to its efficacy. Demographics were similar clinically between the groups. The rate of major bleeding events was 0% in the compression group and 6% in the low-molecular-weight heparin group. When compared with low-molecular-weight heparin, the use of the mobile compression device for prophylaxis against venous thromboembolic events following total hip arthroplasty resulted in a significant decrease in major bleeding events." The study was published as: Colwell CW Jr, Froimson MI, Mont MA, Ritter MA, Trousdale RT, Buehler KC, Spitzer A,

Donaldson TK, Padgett DE: "Thrombosis prevention after total hip arthroplasty: a prospective, randomized trial comparing a mobile compression device with low- molecular-weight heparin " J Bone Joint Surg. Am 2010, 92:527-535. [0010] Current best clinical practice recommends that dual prophylaxis with an antithrombotic agent and an IPC device during the hospital stay and that prophylaxis be continued for at least 10-14 days and preferably up to 35 days after surgery. In patients with an increased risk of surgery an IPC device is recommended rather than pharmacologic treatment.

[0011] Mechanical compression devices such as IPC may be applied to the limbs about a joint to increase venous flow, particularly blood flow in the deep, major veins of a limb. The increase in deep vein flow may substantially decrease the likelihood of thrombosis (formation of blood clots). IPC typically involves the use of a gas inflatable multi-chambered cuff about the limb to sequentially apply a circumferential mechanical compression about and up the limb towards the heart.

[0012] The sequential, intermittent application of bands of compression up the limb has the effect of compressing the deep and superficial veins and consequently forcing sequential venous emptying towards the heart. Sequential compression devices (SCD) are one of the most commonly used IPC devices. IPC devices and techniques have been the subject of numerous patents over many decades with the basic technique being well established. For example: US 4,013,069 (Hasty) to multi- chambered sequential compression, US 5,496,262 (Johnson) to static compression with foam inserts and a rigid outer shell, US 5,588,955 (Johnson) to partial cuffs to the limb, US 5,354,260 (Cook) to compression of the foot and US 4,091,804 (Hasty), US 5,876,359 (Bock) to a ventilation mode for cooling the limb with vents from the cuff.

[0013] It is also recommended for IPC mechanical compression that 18 hours per day of IPC be the compliance target. For current clinical practice guidelines, reference is made to the American College of Chest Physicians (ACCP) 2012 guidelines of: Yngve Falck-Ytter, Charles Francis, Norman Johanson et al,

"Prevention of VTE in Orthopedic Surgery Patients, Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: Evidence-Based Clinical Practice Guidelines. ", as published as the journal Chest 2012 February; 141(2 Suppl): e278S-e325S. A review article to consensus between the AAOS 2011 (see above reference) and ACCP 2012 clinical practice guidelines is given in Barrack, R L. "Current guidelines for total joint VTE prophylaxis: dawn of a new day. " [Review] Journal of Bone & Joint Surgery - British, Vol. 94-B, Suppl. A, pages 3-7, November 2012. [0014] Compression stockings and the like which alternatively to IPC apply a static or slowly varying mechanical compression to the limb appear to only be effective in preventing distension of the superficial veins. Other devices which may apply a static compression to an injury site or joint, such as PCT patent application "Temperature Regulated Compression Brace " published as WO 2007/014242 Al, may increase the risk of DVT or VTE since the static application of pressure to a localised area of the limb may reduce venous flow in that area.

[0015] Despite IPC being a well-established mechanical compression technique the clinical success of IPC is often affected by inadequate wrapping of the IPC cuff about the limb such that insufficient compression of the deep veins occurs. Contributing factors to this are the physiological variations in the circumferences in patient limbs as well the necessary, different static compression of the wrap required for different patients such as geriatric, obese, athletic and juvenile for example. In addition the IPC cuff is typically only applied when the patient is resting in a bed or chair, not when the patient is mobile. In addition, prior art braces for major orthopaedic surgery cannot be worn whilst prior art mechanical compression IPC is being applied to the limb. IPC is typically applied when the patient is not moving about as this is when pumping of the deep veins by the muscles in the affected limb is not occurring. When the patient is moving about a brace may be applied for support however it is traditionally accepted that IPC is not required at the same time since venous pumping by muscle contractions with limb movement may be sufficient. As a result the IPC cuff and the brace may be separately applied and removed several times a day by different staff with varying levels of experience and success.

[0016] It is noteworthy that when orthopaedic surgery has been performed on one limb such as a leg, for example to a knee joint or a femoral or tibial osteotomy, the other unaffected leg may have an IPC device applied to it more or less

continuously in order to prevent DVT and VTE. In the case of the femoral or tibial osteotomy the unaffected leg may have IPC applied to it for the first four to five days after surgery to the other leg. However the limb that has had the orthopaedic surgery typically will require a brace as part of the post-operative treatment. Available IPC devices cannot be used with available braces; or the brace and the IPC device are not compatible for fitting to the limb at the same time. [0017] Ritsema conducted a study to the factors affecting the use of SCD- IPC. It was found that: "Patient self-reported bother with SCD devices was low.

Hospital factors, including SCD machine availability and timely restarting of devices by nursing staff when a patient returns to bed, played a greater role in SCD noncompliance than patient factors." It was concluded that: "Identifying and addressing hospital related causes for poor SCD compliance may improve postoperative urologic patient safety." The Ritsema study was published as: David F Ritsema, Jennifer M Watson, Amanda P Stiteler and Mike M Nguyen, "Sequential compression devices in postoperative urologic patients: an observational trial and survey study on the influence of patient and hospital factors on compliance " BMC Urology 2013, 13 :20 /1471-2490-13-20.

[0018] In another study by Elpern it was reported that: "Nine hundred sixty- six observations were made of 108 patients, 47 (44%) of whom were ordered to receive thromboprophylaxis with IPC devices alone and 61 (56%) to receive IPC devices in combination with an anticoagulant. Errors in IPC device application were found in 477 (49%) of the observations. Patients received no IPC prophylaxis in 142 (15%)) of total observations. In 45 of 342 (13%>) of the observations, IPC devices were the only type of thromboprophylaxis ordered. Half of the misapplications related to improper placement of sleeves to legs. Misapplications did not differ in type or frequency between shifts of hospital staff." It was concluded that: "The researchers observed frequent misapplications of ordered IPC devices." In addition: "Future study is necessary to illuminate the consequences of such errors." The study was published as: Elpern E, Killeen K, Patel G, Senecal PA., "The application of intermittent pneumatic compression devices for thromboprophylaxis: AN observational study found frequent errors in the application of these mechanical devices in ICUs ", American Journal of Nursing, 113(4):30-6; quiz 37, 2013 Apr.

[0019] After orthopaedic surgery or an injury to a joint or a limb it is common to apply separately cooling or cryo-therapy to reduce pain and swelling. Cooling therapy may also reduce the likelihood of secondary hypoxic injury

(inadequate oxygen supply to tissues at the cellular level) which may further delay or impair the healing of the affected tissues. Secondary hypoxic injury is associated with: haemorrhaging from damaged blood vessels; hemostasis from the clotting cascade; reduced blood flow from the inflammation-induced increase in blood viscosity;

periods of ischemia from increased extravascular pressure from an expanding hematoma and/or a muscle spasm; hydropic swelling of cells after membrane damage which is capable of occluding vasculature.

[0020] In clinical practice cooling or cryo-therapy may be applied by the use of cold packs, sleeves or cuffs to the affected area of the joint and the associated limb. Chilled liquids such as water and crushed ice are commonly used in cooling and cryotherapy. In addition the use of cold sleeves and cuffs may also include static compression of the limb. An example of cooling and cryo-therapy devices is the product range of Aircast as supplied by Don Joy Orthopaedics USA

(www.djoglobal.com and www.diortho.com).

[0021] In clinical (inpatient and outpatient) and home care practice the application of each of the above three therapies of bracing, IPC and cooling and associated devices for each of them is done separately. Often the applications of the therapies are by different clinical or nursing staff with highly variable levels of experience.

[0022] In addition the success of these therapies as well as the speed and ease of patient recovery depends on the availability of three separate sets of equipment (IPC, brace and cryotherapy) together with the appropriately trained person to apply them when required by the prescribed treatment protocols. In the latter stage of home care a patient may apply these therapies and devices themselves, but may still be faced in their reduced mobility state by the not inconsequential logistics of applying two or three separate therapies and their associated equipment in the home environment. Often only two therapies may be applied at home, the brace and some cryotherapy. Additionally there is an increasing emphasis to patients being discharged early from hospital and minimising post-operative care staff in order to manage healthcare costs. It is generally known in clinical practice that the lack of compliance with a treatment / therapy protocol is a significant factor in delaying recovery of a patient and returning the patient to being a functioning and productive member of society. [0023] Rapid recovery protocols with early discharge from hospital for hip and knee orthopaedic surgery is increasing in Europe and the USA. Studies to this have been published as Hartog et al, Acta Orthopaedica 2013; 84 (5): 444-447 and Malviya et al, Acta Orthopaedica 2011; 82(5): 577-581. However patient anxiety to early discharge is often still present (Malviya-2011 as referenced herein) despite the criteria for early discharge being a functional one with adequate pain relief. For example early discharge criteria may include: walk 30 metres with crutches, ascend stairs in the home environment, dress and toilet independently and oral medication only for pain relief (Hartog-2013 as referenced herein). In addition patient compliance and clinical staff follow-up to those patients who proceed directly to home rather than a rehabilitation facility or whom may also discharge earlier from a rehabilitation facility may also be problematic.

[0024] There is a general lack of definitive guidelines to satisfactory patient progress with respect movement and in particular to different patient groups such as according to age, weight, prior activity level, occupation and type of orthopaedic surgery.

[0025] It has been shown that musculoskeletal conditions are the second greatest cause of disability across most regions of the world as measured by years lived with disability (YLD). Amongst the musculoskeletal conditions, osteoarthritis of the knees and the hips is third in YLD to lower back pain and neck pain. Osteoarthritis is a common precursor to major orthopaedic surgery. Reference is made to the following for the YLD report: "Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010 ", the Lancet, Vol. 380 December 15/22/29, 2012.

[0026] None of these prior art methods and devices provides an entirely satisfactory solution to the provision of post-operative care after orthopaedic surgery or aiding rehabilitation after an injury to a limb or a joint, nor to the ease of patient access to treatment.

[0027] Any reference herein to known prior art does not, unless the contrary indication appears, constitute an admission that such prior art is commonly known by those skilled in the art to which the invention relates, at the priority date of this application.

SUMMARY OF THE INVENTION

[0028] The present invention aims to provide an alternative arrangement, apparatus and methods which overcomes or ameliorates the disadvantages of the prior art, or at least provides a useful choice.

[0029] In one example form, the invention provides a method for treating a joint of a patient, including the steps: providing to the patient at least one of a validated psychosocial questionnaire, an OMPSQ questionnaire, a PSEQ

questionnaire and a Pain Catastrophising Scale questionnaire; analysing the questionnaire; detecting patient movement; analysing the patient movement to determine whether the patient movement is beyond a set parameters for each specific exercise; and analysing self efficacy from questionnaire and / or patient movement; wherein the set of parameters may be a plurality of performance indicators as described herein for the patient and a patient population for normative data.

[0030] The method further including the steps: providing a pacing schedule variation to the patient and obtaining feedback from the wearable device and the patient report on pacing schedule variation from a patient; analysing a number of pacing schedule requests with respect to at least one of a day, an exercise and a patient movement; determining a pacing schedule variation; and monitoring and education to avoid "underdoing " and "overdoing" of activity.

[0031] The method further including the steps: providing an intervention to a patient rehabilitation on the basis of at least one a questionnaire analysis, a patient movement analysis, a self efficacy analysis and a pacing schedule analysis.

