WO2012129617A1

WO2012129617A1 - Cortico-spongiform-compressive fastening devices for single femoral and tibial tunnel double-bundle knee-ligament-reconstruction surgery

Info

Publication number: WO2012129617A1
Application number: PCT/BR2011/000081
Authority: WO
Inventors: George Guarany Philot; Antônio Alberto AFFONSO FILHO; Fábio Augusto CAPORRINO; Marcelo Apparicio Fernandes JUSTINO
Original assignee: Medvale Pesquisa E Desenvolvimento Das Ciências Físicas E Naturais Ltda.; Espaço Dumont Pesquisa E Desenvolvimento Ltda.
Priority date: 2011-03-28
Filing date: 2011-03-28
Publication date: 2012-10-04

Abstract

The invention comprises devices (D1 and D2) for cortico-spongiform-compressive fastening, in which the device (D1) is used for femoral fastening and the other device (D2) for tibial fastening, both devices being used in single tibial and femoral tunnel double-bundle and anterior cruciate ligament (ACL) ligament-reconstruction surgery. The femoral fastening assembly (D1) is composed of a flat-head cortico-spongiform screw (2), which has a hexagonal slot and a smooth body (6), with a proximal screw thread of variable length for spongiform tissue and a distal screw thread for cortical bone (RI and R2); the screw (2) has a hole (7) at the tip for the passage of threads (8); and it is connected to the base of a housing (3) for the tendons (4). The tibial fastening assembly is composed of two screws of hexagonal cross section (13), a circular engagement and reception cover, two threads (15) for secure fastening, a metal plate (16) forming a division into hemispheres, and two semi-circular compression domes (11), which function as bushings; the metal plate (16) has two distal protuberances (17), which are inclined at 90° in such a manner as to engage in the holes (18) in the semi-circular domes (11).

Description

"KNOCKING-COMPRESSIVE FIXING DEVICES FOR KNEE LINKING RECONSTRUCTION SURGERY WITH DOUBLE BAND AND FEMORAL AND TIBIAL TUNNELS"

It deals with the present patent application of unpublished "COMPRESSIVE CORNAL-SPONJOUS-COMPRESSIVE FIXING DEVICES FOR DOUBLE BODY LINKING RECONSTRUCTION SURGERY AND SINGLE FEMORAL AND TIBIAL TUNNELS", notably in the devices, tibial and femoral fixation. of the graft in the anterior cruciate ligament (ACL) reconstruction surgery that allow a simple surgical technique of high reproducibility, with low potential for complications, and there is no need for other access ways for femoral fixation, without the dependence of external guides, overturning or opening of clamping mechanisms. These devices attach to the bone with greater strength than any other known device, with the possibility of graft fixation closer to the normal ACL anatomy, and at a lower cost compared to current double band reconstruction techniques. .

ACL rupture is a highly prevalent lesion, with about 200,000 primary surgeries and 20,000 revisions (surgery after re-ligation of a reconstructed ligament) per year in the US ^1,2,3 .

The first reference to the treatment of ACL injury is from 1900, when Battle reports a case of primary repair, with two-year follow-up and good results ⁴ .

In 1903, Robson publishes a successful case of repair (suture of a ruptured ligament) and eight years of evolution ⁵ .

Hey Groves, in 1917, considers that suture ligament repair is practically impossible, and believes that ligament reconstruction is necessary ⁶ .

Note that repairing a ligament injury means suturing the ruptured ligament stumps to reconstruct its anatomy. When it comes to ligament reconstruction, this means creating a new structure that produces a function similar to that of the ruptured structure.

At that time, the importance of ACL as a primary restrictor of anterior knee translation was not yet known. The need for treatment was discussed. ligament, and it is believed that the treatment of meniscal injuries associated with ligament injury would be sufficient. This remained true until the early 1970s, when Feagin presented the initial results of repairing these injuries in West Point cadets at the Congress of the American Academy of Orthopedic Surgery.

However, in 1976, the same author published in the American Journal of Sports Medicine the five-year evolution of those cadets, with disappointing results, functional loss and knee instability.