[0032] The patient self efficacy is improved by at least one of: increasing patient satisfaction and adaptive / tailored exercise programs.

[0033] The method further including the steps: adapting at least one of an pacing schedule, an exercise, a ROM, an analgesia, an applied relaxation technique and the use of problem solving and pain management strategies for an intervention.

[0034] The method further including the steps: patients undergoes a combination of activity upgrading and instruction on active pain management strategies; and patient undergoes principles of cognitive behavioural therapy as part of "pre-habilitation" phase; whereby the patient experiences a better outcome after total knee replacement than those who have just exercises alone as part of a prior art rehabilitation or do not have a period of "prehabilitation".

[0035] The method further including the steps: patient undergoes a "prehabilitation" phase, including online instruction on active pain management strategies, wherein the patient significantly improves function despite planning to postpone their knee replacement surgery, in comparison to conservative, prior art management techniques.

[0036] The method further including patients who have a knee injury make significantly faster progress if they fully commit to and /or adhere to the method of the invention, the "re.cov.ery" program.

[0037] The method further including the steps of: prioritising an appointment for a patient; providing a secure video link between at least two of: a patient, a surgeon and a healthcare professional; and liaising directly with the patient by at least one of the surgeon and the healthcare professional; whereby a rehabilitation or recovery progression problem with the patient is reviewed by the surgeon and / or healthcare professional.

[0038] The method for treatment of respective joints of a plurality of patients, including: communicating a plurality of performance indicators from a plurality of patients to a data analysis centre; communicating a plurality of

corresponding performance targets to the plurality of performance indicators to the data analysis centre; communicating a plurality of de-identified and / or encrypted patient personal data to the data analysis centre; and analysing the plurality of performance indicators, the plurality of performance targets and the plurality of patient personal data to derive respective normative values to at least one of a patient type and a respective patient; wherein the respective normative data is provided to a respective clinician for a respective patient for at least one of determining and approving at least one revised performance target for the respective patient.

[0039] The method further including the step: providing patient adaptive exercise programs depending on the historical data, and the normative data. [0040] The patient personal data includes one or more of personal patient identifying data, a patient self-reported indicator, a pain report, a depression report or score, self-report measures of mood, function, disability, sleep, catastrophising, fear- avoidance, adjustment, injustice and quality of life; and a clinical staff reported indicator, including: sleep periods.

[0041] The analysis further includes analysing the patient personal data to classify the patient into a patient type for reference to a normative data set.

[0042] The plurality of performance indicators includes at least one of a number of steps, a gait, a period lying down, an ambulatory period, a range of motion of the joint, range of movement distance travelled, walking speed, stairs climbed, compliance with prescribed exercise regime for the plurality of patients.

[0043] The method further including communicating the at least one revised performance target to the respective patient.

[0044] The analysis further includes: analysing the at least one diagnostic indicator with respect to a patient personal data, a normative value, a patient type, normative value to a period from the surgical procedure, a normative value to at least one performance indicator; and determining the revised performance target.

[0045] The method further including an approval for a rapid recovery treatment protocol in response to the analysis.

[0046] The sensing further includes communicating the performance indicator to at least one of a clinical staff, the patient, a hospital and a data repository.

[0047] The method further including at least one of: providing visual of verbal feedback, encouragement, strategies to work towards achieving target and positive recognition, and encouraging patients to recognising and reward their achievements.

[0048] The revising of the performance target further includes: initiating clinical review of pain control or use of psychological coping strategies.

[0049] The method further including communicating at least one of a patient self-reported indicator and a clinical staff reported indicator to at least one of a clinical staff, a hospital and a data repository.

[0050] The sensing of the performance indicator includes sensing at least one of a number of steps, a gait, a period lying down, a posture, an ambulatory period, a range of motion of the joint, an acceleration, an orientation, stairs climbed, distance walked and pain score at rest and an activity.

[0051] The analysing further includes at least one of a normative data for the performance indicator, patient self-reported indicator and the clinical staff reported indicator.

[0052] The analysing further includes classifying the patient to a patient type from analysing at least one of the patient personal data.

[0053] The revising of the performance target includes at least one of a clinical staff analysing the performance indicator, corresponding normative data communicated to the clinical staff, the performance target, the patient self-reported indicator, the clinical staff reported indicator to determine the revised performance target and exploring reasons if performance target not met.

[0054] The method further including communicating the diagnostic indicator to at least one of a clinical staff, a hospital and a data repository.

[0055] The method further including analysing the diagnostic indicator with respect to at least one of a diagnostic indicator target, a normative data for the diagnostic indicator, patient self-reported indicator and the clinical staff reported indicator.

[0056] The method further including an approval for a rapid recovery treatment protocol in response to the analysis.

[0057] The method wherein an associated structure to the joint includes at least one of a portion of a limb attached to the joint, a limb including the joint, a leg, a thigh, a femur, a calf, a tibia, an arm, a humerus, a ulna, a radius and a foot.

[0058] The treatment to at least one of the joint and the associated structure includes at least one of a post-operative treatment after an orthopaedic surgery and a rehabilitation.

[0059] The orthopaedic surgery is at least one of total knee replacement, arthroplasty, femoral osteotomy and tibial osteotomy, condyles of the knee, ligaments of the knee and patella, fractures in and about the knee joint.

[0060] The orthopaedic surgery includes surgery to at least one of the associated structures and joints of the ankle, arm, elbow, wrist, hip and shoulder. [0061] The method wherein a recovery time of the patient is reduced compared with a treatment without a revised performance target for the respective patient.

[0062] The reduction in recovery time is to at least one of: a movement of the joint, a load bearing of the joint, an inflammation of the joint, a pain of the joint and a mobility of the patient.

[0063] In an alternate form the invention provides a method of treating a joint substantially as described herein.

[0064] In a further form the invention provides a graphical user interface and /or method as substantially described with reference to Figures 45 to 53 and accompanying text.

[0065] In a further alternate form the invention provides a wearable motion sensor "DOTS" and /or orientation sensor apparatus and /or method as substantially described herein.

[0066] In a further form the invention provides an system according to any one of the preceding claims for treatment of a joint of a patient.

[0067] In a further form the invention provides an apparatus according to any one of the preceding claims for treatment of a joint of a patient.

[0068] The performance sensor measures at least one of a number of steps, a gait, a period lying down, an ambulatory period, a range of motion of the joint, an acceleration, an orientation, stairs climbed, distance walked and walking speed.

[0069] The apparatus further includes a graphical user interface to a patient's mobile computer device, wherein the GUI is used by the patient to self-report at least one of: a pain score at rest, pain score on activity, and administration of a medication.

DISCLOSURE OF THE INVENTION

BRIEF DESCRIPTION OF THE DRAWINGS

[0070] The description is made with reference to the accompanying drawings; of which:

[0071] FIGURE 1 is a schematic of a first flowchart to the invention. [0072] FIGURE 2 is a schematic of table to Pacing rules of FIGURE 1.

[0073] FIGURE 3 is a schematic of a second flowchart to the invention..

[0074] FIGURE 4 is a schematic of a third flowchart to the invention.

[0075] FIGURE 5 is a schematic is a chart to further details for the flowchart of FIGURE 4.

[0076] FIGURES 6 to 9 are enlarged schematics to portions of the flowchart of FIGURE 4 to show the text within in the flowchart of FIGURE 4 more clearly.

[0077] FIGURE 10 is a schematic of a GUI for an "app" or program interface of the invention that a provider / surgeon / healthcare professional

[0078] FIGURE 16 is a schematic diagram to the interactions between multiple patients, doctors and a central data repository and analysis centre (DRAC).

[0079] FIGURE 33 is a schematic flowchart showing an example to the utilisation of the data acquired from multiple patients using multiple wearable devices.

[0080] FIGURE 34 is a schematic flow chart to further and alternate details to the processing, analysis and derivation of normative values, performance targets and other decision making computing processes and tools for the clinician.

[0081] FIGURE 35 is a schematic flow chart example to steps or other movement for FIGURES 33 and 34.

[0082] FIGURES 45 to 53 area series of figures to screen shots of a graphical user interface and functionality of the invention.

[0083] In the figures the reference numerals are prefixed by the figure number. For example FIGURE 1 is the "100" series, FIGURE 2 is the "200" series and so on.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0084] Major orthopaedic surgery to the knee constitutes a large proportion of orthopaedic procedures. Kurtz has reported approximately 4 million knee operations are predicted annually by 2030 and presently over 600,000 knee

replacements are being performed annually in the USA. The Kurtz study was published as: Kurtz S, Ong K, Lau E, et al. "Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030 " J Bone Joint Surg Am 2007; 89: 780-5.

[0085] A large contributor to the need for knee surgery is osteoarthritis, where it is estimated that osteoarthritis of the knee affects approximately 250 million people worldwide, as published as The Lancet "Global Burden of Disease Study 2010 " 13 December 2013, www.thelancet.com/themed/global-burden-of-disease. Osteoarthritis of the knee accounts for 83% of the total osteoarthritis burden in the world. Injuries to the knee such as damage to the Anterior Cruciate Ligament (ACL) are also significant with about 100,000 ACL injuries in the USA per year as reported and published by the American Academy of Orthopaedic Surgeons (AAOS) USA as: Csintalan R.P., Inacio M.C.S., Funahashi T.T., "Incidence rate of anterior cruciate ligament reconstructions. " Perm J 2008: 12: 17-21 and Lyman S, Koulouvaris P, Sherman S, Do H, Mandl LA, Marx RG., "Epidemiology of anterior cruciate ligament reconstruction: trends, readmissions, and subsequent knee surgery. " J Bone Joint Surg Am 2009: 91 : 2321-2328.

[0086] Advanced osteoarthritis of the knee is often treated with a Total Knee Replacement (TKR) or a Total Knee Arthroplasty (TKA) where the osteoarthritic degraded bearing surfaces or articular cartilage surfaces of the knee joint are replaced with artificial surfaces. Where the osteoarthritis is less advanced a knee osteotomy may be performed to change the alignment of the knee joint bearing surfaces between the femur and tibia to areas of the bearing surfaces, which are less damaged. The application of an embodiment of the invention to knee osteotomy provides a useful first example of the invention for a major orthopaedic surgical procedure.

[0087] The invention/s may also be applied in the management of chronic osteoarthritis. For example a minimal brace with motion sensing or self-adhesive accelerometer patches or "dots" described below may be used to monitor the patient and provide communication and care management to a patient graphical user interface (GUI) as described below with respect to FIGURES 45 to 53 and elsewhere herein.

Data Logging and Information Transfer:

[0088] The wearable electronic device or "DOTS" described herein wearable device and / or control unit may have sensing transducers, amplifiers, instruments, computer processors and computer memories to data log and verify that various treatment protocols have been undertaken by the patient wearable device. For example the following may be prompted to the patient and recorded: range of movement exercises, walking,.

[0089] The data logging memory may be located upon or in the wearable device described herein or the control unit. Communication and information transfer between the wearable device and control unit may be via the a service connection line or a suitable wireless transmitter and receiver system such as Bluetooth and other short range antennae transmitting and receiving technologies to either the patient's mobile device or otherwise as described herein wearable device. Communication with the clinician is described in further detail with respect to FIGURE 16 and further.

[0090] The services connector from the wearable device to the control unit may also contain a re-writable memory device or equivalent integrated circuit (not shown). The memory device in the services connector line may allow the wearable device to identify itself and the patient to any control unit. The memory device may also be pre-loaded or programmed with the patient's prescribed therapy program with the wearable device so that any control unit in the ward or rehabilitation clinic or at home may be used by the patient with their wearable device without intervention by nursing or physiotherapy staff unless prompted by the memory device / wearable device or patient. This system will need to be suitable to function at home as an increasing number of patients are being treated with "Rapid Recovery Protocols" and are discharged on the same day as surgery or shortly afterwards in one to three days. The operation of the wearable device in this manner allows for patients using a wearable device to be transferred about the hospital or clinic without a dedicated control unit. It also has the advantage that the records and prescribed treatments for the patient with the wearable device are automatically transferred with the patient and the wearable device they are wearing.

[0091] When the patient is in the home recovery or out-patient phase their home control unit may be automatically updated with their new treatment protocols from their latest visit to a rehabilitation clinic or their orthopaedic surgeon. At the rehabilitation clinic the patient's compliance with treatments with the wearable device may be reviewed and revised for later uploading to the home control unit. In addition if compliance is low and the risk of DVT and VTE is high, alerts may be flagged at the rehabilitation clinic when the patient is visiting the clinic. Alternatively the home control unit may alert the clinic via a messaging service or an internet connection that a home visit by clinic staff may be required. Alternatively the patient may receive feedback from an analysis of the data gathered by the wearable device. For example, the feedback may be in the form of graphical and / or written report updates to the patient to their recovery progress and level of compliance with the treatment protocols. Such interactions are described in further detail below with respect to FIGURES 17 to 23 and 31 to 37.

[0092] FIGURE 16 is a schematic diagram of communications between a wearable device and a clinician. The wearable device may communicate 1620 directly with devices used by a clinician without the aid of the control unit. For example the clinician may have a handheld programmer unit, an iPhone, an android compatible cell / mobile telephone, wireless computer tablet, desk or laptop computer. The connection 1626 between the clinician's device 1622 and the wearable device or wearable device may be as described herein for the control unit and also include wireless connection to an internet modem or "hotspot" internet service provider or the patient's home internet modem. FIGURE 16 also shows optional communication and the transfer of data and instructions to and from a remote analysis, data gathering and/or advisory center 1624.

[0093] The wearable device and control unit may have sensing transducers, amplifiers, instruments, computer processors, accelerometers and computer memories, as described herein, to data-log and document adherence to the various treatment protocols which may be prescribed for the patient. This data may be electronically streamed to selected healthcare professionals and compared to normative data to provide advice to treatment as described herein. De-identified (of patient identifying details) data may also be collected by a data gathering and analysis center 1624 (FIGURE 16) or proxy (with appropriate consent by the patient) for meta-analysis and other more detailed analysis of de-identified and / or encrypted data. Alternatively the patient may use only an approved USB compatible memory device (or other removable such device) to facilitate data storage, data transfer and/or communication of instructions. For example the following data may be continuously or

intermittently recorded:

• Number of episodes of walking and resting.

• Number of steps, time taken and average speed / walking speed.

• Walking distance.

• Height climbed for example stairs.

• When and how long the patient is lying down. That is the orientation of the patient.

• Number of falls and alert/link via Wi-Fi/smartphone to a carer to alert them to an incident and / or alert an emergency aid service.

• Patient may also record on a cell / mobile telephone, tablet or computer their pain score (at rest and with activity), their well-being and / or depression score and their pain medication intake and complimentary treatments e.g. herbal supplements, acupuncture, which may then be sent electronically, FIGURE 16 to a clinician such as a health professional (surgeon/anaesthetist/pain specialist/ physician assistant, primary care doctor or nurse) to be evaluated for adjustment according to other data such as activity levels together with information supplied by and sent to the wearable device.

• wearable device

• Measurement of range of movement (ROM) of knee or other joint being treated.

• As described below with respect to FIGURES 45 to 53.

[0094] A pain management algorithm may also be incorporated into the software or firmware of the wearable device. The pain management algorithm may through biofeedback give written (via a patient's home computer for example) and verbal guidance (via a speaker on the wearable device or via a patient's home computer for example) on adjustments to graded activity according to the health professional's protocols to minimise under/overdoing therapy. This may be extended to incorporate basic pain management alerts such as rest, relaxation and cognitive challenging as described in "Manage your Pain" , Nicholas MK, Molloy AR et al (Harper Collins Books, ISBN 978 0 7333 3024 7 {paperback} and 978-0-7304-9765-3 {e-publication}. Published editions: 2000, 2006 & 2011), the contents of which are incorporated herein by reference. The pain management algorithm/s may be combined with bio-feedback devices incorporated within the wearable device to encourage patients to complete graded activities and avoid underdoing/overdoing therapy. It will be readily appreciated that such pain management algorithm and further adaptations of the wearable device may also result in the development of algorithms integrating measures of activity/ cooling/ pressure against outcomes of pain, range of motion, DVT, and as described herein.

[0095] It will be readily appreciated that other algorithms may also be used to analyse and report variations in measured parameters. The reporting may be to the clinician to aid in patient management for example to: corrective action required, over or under therapy protocols, on target to treatment protocols and the like.

[0096] Clinical trial data to a clinical trial for an orthopaedic procedure and/or other treatment procedure may also be gathered from a number of wearable devices or wearable devices. Such trial data may be collected automatically from each wearable device in use and sent to a central data register and analysis 1624 site. The data may then be used to analyse efficacy to a trial that the collection of wearable devices are being used for. The data collected may also be used for ongoing improvement in the use and product development of a wearable device product range. Further detail to data collection, processing, analysis and feedback is described below with respect to FIGURES 31 to 37.

Movement Sensing:

[0097] The wearable device applied to the knee may have a rotary encoder coupled to the pivot means in order to sense pivoting movement or may achieve this via other means as described herein. Application areas with more complex multi-axis movement such as shoulders and hips may require movement sensing that are based on a fibre-optic over the length of the limb and sections of the torso. Fibre-optic movement sensing technology has the particular advantage of being light weight and non-intrusive for the sensor length applied to the limb and torso. An example of a possibly useful fibre-optic technology for position and motion measurement is "ShapeTape" as supplied by Measurand Inc, Canada

(www.measurand.com/shapetape.htm).

[0098] Accelerometer sensors may also be applied to the wearable device to detect translational movement as well as to derive range of movement. For example such as walking where the wearable device is only sensing knee pivoting with a rotary encoder to the pivot means.

[0099] The wearable devic when used without a brace or support means to the patient, may use XYZ (tri -axial for example) accelerometers applied to the upper and lower limbs of the leg in order to derive range of motion data for the knee.

Similarly fibre-optic sensing techniques as described herein may also provide a wearable technology suited for providing range of motion measurements for the wearable device. Such use of multiple accelerometer sets and a fibre optic sensing techniques are examples of distributed or segmented sensing to the limb.

[00100] Another device that may also be used for the motion sensing, described with respect to FIGURE 53 and elsewhere herein, may consist only of motion sensing. For example accelerometer adhesive patches adhered to a patient's skin or clothing. The accelerometers or other suitable motion and / or position sensors may also be packaged in a "dot" packaging format similar in dimensions and weight to a coin or disc like battery. Such dot motion sensors may be incorporated in or adhered to gloves, stockings, straps, sleeves, shoes and the like where motion and / or position sensing is desired. It will be readily appreciated that a single sensor may be used for a linear motion, whilst two or more sensors may be used to provide other more complex translational or angular motion ranges for limbs and bodies. For example two accelerometer "dots" each applied to a thigh and a calf of the patient, synched together may then provide angular movement sensing for a patient's knee. The accelerometer "dots" may have their own compact power supply and

communicate wirelessly with each other and a control unit or patient mobile device as described herein.

[00101] In addition the accelerometer adhesive patches or "dots" or other compact motion sensing package may also include patient orientation sensing and analysis. Patient orientations include: lying down, sitting, standing and other useful orientations or patient postures for patient care management. The "dots" or otherwise compact sensor/s worn by the patient may also include a heart rate monitor and / or blood pressure monitor to aid in patient monitoring during exercise.

[00102] Gait analysis as well as leg versus leg analysis may also be done with the aid of accelerometer sensor sense and / or fibre-optic techniques. An example is for patients who have had bilateral knee replacements or a unilateral knee replacement where the other knee has significant functional impairment.

[00103] Orientation sensing of the patient to lying down, seating, reclining and erect walking may be done with one or more orientation sensors to the wearable device / liner or to a belt 2620 (FIGURE 24). The accelerometer sensing sets to the limb with the wearable device / brace may also be used in combination with an orientation sensor on the belt 2620 or upper limit to provide patient orientation sensing. Sensing of orientation of the patient may be used in the control of applied compression and cooling. For example when the patient is ambulatory compression is not required and the operation of cooling may be a distraction or hindrance. However when the patient is not mobile then sequential compression for venous flow may be highly advisable as well as cooling for swelling and pain relief. In addition the orientation detection between sitting or lying down may be used to control the pressure level of the sequential compression applied to the patient's limb. The orientation of the patient may be used to feedback to the pressure level setting and sequential time period settings for the compression chambers to what may be appropriate for the patient with respect to their orientation.

[00104] The data from various sensors for movement of the patient as described herein are examples of performance indicators of how the patient is performing in relation to desired or set performance targets to such things as movement compliance with a prescribed exercise regime, compliance with wearing the wearable device / brace and the like. For example number of steps per day to be taken and improved gait. An example of patient step goal setting and feedback is shown in FIGURE 19 and further herein. Control Unit:

[00105] A control unit may be connected with the wearable device as described above to supply services. The control unit may be portable and battery driven, suitable for the hospital, rehabilitation clinic and home environments.

[00106] The control unit may also supply support to the wearable device for the data logging, information transfer, data processing / analysis and sensing as described above. The control unit may also contain sensor amplifiers and signal processors in support of miniaturised and low power sensors that may be used by the wearable device as described above.. These functions of the control unit may alternatively be incorporated in a belt 2620 as described below with respect to

FIGURES 24 and 26 for the wearable device 2410.

[00107] The control unit may also be interactive with the clinical staff and patient. For example to providing audio or visual prompts to clinical staff and the patient that a treatment protocol is overdue or has been successfully completed.

Alternatively the wearable device may have a small loudspeaker to provide audio prompts, either under instruction from the control unit and / or from a computer processor also located upon the wearable device. Alternatively these communications to the patient may be via the control and support belt 2620 described below with respect to FIGURES 24 and 26. In yet another alternative such communications may be to the patient's hand held, mobile device as described with respect to FIGURES 16 to 19, 32 and 33 as well as elsewhere herein.

Other Application Areas:

[00108] The wearable device may also be re-configured and applied to other orthopaedic procedures to the knee joint and the associated structures of the femur and tibia. For example those associated with: total knee replacement, arthroplasty, femoral osteotomy and tibial osteotomy, osteotomy to the proximal tibia, condyles of the knee, ligaments of the knee and patella, fractures in and about the knee.

[00109] The invention may also be applied to applications where there has been orthopaedic surgery or an injury to the ankle and / or the associated structures of the ankle. In such an application a cast, brace or immobiliser boot or fitting may be applied to the leg from below the knee, encasing the ankle and extending to the foot. The wearable device may be applied to the ankle and associated structures for:

bracing, support, immobilisation, IPC and / or cryotherapy as required.

[00110] Other applications from major orthopaedic surgery are the limbs, joints and associated structures of the arm, elbow, wrist, hip and shoulder. For example the ball and socket joints of the shoulder and hip together with the respective associated structures of each limb as well as for example the scapula, clavicle and ilium. Similarly for a hinge joint of the elbow and associated structures of the forearm and humerus. Also for example the wrist joint and the associated structures with it.

[00111] As described above earlier, the invention may also be used during the recovery and rehabilitation phases after a sporting injury or other injury that does not require orthopaedic surgery or other surgery.