McIntosh published in the Journal of Bone and Joint Surgery in 1977 a new technique for suturing the ligament behind the lateral femoral condyle. Marshall makes some modifications to this procedure creating the surgery of choice of the time.

In the 1970s, it was clear that ACL deficiency led to functional loss and needed to be rebuilt. Biomechanical studies were then started, with serial sectioning of the various knee ligaments ^7,8,9 , and the classic work of Slocum ¹⁰ , which created the concept of knee rotational instability, cannot be neglected.

Then, extra-articular reconstruction techniques emerged, which aimed to treat the medial anterus rotatory instability, not the anterior cruciate ligament, avoiding tibial subluxation and keeping it reduced in internal rotation.

Several procedures were created:

-Transference of the goose paw ¹⁰ ;

-Retension of the medial posterus capsule;

Advancement of the medial collateral ligament, more proximal and posterior;

After this type of procedure, the patient remained immobilized for a long time, which led to results with great movement limitation. Even so, these techniques were very popular in the 1970s.

In 1970, Jones described the use of the central third of the patellar tendon as a graft ¹¹ .

Kennedy & Fowler in 1971 demonstrate that the ACL can be injured without involvement of the medial structures ¹² .

In 1972, Galway described the "Pivot Shift", a clinical test used to date, which demonstrates rotatory knee instability, which is considered pathognomonic of ACL insufficiency ¹³ . Franke, in 1976, describes the use of free graft, bone-tendon-bone, patellar tendon, and its clinical effectiveness ¹⁴ . This type of graft was originally developed in Germany, although it was popularized by Clancy in the USA ¹⁵ .

Hugston, in 1976, created the concept of lateral anterol rotatory instability ¹⁶ . And then emphasis is given to procedures on the lateral knee to limit anterior tibial subluxation.

Mclntosh creates an extra-articular reconstruction with a tape of the tibial ilium tract (TIT), the lateral thigh muscle (known as Mclntosh I).

Torg, also in 1976, describes the clinical importance of the Lachman maneuver, which evaluates the anterior displacement of the tibia in relation to the femur in the ACL lesion, and is still currently used ¹⁷ .

And in the late 1970s, Losee & Ellison described other techniques using TIT. And Andrews creates a two-taped procedure of this structure, which for the first time takes into account different tensions in knee flexion and extension ¹⁸ ^'19 .

All extra-articular reconstructions decreased Pivot Shift initially, but did not work dynamically, loosening over time and progressing poorly over the long term. Patients again experienced knee instability, not to mention joint stiffness due to long periods of postoperative immobilization.

By the 1980s, treatment of knee instability due to ACL injury began to focus on the ligament itself.

Butler and Noyes, in 1980, describe the ACL as the primary tibial anterior translation restrictor ²⁰ .

Intra-articular reconstruction procedures closer to the anatomical ACL are then sought.

Insall, in 1981, is the first author to pass the graft intraarticularly. Based on the work of Ellison ¹⁹ , a TIT tape was carried inside the joint and fixed to the anterior tibial region ²¹ .

In 1982, Marshall abandoned the primary repair technique and began to use a fascia lata reconstruction technique ²² . _t

Mclntosh then modifies his original procedure, and passes a TIT tape, attached to his tibial insertion, over the top position (behind the lateral femoral condyle), into the joint, and back to the tibia in an intra-articular tunnel. Creating the technique of McIntosh II.

The same author created the Mclntosh III technique, using a quadriceptal and patellar tendon tape, attached to the anterior tibial tuberosity, which was carried into the intra-articular space through a tunnel in the tibia, being passed through the intercondyle in the "over position". the top "and fixed to the side of the femur.

Campbell used the medial third of the patellar tendon, trapping it in the anterior tibial tuberosity, and passing it through a tibial and femoral tunnel, attaching it to the side of the femur.

Thereafter, intra-articular techniques were developed, with two incisions, one in the anterior knee and one in the lateral thigh, and fixation on the post.