Further Advantages:

[00112] The use of the wearable devices and / or liners by patients who have undergone major orthopaedic surgery may allow for a significant reduction in the use of pharmacologic prophylaxis of DVT and VTE.

[00113] The combined and co-operative features of the wearable device and / or liners allow for the wearable device and wearable device to be worn substantially continuously by the patient. The wearable device may be worn at least 14 hours per day with a substantial portion of the wearing period including the application of sequential mechanical compression. Preferably the wearable device is worn such that at least 18 hours a day of sequential mechanical compression via the compression means is administered to the patient. More preferably the wearable device may be worn as long as possible within a day and / or a night period.

[00114] Patient compliance and a recovery time may be substantially improved with the wearable device as the three therapies of bracing, compression to reduce DVT and VTE with cooling therapy are applied with the one apparatus which remains with the patient during their recovery period. The improvement to recovery time may be with respect to: a movement of the joint, a load bearing of the joint, an inflammation of the joint, a pain of the joint, a mobility of the patient, reduced thrombosis, DVT and VTE. The wearable device may not be dependent to a particular control unit or require continuous connection with a control unit. This lack of dependence to a particular control unit significantly improves the portability of the wearable device with the patient. Other communication and storage protocols may also apply as described herein.

[00115] The integration of three therapy functions into the wearable device may allow the hospital inventory to reduce size ranges of individual items such as individual braces, individual IPC sleeves and cold therapy packs may be extensively reduced. The wearable device as a single item in a range of sizes need only be stocked. This may provide a saving in inventory complexity and storage space by factor of three or more.

[00116] The use of the wearable device may reduce healthcare costs by replacing three sets of therapy apparatus with one apparatus. In addition the components of the wearable device are readily adaptable to mass manufacturing where the wearable device is designed for single use disposability after some months of a single patient's use of it. In addition the advantages in the compression means to providing further fitting and securing means to the patient may allow for a reduced number of products to different size ranges. The potentially more expensive control unit is intended for repeated use in the hospital, rehabilitation clinic and home care environments. The improvements with patient recovery time with the wearable device may also reduce the in-patient time as well as the risk of complications. Furthermore the patient may be more rapidly returned to being a more productive member of society with an improved recovery time with the wearable device.

[00117] It will be readily appreciated that the wearable device may be supplied in kit form ready for assembly and use. Spare parts for the wearable device may also be readily supplied as desired and as described above.

[00118] The control unit may also be separated from the wearable device and used with range of wearable devices as described herein. In addition the control unit may instead be a number of sub units for separate or combined control of different aspects of the wearable device, as described herein.

[00119] It will be readily appreciated that many if not all aspects of the wearable device's design, construction, functioning, service provision and interaction with clinical staff may be readily adapted for elderly or geriatric patients. Adaptations for elderly or geriatric patients may include: reduced weight, more autonomous function, more alert functions which may also be set at lower or more sensitive thresholds, reduced functionality. One example may be the elimination of the use of any ice packs / pouches or pre-chilled water for pre-chilling or pre-cooling. Instead thermo-electric or Peltier cooling may be used more intensively for cooling with increased power demands to the thermo-electric cooling means.

[00120] Further advantages are described below with respect to FIGURES 14 to 37.

[00121] FIGURE 16 is a schematic diagram to the interactions between multiple patients 1620, doctors 1622 and a central data repository and analysis centre (DRAC) 1624, 1626. Mobile device software applications and computer programs as applied to cellular or mobile telephones and wireless tablet computers are often referred to as "apps" and will be referred to interchangeably within the detailed description herein. In addition to what was shown in FIGURE 16 the wearable device / brace may also communicate directly with the patient's mobile device 1720 or via the internet / cloud IP servers 1626.

[00122] The wearable device to each patient may acquire and communicate data that will inform the patient and doctors, preferably in real time, about how the patient is progressing with respect to expectations (generated normative values) or performance targets. For instance, if a certain level of exercise is prescribed for the patient then compliance and progress as performance indicators may be recorded and checked by clinical staff, who may then provide feedback as performance targets (for example) to the patient, as shown in FIGURES 20 to 22 and further in FIGURES 34 to 36. The performance indicators or performance targets for angular range of movement and number of daily steps are shown to right of the "dashboard" style GUI of FIGURES 20 to 22. As an of feedback to multiple aspects: if a patient is overdoing their exercises and consequently increasing their pain, automated or semi-automated feedback from the Doctor may be communicated to the patient to reduce their exercises, take more analgesia and / or contact their doctor for a face to face consultation. Automated feedback may be in the form of auto-prompts regarding the use of a range of strategies by the patient. In another example for range of motion exercises for a joint, these too may be monitored as recovery from surgery or injury progresses and new or revised performance targets displayed as rehabilitation progresses.

[00123] Patients may be able to access "comfort graphs" or progress charts of how they are progressing as compared to a matched cohort of normative values for their patient type. In addition the patient may be able to track their own rate of progress within their confidence limits. In FIGURE 19 the step data GUI 1920 displayed on the patient's mobile device may provide historical, performance information to the patient's daily number of steps, their goal or performance target for steps and a progressive total for the present day. The goal or performance target 1922 may be derived from the normative values supplied by the DRAC 1624 to the patient type. A display and control GUI 1924 may provide a diagnostic indicator 1926 to the temperature set for the cooling means and optionally limited patient control to vary the temperature. Similarly for sequential compression display and control to 1928 with a corresponding diagnostic indicator may be provided. Such patient requests for a variation in the amount or level of cooling and / or compression may be checked against thresholds set by the clinician and normative values (described further below). For example the period of cooling and amount of cooling applied to the limb will have safety limits and therapeutic limits. The period of compression may also be limited in order that the patient be encouraged to move and meet ambulatory performance targets.

[00124] Another GUI may provide another diagnostic indicator or diagnostic alert 1930 to the necessity to change the "ice battery" which provides the cold sink or cold pouch for the cooling means of the wearable device / brace. Yet another GUI may provide cooling and sequential compression reporting to whether the fit of the liners to the limb is right, pressure and cooling are satisfactory for the set limits for temperature and time (to clinician and patient). For example if the force / pressure sensors on the skin do not indicate a close fit to the limb by the multifunction liner then this can be alerted to the patient to re-adjust in the form of a "fitting" alert which may be as simple as a green or red indicator on their mobile device "app". Similarly extended non-compliance with not wearing the liner / stocking may be flagged to the clinician for follow-up. [00125] Other examples GUIs may be to: range of movement of a joint, exercise compliance and the like are described herein.

[00126] In addition other GUIs (not shown) may allow for self-reporting by the patient for such things as pain scores, the self administration of oral analgesia medications such as paracetamol, prescribed medications and the like. Self-reported patient personal data may then be communicated 1626 to clinical staff 1622 and / or the DRAC 1626. It will be readily appreciated that such patient personal data may be suitably de-identified and / or encrypted as is suitable for the method of transmission, use of the data and the applicable privacy laws for a country.

[00127] Certain patients have a low confidence to manage pain and may also be fear-avoidant: that is they are fearful that movement may cause damage or injury. If such patients' receive direct and authoritative feedback as performance indicators and performance targets that they are performing as expected then typically they tend to be more tolerant of less face time with doctor and self-manage their recovery better. Accordingly the Doctor may then have more time available to attend to patients that have progress reports which are progressing poorly, at risk or need intervention either in the out-patient or in-patient setting.

[00128] FIGURES 20 to 23 also illustrate a "dashboard" on a clinician's mobile device, such as a wireless connected tablet computer or mobile / cellular telephone, of all their patients. The analysed and processed information presented to the clinician may have performance indicators, diagnostic indicators and alerts of who needs to be: assessed urgently, encouraged or only briefly engaged with; thereby prioritising ward round time for in-patients and out-patient follow-up. It will be readily appreciated that additional sources of information, such as blood counts, from hospital pathology laboratories and the like may be also retrieved / uploaded, analysed and displayed on clinician's mobile device to assist in prioritising patients.

[00129] In FIGURES 21 and 22 direct reporting to the diagnostic data to the operation of the compression 2122 and cooling 2124 liner may be made available to the clinical staff to assess satisfactory or otherwise operation and use of the wearable device. Additional temperature sensors to the skin may also report to the clinician as an early diagnostic indicator of the onset of infection as well as other pressure and force sensors as other diagnostic indicators as described herein. [00130] In addition to the local use of data between the patient and the doctor, the data acquired, feedback and the like may for multiple patients and doctors be centrally collected, processed and analysed at a data repository and analysis centre 1624. For example processing and analysis may be done to refinement of treatment modalities after orthopaedic surgery, wearable device operational parameters , derivation of early indicators of adverse events such as infection, stiffness, gait abnormalities and weakness to such activities as stair climbing, and leg versus leg comparisons. In another example the wearable device reported diagnostic and performance indicators / data correlated to patient medication may provide improved treatment protocols: patients on low dose aspirin or even warfarin anticoagulant / blood thinning therapies may need to have the brace cooler and snugger. Similarly, after taking paracetamol the level and period of cooling by the cooling means may need to be reduced for two to four hours. Conversely, increased cooling may reduce the need for analgesia. The processing and analysis may then be used to generate normative values for particular patient types or cohorts. Such centralised collection and processing is described below with respect to FIGURES 34 to 36 and elsewhere herein.

[00131] From such meta-data outcome analysis opportunities to demonstrate improved outcomes and lower revision/failure rates for certain treatment modalities may be readily obtained. In another example implant specific findings may be made which is specific to implant brand, design, material and implantation technique. For instance a cement-less knee replacement through a lateral approach may need more frequent compression and more cooling than for a medial approach or cemented (due to more bleeding). The wearable device with centralised collection, processing and analysis allows such meta-analysis of past treatments to be readily done, whereas traditional prior art data gathering techniques are expensive in terms of time, staff resources and the medical expenditure budgets.

[00132] Further details to the interactions, processes and analyses between the patient, clinical staff and other centralised functions are described below with respect to FIGURES 34 to 36. Further apparatus and processes for performing the invention for a patient are described further with respect to FIGURES 24 to 33. [00133] FIGURES 24 to 30 are schematic diagrams to a wearable device 2410, 2910 that may not have a brace or support means. As described earlier some orthopaedic surgeries and injuries for rehabilitation may not require a brace support or only a minimal support means.

[00134] FIGURE 24 is a perspective view of a wearable device 2410 wrapped about the thigh 422 and calf 528 of the patient. In contrast to FIGURES 5 and 11 the wearable device 2410 does not feature a brace or support means. The wearable device 2410 may wrap about the limb in a cuff like manner and as described elsewhere herein. Alternatively the liner may be in the form of one or more stockings or sleeves. The stockings may have the inflatable chambers incorporated into an elastic fabric or textile stocking such as Lycra, Spandex or elastane. Such versions of the multifunctional liner may be particularly attractive for continuous wearing during the first few days to weeks after orthopaedic surgery and / or during rehabilitation after injury. An unobtrusive and easily worn wearable device 2410 may form what is commonly termed "wearable technologies" where in order to be worn continuously or for large portions of the day and night, comfort and not obtrusive is very important.

[00135] The wearable device may incorporate both the compression means and cooling means within the one liner or may be made up of a separate liner for each of the compression means and cooling means. For the separate liners one may be wrapped above the other. The other forms of the wearable device may be as described for the compression and cooling means described herein elsewhere. The combination of the cooling liner component innermost against skin with compression liner component around the cooling liner may allow for the pressure from the compression liner to give better contact for cryotherapy. A static pressure may be applied to the compression liner's inflatable bladders or cuffs in order to provide uniform, thermal contact of the cooling liner to the limb.

[00136] The wearable device may when inflated or otherwise pressurised for use, either for compression and / or cooling may also form a brace or support for the limb and joint.

[00137] The wearable device 2410 may have a service connection trunk line 2450 as described with respect to FIGURES 5 and 11 and further here. The service connection trunk line 2450 may connect or otherwise be wirelessly interfaced to a control and support belt 2620, described with respect to FIGURE 25.

[00138] In addition to the sensing associated with the wearable device 2410 itself an oxygen saturation sensor 2452 as an anklet or other suitable position on the limb, associated with the liner, may be used to measure the oxygen content in tbe blood. The oxygen saturation sensor may be in the form of a pulse oximeter or similar device as selected by a person skilled in the art. The oxygen saturation sensor 2452 may be interfaced to the service connection line 2450 and / or the control and support belt 2620.

[00139] A low oxygen content may provide an early indicator to the likelihood of a pulmonary embolism. In particular when the diagnostic indicator data from the oxygen saturation sensor 2452 is combined with performance indicators to the lack of movement history for the patient and health prior to and after surgery. An early alert derived from an oxygen saturation diagnostic indicator and one or more mobility performance indicators may enable a prompt follow-up alert to be acted upon for such patients before they deteriorate into a life threatening situation, as described further below.

[00140] FIGURE 26 is a perspective view of the optional control and support belt 2620 that may be worn by the patient or used at a distance with wireless interfacing. The belt may incorporate an appropriate antenna with a transmitter and a receiver 2622 for wireless communications 1626 to the clinical staff 1622 and DRAC 1624. The belt 2620 may include a central processing unit 2624 (CPU) and memory 2626 for local data acquisition, processing, analysis, feedback control as described herein.

[00141] FIGURE 33 is a schematic flowchart showing an example to the utilisation of the data acquired from multiple patients using multiple wearable devices / braces 3320. Data acquired or used by the multiple electronic wearable devices or "DOTS" device in use is transferred to a DRAC 1624. The data acquired or used may be the performance indicators, performance targets, diagnostic indicators and other data described herein. In addition suitably de-identified and / or encrypted patient personal data may also be supplied to the DRAC 1624. [00142] Personal patient data may include patient self-reported information prior to surgery and post operatively. Prior surgery or prior to the injury or pre- rehabilitation (also termed "prehabilitation" in the following description) the information supplied by the patient may include the patient's age, weight, activity and fitness level, health history, occupation, musculature to fat ratios, mood, function, disability, sleep, catastrophising, fear-avoidance, adjustment, injustice and quality of life and the like. In addition the patient may be administered a questionnaire to quantify the above and a depression or well-being measures such as a depression score. The questionnaire may be supplied to the patient in the form of a GUI pick list as shown for other examples in FIGURES 45 to 53 below. The patient prior to surgery or pre-rehabilitation may also wear or use the accelerometer "dot" motion sensors, described elsewhere herein, in order to provide baseline activity levels for the patient. Such baseline activity levels may be automatically acquired and/or manually entered by the patient.

[00143] The invention may also be used to analyse, diagnose and provide assessment to patients on the basis of their psychological profile and a pick-list questionnaire. For example via the processes described below with respect to

FIGURES 33 to 35. Patients who may score in the clinically significant range on any of the psychological measures such as depression, anxiety, fear, catastrophising, etc. may by the diagnostic suggestions of the invention, with the clinician, be offered a review with a clinical psychologist or a psychiatrist to determine if a more intensive pre-surgery "prehabilitation" treatment program may be needed. One outcome from such a psychological assessment may be a recommendation that surgery be delayed until the patient is deemed ready by the psychologist or psychiatrist to participate in the surgery and the necessary post-operative rehabilitation.

[00144] Post-operative information that the patient may self report may include: pain scores, the amount and type of self-administered oral analgesia, updates to the information provided pre-surgery and the like. Clinical staff reports may include: the type of surgery undertaken / type of injury and complications arising during surgery or afterwards. In addition nurse's reports to in-patients may be included to: respiratory signs, pulse / heart rate, oxygen saturation, temperature, blood pressure, pathology results, sleep periods and the like. Physiotherapy clinical staff may also supply reporting to physiotherapy attempted and successfully completed, in addition to that reported by the performance indicators of the wearable device / liner.

[00145] The patient personal data may be used to classify a patient into one of a number of patient types for the purposes of processing and deriving 3322 normative values 3324 from the data acquired from the plurality of wearable devices 3320. The normative values 3324 for a patient type may then be communicated to the Doctor or clinical staff 3326, 3328 responsible for each patient 3320. In addition further processing may be done to derive from the relevant normative values 3324 to obtain patient performance targets for consideration by the relevant Doctor or clinical staff 3326, 3328. The further processing may include relative trends in order to set performance targets or goals that vary relatively from day to day by say +10 to +20% as an example. Alternatively some performance targets may be set and adjusted in absolute terms, for example a range of angular movement of the knee may need to attain a certain angle range by a particular day from surgery. The Doctor may then consider, revise and / or approve these performance targets and communicate them to the relevant patient directly. The normative values 3324 for a patient 3320 may also be communicated directly to the patient to provide "comfort graphs", and the like as described herein, to provide a comparison between their actual performance and satisfactory normative values for their patient type. In addition the Doctor 3326, 3328 may also directly communicate with the data repository 1624 for clinical staff reported data, indicators and decision making.

[00146] The normative values 3324 may also be communicated to a local hospital or medical region administration 3330 where the relevant patient 3320 is an in-patient or out-patient. The local hospital 3330 may use the normative values 3324 for the patient together with the patient progress reports from the DRAC 1624 to assess how the patient is complying with recovery protocols as an in-patient, discharge criteria and as an out-patient. In particular the local hospital processor 3330 may evaluate whether extra follow-up for a patient 3320 is required or preparation for re-admission may be necessary. In one example a hospital computer processor 3330 may evaluate whether a patient is complying with "rapid recovery" protocols for early discharge and derive specific additional guidelines 3332 for that medical region and patient to be communicated for the Doctor 3326, 3328 and associated clinical staff responsible for a particular patient's care.

[00147] In addition to the data being processed and analysed for direct patient care, further processing and meta-analysis 3334 may be done to derive proposed adjusted or new clinical treatment protocols. Furthermore these adjusted or new clinical treatment protocols may be used to evaluate 3336 initial and ongoing approvals from a health insurer provider and government national health insurer for the patient and Doctor, wearable device

[00148] The adjusted or new clinical protocols 3334 may also be submitted for government regulatory approval, professional medical association review and other agencies 3338 for consideration for new clinical treatment protocols based on clinical evidence supplied by electronic wearable devices in clinical use. The results of the various agencies 3338 reviews may then be communicated for action and guidelines to the computer processing of access and re-imbursement 3336 to the clinical treatment protocols and to the local hospital 3330 for their local computer processing 3330, 3332 of patient management protocols.

[00149] FIGURE 34 is a schematic flow chart to further and alternate details to the processing, analysis and derivation of normative values, performance targets and other decision making computing processes and tools for the clinician. In

FIGURE 34 input of information and / or data occurs via patient specific metrics 3420, doctor or clinical staff metrics 3422, measured parameters 3424 and event parameters 3426.

[00150] Patient specific metrics 3420 may include the patient personal data as described herein. That is data that may originate from the patient. The doctor metrics 3422 may include the clinical staff self reported data as also described herein. The patient metrics 3420 and doctor metrics 3422 may be communicated to a first database 3428, 1624.

[00151] The measured parameters 3424 may include quantities measured by the wearable device / brace such as: flexion, extension, temperature, walking / steps, compression pressure. That is the measured parameters may include the sensed values for the performance indicators and diagnostic indicators described herein. [00152] The event parameters 3426 may include reporting to particular events such as: medication (for example pain relief, blood thinning agents and the like), and the like. The particular events may be communicated by the wearable device, patient self reporting and / or clinical staff reporting.

[00153] The measured parameters 3424 and event parameters 3426 may be directly recorded / communicated 3430 to the first database 3428 with the aid of the apparatus and methods described herein. That is a "Patient Live" data stream where measured and event parameters are streamed in real time or at communication availability back to the first database and for first comparator analysis as described below. The measured and event parameters 3424, 3426 may also be processed and firstly compared by a computer processor to set thresholds or limits 3432, for example by the clinician, in order to derive three outputs to: alerts 3434, filter for clinician review 3436 and a first patient feedback 3438.

[00154] The alerts 3434 may be automated, immediate alerts to a Doctor, a nurse and / or a community health care professional (out-patient) for immediate follow-up. For example alerts may be generated in response to: the patient has fallen, has not significantly moved for a prolonged period, oxygen saturation is low and the like.

[00155] The computer processed filter for clinician review 3436 of measured and event parameters 3424, 3426 is automatically passed for further processing and analysis to provide input to the clinical decision making tool 3440. The clinical decision making tool 3440 on the basis of various inputs and analysis use a series of algorithms to make automated modifications of treatment 3430, 3322 by the wearable device / brace. Alternatively the clinician decision making tool 3440 may be semi- automated, requiring clinical staff approval before proceeding to change a therapy parameter.

[00156] The first patient feedback 3438 computer processed information may provide to the patient information to how they are performing with respect to their own performance targets. For example to amount of steps or walking,. The first patient feedback 3438 may be communicated to a second database 3442, 1624 for input into the clinical decision making tool 3440 as well as back to the patient as described with respect to FIGURES 18 and 19 as well as elsewhere herein. [00157] In addition the measured and event parameters 3424, 3426 may also be processed and secondly compared 3442 by a computer processor to normative values 3322, 3324 as well as against matched criteria 3444, for example those arising from common patient type/s. The results from this processing and analysis 3442, 3444 may then be communicated to the clinical decision making tool 3440 for processing with the other inputs into the automated clinical decision making tool 3440.

Furthermore the normative value and matched criteria processing and analysis 3442, 3444 may also be communicated to clinical staff for ward round prioritising (or "ward triage") and / or setting of patient appointments for follow-up 3446. In addition: in response to the analysis and prompting from the clinical decision making tool 3440, initiating clinical review of pain control or use of psychological coping strategies. Furthermore the clinical decision making tool may also prompt the clinician or other clinical staff to explore reasons if a performance target/s is not met.

[00158] In addition, the normative value and matched criteria processing and analysis 3442, 3444 may be communicated to the patient to provide a second patient feedback 3448 of "comfort graphs" and the like with reference to normative values. That is to provide a particular patient with a guide as to "how am I going" in comparison to other patients in their classified patient type. FIGURES 45 to 53 provide further examples to other patient communication and feedback formats.

[00159] The first and second patient feedbacks 3438, 3448 may be by visual or verbal feedback, encouragement, strategies to work towards achieving target and positive recognition. Also the feedback may be formulated to encourage patients to recognise and reward their achievements. For example as described below with respect to FIGURES 45 to 53.

[00160] In the following, one example to the invention with steps or walking by the patient is given. Definitive normative values with patient type for steps taken in a day during the course of recovery from orthopaedic surgery do not exist. As a general guide and example to performance targets or goals: in the first few days post operatively to TKR or hip joint replacement the patient may be expected to take steps a total of 40 minutes per day, broken into 10 minute periods. As recovery progresses over the next couple of weeks the goal in rehabilitation or at home may increase to steps / walking for a total of 1 to 2 hours per day in increasing periods of 15, 20, 25 and 30 minutes. The performance targets for number of steps may depend on the type of orthopaedic surgery, the patient type, the individual patient, the patient's support and as described elsewhere herein.