Clancy, in the USA, popularizes the use of the patellar tendon graft, originally developed in Germany, as already mentioned ¹⁵ .

The concept of the femoral tunnel position is fixed at about two millimeters from the posterior cortex. To define the position of the ligament in the femur, the clock face metaphor is created, with the femoral tunnel originating between 10 am and noon for the right knee and noon and 2 hours for the left. This position is based on the isometric point of the knee (the one in which, regardless of the position of this joint, the distance between the femur and the tibia will be the same, preventing graft stretching) rather than the anatomical position of the ACL. These concepts are still used today.

In 1986, Zarins & Rowe, popularized the use of flexor tendons (tendons of the gracilis and semitendine muscles) as a graft ²⁴ . This type of graft was originally described by Macey ²⁵ , and initially used by Cho in 1975 (semitendine graft) and later by Lipscomb in 1979 (Semitendine and Grácil).

Around the mid-1980s, video surgery techniques became popular. With the evolution of the technique, surgical instruments and fixation devices, in the 90's, the reconstruction of the ACL started to be done through a single incision in the anterior region of the knee, through the tibial arthroscopy, a technique currently used. . With these techniques, the results show that about 85% of patients feel normal or very close to normal knee, and 70% of operated patients are able to return to the preoperative level of physical activity.

Despite all the technical evolution, there are still around 10 to 15% of unsatisfactory results in ACL reconstruction surgeries. Be it because the reconstruction takes place in a single band, either by poor positioning of the tunnels or by failures in graft fixation.

Some authors report that 70% or more of the poor results are due to technical failures ²⁶ .

In addition, long-term follow-up of ACL reconstructions shows that even in patients without complaints of instability, progression to knee arthrosis occurs in more than 50% of cases, as shown in the authors' publications below:

Author and year Follow-up in months Radiological signs of arthrosis

Bach et al. 92 79 89%

Shelbourne & Gray 95 103 78%

Ruiz et al. 84 84 50%

Jomha et al. 2003 84 57%

Jarvela et al. 2004 84 47%

Aglietti et al. 2005 84 61%

Cohen et al. 2007 10 to 15 years 70%

Due to this percentage of failures, around the year 2000, seeking a reconstruction closer to the normal anterior cruciate ligament anatomy, studies on double-band reconstruction began, as anatomical data show the existence of these bands from the fetus.

In addition, biomechanical evaluations show that both ACL bands are tense at different times during knee flexion and extension. The medial antero band remains tense during almost the entire range of motion of the knee joint, while the posterolateral band presents tension close to the extension and rotates around the medial antero band, thus being an important rotational restrictor.

Double-band reconstruction is closer to the normal anatomy of the anterior cruciate ligament, but is technically more laborious and time consuming, ₍

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more likely to generate perioperative complications (both during and after surgery). We must remember that up to 70% of the bad results may be related to technical problems, even with single band reconstruction, as mentioned above ²⁶ . In addition, 85% of these surgeries are performed in the USA by non-specialist surgeons who perform less than 10 reconstructions per year, which greatly increases the risk of complications and poor results ²⁷ .

Another factor to remember is the cost of the surgical procedure, as two bands mean twice the fixation material for the ligament and nearly twice the surgical time, which automatically increases the cost of surgery and the risk of thrombosis, infection and anesthetic complications.

Considering these difficulties and risks, and that most surgeons are comfortable with single-band reconstruction, with their surgical times, with the available technique and instruments, and that their clinical results are quite good, the transition to reconstruction in Dual band has been questioned. Even the best surgeons do not routinely indicate it.

However, one cannot deny the existence of both LCA bands. And although it cannot duplicate the complex structure of this ligament (which is a set of multiple bands, and in anatomical dissections, in many cases up to 3 main bands, medial anterus, lateral posterus and intermediate) are evident, one can try duplicate the origin in the femur of two main beams and the insertion of these beams into the tibia, thus reproducing the two main ACL bands.

These two bands present tensions at different times during knee movement, so, in double band ligament reconstruction, they need to be tensioned independently.