[00161] Referring to FIGURE 35, the number of steps may be sensed during the course of the day and logged by the electronic wearable device or "DOTS" device wearable device as a measured parameter 3424 / performance indicator. Then the steps or other movement sensed data 3520 may be processed as per FIGURES 33, 34 and as follows. The number of steps in each activity period, for the day or as appropriate may be streamed live in direct data recording / recordal 3430 to a first database 3428. Simultaneously or as appropriate the number of steps in a period may be first compared 3432 to set limits to provide a possible emergency alert 3434 if no steps have been taken for the day, by way of example. Secondly, if the number of steps is too low over a number of days then the processing filter 3436 to the clinical decision making tool 3440 may generate a Doctor report that the patient is

consistently underperforming to steps or walking performance targets. Thirdly the patient may be provided with a first feedback 3438 to their performance, or lack of, with respect to their own performance targets and past performance. Fourthly an update to a second database 3442, 1624 of the first comparator outcomes may be provided, which may also be accessed by the clinical decision making tool 3440. For example as described below with respect to FIGURES 45 to 53.

[00162] The steps in a period or day may also be secondly compared 3442 to normative values 3322, 3324 and matched criteria 3444 from the event parameters 3522 and / or the first and second databases 3428, 3442, 3524 to provide another set of three outputs. The first output from the second comparator may be fed in with other inputs into the clinical decision making tool 3440, 3322. One example to matched criteria and further inputs is where the amount of analgesia use, diarised pain scores by the patient and reporting by the electronic wearable device or "DOTS" device wearable device use allows for more accurate monitoring and diagnosis of the patient's progress against normative values. In particular to why a patient may not be progressing well and how the lack of progress may be addressed. The clinical decision making tool 3440 may then propose a revised step / walking performance targets together with particular targeted physiotherapy to range of movement exercises, wearable device

[00163] A third output from the second comparison 3442 and matched criteria 3444 may be to communicate to the patient a second derived feedback 3448 to advise them as to "How am I going? " for the step performance targets with respect to similar patients to them (within their classified patient type). Such feedback is often useful with those patients who have a tendency to "over do" their efforts, in such cases if they are given early feedback that they are over-performing then they are more likely to stay within more moderate, normative boundaries that are consistent with good recovery outcomes, rather than risk more injury or over compensating with pain relief and / or cooling. At the other extreme: tentative or hyper conservative patients may be encouraged and reinforced with realistic performance targets for their classified patient type and so be more likely to achieve a steady recovery progression.

[00164] Further advantages to the invention are as follows. Revised performance targets mean improved outcomes for patient recovery in that tailored targets are set which are customised with respect to the individual patient's abilities and needs, the clinician's experience together with normative data to the patient type ensure the best outcome according to best clinical practice from an evidence based perspective. Previously this has not been available or only haphazardly via anecdotal means. Clinicians in prior practice tend to rely on their own experience or their immediate peers as to expected patient performance goals with very generalised patient types.

[00165] Adjusted or new treatment protocols for a particular orthopaedic procedure may be efficiently: introduced, administered and monitored for expected outcomes across many patients with minimal effort by present clinical staff and the local hospital / medical administration region. Improvements in treatment protocols allow for faster more efficient recoveries with low revision rates across all patient types. In addition new multi-modal treatment protocols may be identified from metaanalysis of the extremely large automated data set that may be gathered in an ongoing fashion. For example sophisticated, early gait analysis to a type of total knee replacement implant and procedure may provide early indicators to issues with the implant or surgical procedure which may be caught early without a major revision and subsequent deterioration in the health of the patient or a cohort of patients.

[00166] FIGURES 45 to 53 and FIGURE 10 are a series of schematic diagrams to screen shots of a graphical user interfaces (GUI) and functionality of the invention. The example provided is from the perspective of the surgeon or other health care provider. That is the screen shots are for example from a mobile / cellular telephone, tablet computer or other like mobile device of the health care professional. The textual commentary in the FIGURES 45 to 53 and 10 provided in addition to the screenshots provides some guidance to real-time navigation of a series of GUI on a mobile / portable device. It will be readily appreciated that a range of health care clinicians may have different GUIs for their mobile device depending on their perspective as described herein. It will be readily appreciated that the GUI software and other analysis and diagnostic tools and algorithms associated with it for the clinical staff may be platform independent / "device agnostic" such that it may be interoperable and applicable across different mobile and computing devices as well as different operating systems.

[00167] Automatic measurement and data gathering of the patient's activities and responses may be provided by the wearable accelerometer patches or "dots" position and/ or motion sensors as described herein.

[00168] The invention shown in FIGURES 45 to 53 provides the patient with a customised daily program of activities and medication. It may also provide the patient with customised tips, pain management strategies and other wellness strategies that are more psychologically directed. Such automated and semi-automated patient care management may be continuously customised to the patient according to their type, progress and normative data as described herein.

[00169] FIGURE 47 provides an example of bar chart trend graph 4720 for an activity. The activity level (for example walking or knee flexion) on day X is good and to accepted normative values. However the activity level on the next day (X+l) is well below the individual patient average and the normative values for that type of patient. In addition the patient may report more pain, FIGURE 51. Accordingly the patient may be provided with tips and actions for pain management, FIGURE 49, and different exercises. At the same time the poor activity level as compared against the patient's own progress and / or normative values may also be reported to clinical staff for further analysis, monitoring and follow-up if warranted for the particular patient.

[00170] FIGURE 51 provides an example of a check 5120 that may be done of the patient prior to commencing an exercise. This check routine for pain in this example 5120, may be especially useful for preventing "overdoing" of some exercise routines by some patients. If the patient reports more pain or there is a trend of more pain over a number of days then this may flag that "overdoing" of an activity or exercise is occurring. If the patient is at risk of impeding their recovery process from "overdoing" something then automatic analysis, diagnosis and feedback may be given to the patient in the form of tips or pacing strategies to moderate or correct their behaviour. For example in the static quadriceps exercise routine , FIGURE 51, duration 5122 and frequency 5124 may be altered to individual durations of 10 minutes with a frequency of six times a day in response to "overdoing" by the patient pain self-reports of "A lot" 5126. Alternatively for a pain self-report of "Extremely" 5128 then the activity level may be altered to a minimal level to maintain movement with advice and medication to managing pain and possibly an alert to clinical staff for follow-up. In addition additional diagnosis questions may be done as described below with respect to FIGURE 52. If the undesirable behaviour progresses then an alert may be automatically sent to a clinician. The manual, original concept of active pacing (breaking up tasks into smaller manageable amounts) is described in "Manage your Pain" by Nicholas MK et al as referenced above. In addition automatic analysis, diagnosis and feedback may be provided to the clinical staff to pain medication, changes to exercise / physiotherapy routines, follow-up and the like.

[00171] FIGURE 52 provides an example of an adverse event one to two days post-surgery. The patient may be at home and notices a wound discharge which they report via a pick list 5220 as shown. This may occur independently or as part of the exercise check-list described above with respect to FIGURE 51. Accordingly an automatic alert may be raised and immediate messaging to appropriate staff to note, action and follow-up on is done. A wound discharge being a significant clinical indicator that should be followed up immediately and without fail. The patient may also be supplied with immediate advice to help alleviate the underlying cause. In addition they are advised to call their managing doctor / clinician to arrange care, an action which further aids in having the patient engaged in their own care management post-surgery.

[00172] FIGURE 53 has a number of examples of how a patient may be coached and receive immediate feed-back to their prescribed exercises. One example is a video demonstration 5320 to a high knee exercise. The patient may play the video 5320 to see a video and aural tutorial on how to do the exercise as well as any particular attention points relevant to their surgery and rehabilitation. Such exercises may also be relevant to "prehabilitation" programs undertaken by the patient prior to surgery. In another example the patient may select an x-ray image 5322 of their joint that has been operated on. The x-ray image 5322 may also have range of motion bars or limits, for example knee flexion and extension that are targets for their movement during an exercise. Additional bars or other indicators may be overlaid to show actual movement versus desired movement. The motion information provided to the GUI may be derived from motion sensors, accelerometer patches / dots worn by the patient as described herein.

[00173] In yet another example from FIGURE 53 the patient may select an animated three dimensional figure of the patient 5324 in the desired exercise or activity position/s. The three dimensional, virtual figure or avatar GUI may be interfaced to motion sensors, accelerometer patches / dots worn by the patient as described herein. Accordingly as the patient undertakes their exercises they receive real-time video feedback of how successful their motion is compared with desired motion. A patient with difficulties in visualing, perceiving or seeing their own limb motion may benefit from such live video feedback. In addition an avatar video may be relayed to a physiotherapist / clinician for real-time or later review with the patient.

[00174] It will be readily appreciated that in the examples described above with respect to FIGURES 45 to 53 that analysis, diagnosis, feedback and actions provided may be done on the basis of the processes described with respect to

FIGURES 33 to 35. Similarly the comparisons and thresholds used for an individual patient's performance and normative data to a patient type for a surgery or rehabilitation may also be done via the process described with respect to FIGURES 33 to 35 and as described elsewhere herein. [00175] In the examples described above with respect to FIGURES 45 to 53 and elsewhere it will be readily appreciated that automatic analysis, diagnosis, feedback and actions (including alerts) may be made on the basis of a single threshold value or multiple threshold values. Single threshold values for decision making may for example include self-reported pick list answers as for FIGURE 52 to wound discharge or a reduction in activity level from day X to X+1 as described for FIGURE 47. Multiple threshold analysis, diagnosis and actions may include multiple single threshold values compared, correlated or otherwise analysed as described above with respect to FIGURES 33 to 35.

[00176] The invention has been described for use in the acute situation and may also be used for other situations to high quality valued-based health care. For example after implantation of intra-spinal stimulators or drug delivery systems:

studies show many of these patients report ongoing distress and disability despite good pain relief. The invention may assist them in gradually upgrading their activity and confidence to function despite pain. The in-built treatment for psychological factors may help them to use and train with active pain management strategies in addition to the relief they receive from the implanted device of an intra-spinal stimulator and/or drug delivery system.

[00177] In another example patients with chronic knee pain who may wish to delay surgery may use the invention to learn and/ or be trained in active pain management strategies in a remote fashion. The use of strategies such as active pacing (breaking up tasks into smaller manageable amounts), applied relaxation, thought challenging and goal setting may provide a framework on which to build up their activity tolerance and also manage any pain they experience.

[00178] As a general example any patient recovering from surgery or an accident where ongoing pain is an issue may benefit from the use of this functionality of the invention.

[00179] The invention may have a series of alarms which can be

individualised to a patient's requirements. Using the principles of operant and classical conditioning patients may receive positive feedback for well-behaviours through a computer generated feed to their phone. Such feedback may be provided by the data gathering, analysis, diagnosis and tool kits of the invention as described herein.

[00180] A format of the feedback may also be altered depending on prior feedback history for a patient. For example patients may receive shorter educational feeds in response to triggering one or more alerts. The material may be tailored to their pre-determined psychosocial profile which was assessed before rehabilitation and one week before surgery.

[00181] Via the invention some or all patients may be recommended to undergo "Prehabilitation" that includes 4 weeks of a training and / or an exercise program pre-surgery with the invention as described herein. There is significant evidence that patients who undergo "prehabilitation" or otherwise preparatory training and / or exercise prior to surgery recover more quickly after knee surgery than those who do not.

[00182] Patients who may undergo a combination of activity upgrading and instruction on active pain management strategies (including use of principles of cognitive behavioural therapy) as part of "prehabilitation" may experience a better outcome after total knee replacement than those who have just exercises alone as part of prior art rehabilitation without the invention or do not have a period of

"prehabilitation".

[00183] Patients who undergo the "prehabilitation" and / or the rehabilitation program of the invention which includes online instruction on active pain

management strategies may show significantly improved function despite planning to postpone their knee replacement surgery and/or rely on conservative, prior art management.