So far, the only way this technique can be performed is by reconstruction with two independent tunnels in the tibia, with two screws, or any other fixation means that allow the two bands to be subjected to independent stresses.

The surgical technique of anterior cruciate ligament reconstruction is currently divided into the following major surgical times:

1- graft removal and preparation;

2- confection of the tibial tunnel; 3- confection of the femoral tunnel;

4- positioning of the graft in the tunnels;

5- fixation of the graft in the femur;

6- fixation of the graft on the tibia after tensioning it.

Note that in double-band reconstruction, when creating two tibial tunnels, we do twice the times 2, 3, 4, 5, and 6, practically doubling all the steps of the surgery, with all the possible complications characteristic of each time. being duplicated as well.

Ideally, we would have a simple, high-reproducible, low-cost surgical technique that would allow the creation of a new ligament with structure close to the normal ACL anatomy. And with a low potential for surgical complications through minimal patient intervention.

The new and original proposed devices allow the reconstruction of the ACL through a technique that reproduces the two bands of this ligament, with different and independent tensions, through a single tunnel in the femur and tibia.

In the current state of the ACL reconstruction technique, the first stage of surgery is to select and remove the graft that will replace the ruptured ligament, and prepare it for use.

In the case of flexor tendons, the tendons of the semitendineus and gracilis muscle are removed through an anteroid medial incision in the knee. These tendons are cleared of all muscle tissue, leaving only its tendon part. It is then sutured so that the tendon acquires a tubular appearance with a high strength surgical thread.

This suturing is performed by means of anchored stitches at each end of the graft, leaving the ends of the suture threads left over, so that there is a double cable of threads at each end of the graft. This is done with the tendon of each muscle separately.

In ACL ligament reconstruction, the use of flexor tendon grafts is one of the most widespread, widely accepted, and perhaps the most widely used techniques today.

In the innovative technique, the tendon preparation will be the same except that two different colored threads will be used to suture the ends of the tendons. tendons, so that each tendon has a different color at each end.

These tendons are prepared on a special side table and folded over themselves once, thus forming one end with four cables and the other with two loops.

The graft is then subjected to tension, tendon and suture to achieve its full potential for plastic deformation, and to cause any slippage that may exist at the tendon and suture interface, thereby causing the graft to reach its length. maximum before use.

While the graft is prepared by an assistant, the main surgeon, through two portals (incisions at the knee joint line), introduces the arthroscope into the knee, makes the joint inventory, and treats the meniscus and cartilage injuries. that are associated with ACL injury, and dries out the ruptured ligament remnants.

The second surgical time consists in the confection of the tibial tunnel.

A guidewire is positioned across the tibia and a positioning guide may be used for this.

Once the position of the guidewire, which corresponds to the insertion of the ACL into the tibia, is chosen, a cannulated drill of varying diameter is aligned with the guidewire and pierces the tibial tunnel from the anterior tibial cortex to the intraarticular space. The drill and guide wire are then removed.

In current techniques the diameter of this tunnel varies with the diameter of the graft that will be used. And in double band reconstructions two tunnels with a diameter of 5 to 7mm are drilled, with outlets in the inserts of the two bands of the ACL.

In the innovative technique, the tibial tunnel will always have a diameter of 11 mm, avoiding considerations about the graft caliber, using the same drilling technique.

It should be noted that the 11 mm diameter tunnel encompasses, in a single hole, most of the insertion area of the two bands in the tibia.

The third time of surgery is to make the femoral tunnel.

In standard technique, a guidewire is positioned at the desired location for the origin of the ACL in the femur, with or without the use of a trans-tibial guide. With the guide wire in position, a cannulated drill of varying diameter aligned with the guide wire pierces the femoral tunnel to the desired depth. The drill is removed and the guidewire may or may not be left attached to the femur, depending on the surgical technique used.

In the innovative technique, this tunnel will always have a diameter of 10 mm and a depth of 30mm. Simplifying, once again, the surgical procedure.