[00184] Patients who have a knee injury may make significantly faster progress if they fully commit to the "prehabilitation" and / or rehabilitation of the invention. In addition, the invention may also provide for care management and alert strategies for those patients whose compliance is less than desirable.

[00185] FIGURE 1 is a schematic to a first flowchart to the invention described herein. The FIGURE 1 refers to a "PROVIDER" which may also be a surgeon or other appropriate clinician. The PROVIDER may interact with the invention as shown in FIGURE 1 and as described with respect to FIGURES 45 to 53 and 10.

[00186] FIGURE 2 is a schematic of table to the example Pacing rules of FIGURE 1. Pacing has been described herein with respect to the invention. This table or diagram show a pacing-up schedule that is used to ensure that patients make steady but consistent progress during rehabilitation to minimise pain increases and the use of strong analgesics.

[00187] FIGURE 3 is a schematic of a second flowchart to the invention.

[00188] FIGURE 4 is a schematic of a third flowchart to the invention as described further below and elsewhere herein. FIGURE 4 may also include the following:

In daily review - change to 'End of day review"

Add

Bothersome rating (0-10)

Happy with progress rating (0-10) in box with sloping side RIGHT TO LEFT arrow to decision box

"adjustment of pacing regime'

Every second day, they are given the prompt:

"From tomorrow, would you like to " in decision box

a) keep your exercise increases the same

b) increase your exercises at a faster rate

c) slow down your exercise increases

Arrow to

If they select option C twice in a row, there is an alert sent to the clinical team to contact the patient. - in box

Box- contact ? Resolution

Arrow back to end of day questions Arrow to questions below - each day patient asked for three days or until answers "a" or "b" for two consecutive days - then arrow to every "second day questions box "

From tomorrow, would you like to " in decision box

a) keep your exercise increases the same

b) increase your exercises at a faster rate

c) slow down your exercise increases

[00189] In addition FIGURE 4 may two further, daily questions for the patient: "How much did your pain bother you today? " and "How satisfied with your progress are you today? ".

[00190] FIGURE 4 may also further include reinforcement each day for progress. Another addition is a review by a psychologist if depression and OMPSQ scores very high, and left to it with prepared feedback, except for seeing GP about high pain levels. The offer of seeing a psychologist in the prehabilitation phase, may be initiated by high scores and the nurse / healthcare professional.

[00191] FIGURE 5 is a schematic is a chart to further details for the flowchart of FIGURE 4 and as described further below.

[00192] FIGURES 6 to 9 are enlarged schematics to portions of the flowchart of FIGURE 4 to show the text within in the flowchart of FIGURE 4 more clearly.

[00193] FIGURE 10 is a schematic of a GUI for an "app" or program interface of the invention that a provider / surgeon / healthcare professional may interact with as described with respect to FIGURE 1 and FIGURES 45 to 53 as well as elsewhere described herein.

[00194] Furthermore to the detailed descriptions with respect to Movement Sensing, Figures 1 to 10, 16, 33, 34 and 45 to 53 the invention also includes the following.

[00195] The invention may identify before surgery the approximately 15 to 20% of the patient population who are likely to not recover satisfactorily according to the usual trajectory or progression for the other approximately 80% to 85% of the patient population. The invention enables rapid and custom intervention with the those approximately 20% of the patients who are at risk of progressing poorly in the pre- and post-surgical periods, in order to prevent sub-optimal outcomes for those patients and to assist their recovery to satisfactory outcomes. The use of the invention may limit and / or reduce continuing post-operative pain, distress, and disability, as well as to minimise the need for readmission to hospital and associated additional costs.

[00196] A range of validated psychosocial questionnaires may be used individually and in various combinations as described here. The OMPSQ: Orebro Musculoskeletal Pain Screening Questionnaire (Short-form) Linton SJ, Nicholas M, MacDonald S. "Development of a short form of the Orebro Musculoskeletal Pain Screening Questionnaire. " Spine. 2011, Vol. 36, No. 22, pages 1891-1895.

www.spinejournal.com. The OMPSQ is a screening questionnaire that may be used to predict long term disability and delayed return to work due to personal and environmental factors. OMPSQ is a reliable predictor of disability in injured people experiencing pain. Another psychosocial questionnaire that may be used is the PSEQ (Pain Self Efficacy Questionnaire) as this is also a good predictor of future disability in those experiencing persisting pain: Nicholas MK. "The Pain Self-Efficacy

Questionnaire: Taking pain into account. " European Journal of Pain 2007; 11 : 153- 163. A further diagnostic questionnaire is the Pain Catastrophising Scale: Sullivan, Michael JL, Scott R. Bishop, and Jayne Pivik. "The pain catastrophizing scale:

development and validation. " Psychological assessment 7.4 (1995): 524. which is a good predictor of future chronic pain and associated distress and disability.

[00197] Other reviews to diagnostic questionnaires are also referred to below as Wylde 2012 and Forsythe 2008.

[00198] Importantly, once rapidly identified by the invention, those factors identified by the questionnaires in the invention may be analysed and communicated by the invention so that appropriately trained healthcare professionals may rapidly intervene with the invention to prevent further adverse progression or adverse clinical trajectory to the patient's recovery. For example rather than up to one to two weeks for adverse patient progression or trajectory to be identified, the invention may identify, alert healthcare professionals and start remedial therapy within one to two days. In so doing the outcomes following surgery may be improved for this high risk patient population. [00199] In another example, two successive requests from the patient via the invention to slow down the pacing upgrading schedule, described with respect to FIGURE 2, may also alert the clinician or other healthcare professionals to an emerging problem being experienced by the patient. The invention may also provide a diagnostic analysis to the likely nature of the problem based on historical patient and normative data as well as recent patient data. The invention with the clinician's approval may then trigger an intervention with the patient to clarify the problem and / or begin a remedial therapy program. This may be contrasted with prior art care where it may be several weeks before such problems may be detected, e.g. at the 6 week follow-up post-operation. Delayed detection of these problems risks complicating the recovery process for the patient and increases care costs incurred by the patient, insurer and local health service.

[00200] By way of comparative examples to the prior art for patients who had a total knee replacement (TKR) we refer to "Prospective relation between

catastrophising and residual pain following knee arthroplasty: Two-year follow-up ", by Forsythe et al. Pain Res Manage Vol. 13 No. 4 July / august 2008 and "The Role of Preoperative Self-Efficacy in Predicting Outcome after Total Knee Replacement. " by Wylde, S. Dixon & A.W. Blom. Musculoskelet. Care 10 (2012) 110-118, 2012, the contents of which are incorporated herein by reference.

[00201] In addition to the above measures by the invention, the invention may also provide real time or rapid feedback on the patient's progress with their physical exercises so that any incorrect or potentially problematic patient movements may be detected early by the invention and reported to healthcare professionals to reduce the likelihood of problems developing. For example the detection and diagnosis of patient movement problems may be done by analytics that may include detecting patient movement, analysing the patient movement to determine whether the patient movement is outside or beyond a set parameters for each specific exercise. Where the set of parameters may be at least two of the performance indicators as described herein for the patient and a patient population for normative data. The result of the analysis may then cause the invention to send an alert back to the patient to correct their movements depending on thresholds set for alerts. Where the alert sent to the patient may include a short note to reduce movement to within prescribed limits and / or remedial tutorials for the patient to provide guidance to aid the patient in adhering safely to prescribed exercise therapies.

[00202] The invention may also include a secure video link system to enable a surgeon or other healthcare professional to liaise directly with the patient should any problems that warrant immediate attention occur and arise outside of scheduled appointments. The invention may be used to rank and prioritise such alerts to the healthcare professional.

[00203] In use the invention may provide increased levels of patient satisfaction with their recovery and as a consequence improved levels of adherence to the exercise program than that achievable by the prior art. That is the invention may promote greater self efficacy by the patient or in other terms self-regulatory efficacy. By way of example self efficacy is described in a paper showing the importance of patients' self-efficacy beliefs for adherence to an activity program in arthritis patients in the face of pain flare-ups: Nancy C. Gyurcsik, Lawrence R. Brawley, Kevin S. Spink, and James D. Sessford. "Meeting Physical Activity Recommendations: Self- Regulatory Efficacy Characterizes Differential Adherence During Arthritis Flares ". Rehabilitation Psychology 2013, Vol. 58, No. 1, 43-50. Another prior art example is: "The Role of Preoperative Self-Efficacy in Predicting Outcome after Total Knee Replacement" by V. Wylde, S. Dixon & A.W. Blom in Musculoskelet. Care 10 (2012) 110-118.

[00204] The invention provides greater self efficacy by increasing patient satisfaction through the novelty and individual tailoring of the exercise program as a behavioural treatment producing a positive cognitive outcome; that is the invention may provide adaptive exercise programs depending on the historical data, normative data and the like as described herein. Furthermore patient satisfaction may be increased by the ability of the patient to more rapidly interact with the surgeon and / or the invention in the event of any difficulties.

[00205] In addition the invention may improve adherence to exercise programs through a 'pre-habilitation' practice phase, that is practice sessions prior to surgery and rehabilitation that are designed to familiarise the patient as to what is necessary post-operatively. The "pre-habilitation" phase by the invention may include daily, customised / adaptive feedback on patient progress to the patient to provide a form of positive reinforcement for the patient's efforts. The surgeon and / or other health care professionals may also provide feedback on weekly progress aided by the invention with respect to patient specific historical data as well as population normative data as described herein. A consequence of the invention's management of the patient is that in use the invention provides to the patient a feeling that the patient's surgeon and team of healthcare professionals fully supports them pre- operatively, at surgery and then post-operatively during recovery and rehabilitation. That is the invention develops, maintains and reinforces the patient's trust in their care providers. In addition the patient's trust and confidence is improved as the invention provides greater continuity of care on an hourly basis, daily basis and over weeks of rehabilitation. Furthermore where the patient is lacking in trust, confidence and improved continuity of care, the invention provides behavioural modifications therapies and with interventions to improve the patient's recovery trajectory by building trust, confidence (e.g. self efficacy) and continuity of care (adherence to rehabilitation program).

[00206] Furthermore patients who undergo / participate in a combination of activity upgrading and instruction on active pain management strategies (including use of principles of cognitive behavioural therapy) as part of "pre-habilitation" may experience a better outcome after total knee replacement than those who have just exercises alone as part of a prior art rehabilitation or do not have a period of "pre- habilitation". The use of the invention by the patient at "pre-habilitation" where it includes online instruction on active pain management strategies, may show significantly improved function despite planning to postpone their knee replacement surgery; in comparison to conservative, prior art management techniques.

[00207] As described herein the invention may provide data that indicates and verifies how adherent the patient has been with their rehabilitation with a high level of precision and accuracy. For example the invention may report and verify to: number of exercises completed and / or ROM (range of motion) on a daily and weekly basis.

[00208] As described herein the invention may accumulate data to individual patients and groups of patients. This data may be subsequently analysed to provide ongoing, improved detection of those patients predisposed or of high likelihood of having a poor recovery trajectory. In comparison to the prior art which uses the whole patient population data with no selectivity. The invention may aggregate detailed daily physical exercise / therapy data and questionnaire data over time for multiple patients. Then the invention may statistically analyse and determine with an improved level of precision and / or accuracy to the prior art which indicators are predictive of poor recovery. In addition further outcome measures such as the Oxford Knee Score (OKS) at 6 months after surgery for total knee replacement may also be used for patient data.