The fourth surgical time is to position the graft in the tunnels, which is currently done by traction of the guidewire, attached to the proximal end of the graft, in most types of femoral fixation (interference screw, "Endobutton", tie in post, "Rigid-Fix", "Ezlock", "AperFix"). In the case of transverse screws, the graft may be located by a steel wire through the femur and then pulled down through the femoral tunnel, joint and tibial tunnel out of the tibia. The graft hangs on the steel wire, and rises when the ends of the wire are pulled in opposite directions.

If the fixation is made by transverse screws, or "rigid-fix", a specific guide will be used to make the tunnels on the side of the femur so that they cross transversely the already perforated femoral tunnel.

If the fixation chosen is "Endobutton", the femoral guidewire is left in position; a second cannulated, 4.5mm drill is aligned to it and drills the rest of the femur in addition to the already drilled 30mm tunnel. Next, the guidewire is removed, and the total length of this tunnel is measured. Then the guidewire is reattached through the tibial tunnel and femur and is carried through the thigh muscles out of the patient. At its distal end, the proximal end of the graft is fixed, which, through traction of the guidewire, rises through the tibia and joint space, entering the femoral tunnel.

The new technique uses a variation of this same procedure, which is already known and widely used by surgeons.

The fifth surgical time is femoral graft fixation.

In the current surgical techniques, for the fixation of this type of graft (flexor tendons) in the femur, various types of devices can be used, which through different fixation forms, keeps the graft in its position until integration with the bone occurs. Like for example:

• Cortical suspension fixation - "Ligament Ancor", "Endobutton", pole tie and "Ezlock"; • Spongy suspension fixation - "Linx HT" and "AperFix";

• Fixation by cortical-cancellous suspension - transverse screws;

• Compression fixation - interference screws;

• Expansion fixation - "Rigid-Fix";

However, each of these techniques has specific difficulties:

• Anchors and Ezlock present technical difficulties in opening and fixing;

• Pole tying requires an accessory incision on the side of the thigh to fix a screw on the side of the femur, increasing surgical time and surgery morbidity;

• "Endobutton" relies on the apparatus overturning so that it rests on the bone at the femoral tunnel exit on the lateral thigh. Often, the rollover occurs in the middle of the musculature, compromising fixation and requiring an accessory incision to be made on the side of the thigh to position it. The biggest problem is that this is often missed during surgery, and compromises the outcome of the procedure, with loosening of the graft;

• Exclusive spongy fixation devices have lower graft fixation resistance and have not been popularized in the medium;

• Transverse, spongy fixation screws are one of the most popular fixations, but require an external guide and an accessory incision in the thigh to make the screw hole so that it crosses the femoral tunnel. This technique, in addition to longer surgical times and the accessory lateral approach, depends on the accuracy of the external guide, which if not correct, will not allow the screw to cross the graft, and still has the risk of cutting it at the moment of its placement;

• Rigid Fix also depends on an external guide, which must position two pins through the center of the graft, crossing the femoral tunnel, leading to the same risks;

• And the interference screws, which fix the graft by compressing the graft against the tunnel wall, present technical difficulties in its placement, which must be parallel to the graft, under penalty of cutting it. In addition, they depend on the integrity of the posterior cortical of the femur, since if the posterior wall If the tunnel breaks during its drilling or screw placement, it will not be able to compress the graft and may fall into the popliteal fossa behind the knee, causing extreme difficulties for its recovery.

These difficulties led us to seek a type of femoral fixation that can be considered definitive, and which, in addition, can create two graft bands with separate femoral insertions.

The proposed femoral fixation device, for double-band reconstruction in a single tunnel, allows a secure fixation without the need for accessory lateral access (necessary in the transverse screws and post tie), without depending on the posterior cortex for fixation. (required for jamming screws), and without opening or overturning any mechanism (such as "Endobutton", anchors, "Ezlock" and "AperFix").

Also, it does not depend on external guides, which can lead to mismatches between the clamping mechanism and the graft (transverse screws and "rigid-fix"). In addition, it makes surgery faster because fixation occurs at the same surgical time as the graft climb, whereas in most other methods fixation is done at a proper time.