[00209] The physical exercise / therapy data indicators may include a number of exercises completed, which specific exercises were completed, range of motion (ROM) progression, questionnaire scores, responses to 'end of day ' status or well- being prompts, requests to decrease the standard pacing rate, see with respect and example to FIGURE 2. The statistical analysis and determination of indicators by the invention may further include the use of machine learning and artificial intelligence to provide for more rapid learning and predictions based on the accumulated data so that improved decision making algorithms and outcomes may be obtained by the invention.

[00210] In use the invention may provide the following substantial advantages to the prior art:

[00211] The invention may reduce a range of healthcare service provider utilisation indicators - such as fewer readmissions, fewer primary care appointments, and fewer physiotherapy appointments. The improvement in healthcare service provider utilisation may be by detecting patients who are not following the expected trajectory for recovery significantly earlier than is current practice and then providing intervention to improve or rectify their recovery trajectory. This improved healthcare service provider utilisation may be achieved by use of the invention as described herein and in addition to the daily monitoring of individual patient progress (unlike the usual prior art six week post-operative visit) by the invention.

[00212] Follow up visits by the patient to the surgeon and other healthcare professionals may be briefer, more productive and more directed due to the amount of information made available to the surgeon by the invention prior to the scheduled appointment. The invention may also provide a program application, "app" or interface, that provides to the surgeon tailored information regarding a specific patient's progression or trajectory compared to normative data, the patient's historical data as well as detailed daily basis data for the patient.

[00213] The invention may also reduce the amount of travel time and effort by patients in order to access health care providers. This is of particular advantage to patients with poor access to healthcare facilities. The invention may aid this by uploading information on a daily basis to health care providers rather than waiting for a scheduled appointment in order for the information to be provided to the clinical team. In addition the invention may also allow for less travel to be undertaken by health care practitioners, including car use, parking, train and availability of a healthcare support person.

[00214] The invention may save healthcare costs by significant changes in one or more of: fewer hospitalisations (e.g. for revisions, further examinations), fewer scheduled visits to health care practitioners for review of their progress, fewer primary care appointments and less use of physiotherapy. The invention may also reduce requirement for analgesics and subsequently reduced need for drugs to treat side effects such as nausea and constipation. Consequently also the likelihood of less tolerance to narcotics and addiction to narcotics may be substantially reduced.

[00215] The invention may also provide beyond rehabilitation: less lost work days, higher confidence to remain in the workforce and delaying retirement. The invention may also improve the patient's satisfaction and well-being by improving their sleep. Furthermore the patient may have less cognitive impairment postoperatively and more rapid recovery of cognitive functions.

[00216] In this specification, terms denoting direction, such as vertical, up, down, left, right etc. or rotation, should be taken to refer to the directions or rotations relative to the corresponding drawing rather than to absolute directions or rotations unless the context require otherwise.

[00217] Although the invention has been herein shown and described in what is conceived to be the most practical and preferred embodiments, it is recognized that departures can be made within the scope of the invention, which are not to be limited to the details described herein but are to be accorded the full scope of the appended claims so as to embrace any and all equivalent assemblies, devices, apparatus, articles, compositions, methods, processes and techniques.

[00218] In this specification, the word "comprising" is to be understood in its "open" sense, that is, in the sense of "including", and thus not limited to its "closed" sense, that is the sense of "consisting only of. A corresponding meaning is to be attributed to the corresponding words "comprise, comprised and comprises" where they appear.

Claims

1. A method for treating a joint of a patient, including the steps:

providing to the patient at least one of a validated psychosocial questionnaire, an OMPSQ questionnaire, a PSEQ questionnaire and a Pain Catastrophising Scale questionnaire;

analysing the questionnaire;

detecting patient movement;

analysing the patient movement to determine whether the patient movement is beyond a set parameters for each specific exercise; and analysing self efficacy from questionnaire and / or patient movement; wherein the set of parameters may be a plurality of performance indicators as described herein for the patient and a patient population for normative data.

2. A method according to claim 1, further including the steps:

providing a pacing schedule variation to the patient and obtaining feedback from the wearable device and the patient report on pacing schedule variation from a patient; analysing a number of pacing schedule requests with respect to at least one of a day, an exercise and a patient movement;

determining a pacing schedule variation; and

monitoring and education to avoid "underdoing " and "overdoing" of activity.

3. A method according to claim 1 or 2, further including the steps:

providing an intervention to a patient rehabilitation on the basis of at least one a questionnaire analysis, a patient movement analysis, a self efficacy analysis and a pacing schedule analysis.

4. A method according to any one of the preceding claims, wherein patient self efficacy is improved by at least one of: increasing patient satisfaction and adaptive / tailored exercise programs

5. A method according to any one of claims 2 to 4, further including the steps: adapting at least one of a pacing schedule, an exercise, a ROM, an analgesia, an applied relaxation technique and the use of problem solving and pain management strategies for an intervention.

6. A method according to any one of the preceding claims further including the steps:

patients undergoes a combination of activity upgrading and instruction on active pain management strategies; and

patient undergoes principles of cognitive behavioural therapy as part of

"prehabilitation" phase;

whereby the patient experiences a better outcome after total knee replacement than those who have just exercises alone as part of a prior art rehabilitation or do not have a period of "prehabilitation".

7. A method according to any one of the preceding claims further including the steps:

patient undergoes a "pre-habilition" phase, including online instruction on active pain management strategies,

wherein the patient significantly improves function despite planning to postpone their knee replacement surgery, in comparison to conservative, prior art management techniques

8. A method according to claim 7, further including patients who have a knee injury make significantly faster progress if they fully commit to and /or adhere to the method of the invention, the "re.cov.ery" program.

9. A method according to any one of the preceding claims, further including the steps of:

prioritising an appointment for a patient;

providing a secure video link between at least two of: a patient, a surgeon and a healthcare professional; and liasing directly with the patient by at least one of the surgeon and the healthcare professional;

whereby a rehabilitation or recovery progression problem with the patient is reviewed by the surgeon and / or healthcare professional.

10. A method according to any one of the preceding claims for treatment of respective joints of a plurality of patients, including:

communicating a plurality of performance indicators from a plurality of patients to a data analysis centre;

communicating a plurality of corresponding performance targets to the plurality of performance indicators to the data analysis centre;

communicating a plurality of de-identified and / or encrypted patient personal data to the data analysis centre; and

analysing the plurality of performance indicators, the plurality of performance targets and the plurality of patient personal data to derive respective normative values to at least one of a patient type and a respective patient;

wherein the respective normative data is provided to a respective clinician for a respective patient for at least one of determining and approving at least one revised performance target for the respective patient.

11. A method according to claim 10, further including the step:

providing patient adaptive exercise programs depending on the historical data, and the normative data

12. A method according to claim 10 or 11, wherein the patient personal data includes one or more of personal patient identifying data, a patient self-reported indicator, a pain report, a depression report or score, self-report measures of mood, function, disability, sleep, catastrophising, fear-avoidance, adjustment, injustice and quality of life; and

a clinical staff reported indicator, including: sleep periods.

13. A method according to any one of claims 10 to 12, wherein the analysis further includes analysing the patient personal data to classify the patient into a patient type for reference to a normative data set.

14. A method according to any one of claims 10 to 13, wherein the plurality of performance indicators includes at least one of a number of steps, a gait, a period lying down, an ambulatory period, a range of motion of the joint, range of movement distance travelled, walking speed, stairs climbed, compliance with prescribed exercise regime for the plurality of patients.

15. A method according to any one of claims 10 to 14, further including communicating the at least one revised performance target to the respective patient.

16. A method according to claim 15, wherein the analysis further includes:

analysing the at least one diagnostic indicator with respect to a patient personal data, a normative value, a patient type, normative value to a period from the surgical procedure, a normative value to at least one performance indicator; and

determining the revised performance target.

17. A method according to any one of claims 1 to 15, further including an approval for a rapid recovery treatment protocol in response to the analysis.

18. A method according to any one of claims 10 to 17, wherein the sensing further includes communicating the performance indicator to at least one of a clinical staff, the patient, a hospital and a data repository.

19. A method according to any one of the preceding claims, further including at least one of:

providing visual of verbal feedback, encouragement,

strategies to work towards achieving target and positive recognition, and encouraging patients to recognising and reward their

achievements.

20. A method according to any one of claims 10 to 19, wherein the revising of the performance target further includes:

initiating clinical review of pain control or use of psychological coping strategies.

21. A method according to claim 19 or 20, further including communicating at least one of a patient self-reported indicator and a clinical staff reported indicator to at least one of a clinical staff, a hospital and a data repository.

22. A method according to any one of claims 20 to 21, wherein the sensing of the performance indicator includes sensing at least one of a number of steps, a gait, a period lying down, a posture, an ambulatory period, a range of motion of the joint, an acceleration, an orientation, stairs climbed, distance walked and pain score at rest and an activity.

23. A method according to any one of claims 19 to 20, wherein the analysing further includes at least one of a normative data for the performance indicator, patient self-reported indicator and the clinical staff reported indicator.

24. A method according to claim 23, wherein the analysing further includes classifying the patient to a patient type from analysing at least one of the patient personal data.

25. A method according to any one of claims 10 to 24, wherein the revising of the performance target includes at least one of a clinical staff analysing the performance indicator, corresponding normative data communicated to the clinical staff, the performance target, the patient self-reported indicator, the clinical staff reported indicator to determine the revised performance target and exploring reasons if performance target not met.

26. A method according to any one of claims 10 to 25, further including communicating the diagnostic indicator to at least one of a clinical staff, a hospital and a data repository.

27. A method according to claim 10 or 26, further including analysing the diagnostic indicator with respect to at least one of a diagnostic indicator target, a normative data for the diagnostic indicator, patient self-reported indicator and the clinical staff reported indicator.

28. A method according to any one of claims 10 to 27, further including an approval for a rapid recovery treatment protocol in response to the analysis.

29. A method according to any one of claims 1 to 28, wherein an associated structure to the joint includes at least one of a portion of a limb attached to the joint, a limb including the joint, a leg, a thigh, a femur, a calf, a tibia, an arm, a humerus, a ulna, a radius and a foot.

30. A method according to claim 29, wherein the treatment to at least one of the joint and the associated structure includes at least one of a post-operative treatment after an orthopaedic surgery and a rehabilitation.

31. A method according to claim 30, wherein the orthopaedic surgery is at least one of total knee replacement, arthroplasty, femoral osteotomy and tibial osteotomy, condyles of the knee, ligaments of the knee and patella, fractures in and about the knee joint.

32. A method according to claim 31, wherein the orthopaedic surgery includes surgery to at least one of the associated structures and joints of the ankle, arm, elbow, wrist, hip and shoulder.

33. A method according to any one of claims 1 to 32, wherein a recovery time of the patient is reduced compared with a treatment without a revised performance target for the respective patient.

34. A method according to claim 33, wherein the reduction in recovery time is to at least one of: a movement of the joint, a load bearing of the joint, an inflammation of the joint, a pain of the joint and a mobility of the patient.

35. A method of treating a joint substantially as described herein.

36. A graphical user interface and /or method as substantially described with reference to Figures 45 to 53, 10 and accompanying text.

37. A wearable motion sensor "DOTS" and /or orientation sensor apparatus and /or method as substantially described herein.

38. An system according to any one of the preceding claims for treatment of a joint of a patient.

39. An apparatus according to any one of the preceding claims for treatment of a joint of a patient.

40. An apparatus according to claim 38, wherein the performance sensor measures at least one of a number of steps, a gait, a period lying down, an ambulatory period, a range of motion of the joint, an acceleration, an orientation, stairs climbed, distance walked and walking speed.

41. An apparatus according to claim 38 or 40, further including a graphical user interface to a patient's mobile computer device, wherein the GUI is used by the patient to self-report at least one of:

a pain score at rest,

pain score on activity, and administration of a medication.