Regarding the fixation resistance, the following table presents the characteristics of several femoral fixation devices ²⁸ :

Fastening method Stretch / Stretch / after Failure load Stiffness

20 cycles (Failure load) (Stiffness) In millimeters In% max. In newtons in newtons

Bioscrew 11.8 / 5.83 38.3 407.2 / 145.4 121.4 / 40.7

RCI screw 8.62 / 4.6 41.9 392.5 / 122.2 117.8 / 83.9

Rigidfix 4.62 / 1.13 46.5 994.4 / 233.6 138.4 / 20.8

Anchor link 6.33 / 1.78 62.1 340.1 / 79.9 91.2 / 12.2

Endobutton 4.19 / 1.32 58.4 850 / 189.8 112.5 / 9.7

Swingbridge 3.2 / 2.29 61.2 1359 / 214.1 162.6 / 45.8

Linx ht 4.18 / 2.08 55.8 439.7 / 136.7 115.7 / 21.5

Transfix 2.75 / 1.45 69 1469.7 / 315.5 206.7 / 29.7

Bio-transfix 2.62 / 1.39 70.3 1491.6 / 87.6 210.1 / 67.9

ACL 1.5 / 0.46 70 1025.5 / 201.8 83.23 / 18.2

Double finger extended lat 1, 71 / 0.43 74.4 1987.1 / 374.7 619 / 65.4 „

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Currently, the most resistant fixations are the cortico-spongy (transverse screws), with pullout resistance averaging 1500N (Newton).

The femoral cortex is capable of resisting 400N per mm of cortical thickness.

A standard 4.5mm cortical screw, anchored in only one femoral cortex (on one of the femur walls), can support about 2500N ²⁹ .

The innovative device will fix by anchoring the femoral cortex with a standard 4.5mm thread. Therefore, the expected resistance to the device is at least 2500N. And this resistance is increased by the spongy fixation to be made on the bone between the end of the tunnel and the anterior cortical wall of the femur, and by the compression of the graft against the tunnel wall when the device enters it.

In addition, fixation is performed in the anterior cortex or lateral anterum of the femur, without risk of reaching blood vessels or nerves in the posterior knee (which may occur with transverse fixations if the surgical technique is not correct).

It should also be noted that in the option of reconstruction in two bands, with two femoral tunnels, these tunnels should be separated by a bone wall from 1mm to 2mm thick, to avoid collapse between them. Drilling such close tunnels is technically difficult, with a greater chance of complications, with increasing time and surgical cost ^30,31 .

The device proposed here allows the creation of two bands with a single tunnel and a single fixation, making the procedure faster, simpler, safer, and cheaper.

Another problem that surgeons face in ACL reconstructions is the widening of bone tunnels after surgery. This occurs mainly in the fixation with transverse screws and "Endobuttons". In these cases, fixation is performed suspensively, away from the joint surface, allowing movement of the graft within the tunnel, which causes bone resorption in its walls, and the consequent widening of the tunnel.

This innovative device fixes the graft near the articular surface, preventing graft movement within the tunnel, preventing enlargement from occurring. The device still keeps the graft away from the screw thread, protecting it. In addition, it separates the two graft bundles by the diameter of the device, which places them in the center of the original insertion of the two ACL bands, which are anatomically 10mm apart. ³²

Finally, in cases of new ligament injury, the removal of this new device preserves excellent bone stock, allowing a new ligament reconstruction at the same surgical time as its removal, be it the metallic, osteoinductive or bioabsorbable device. This is often not possible with the interference screws, which when removed leave a dead space that prevents the drilling of a new tunnel, forcing the surgeon to perform two surgical times, one for removing the screw from the first surgery, and another after of 6 months or more (time required for screw hole to close with new bone) to rebuild ligament.

In case of need for removal of the femoral fixation device, a specific instrument was developed that fixes the screw while it is unscrewed, allows the rest of the device to be extracted, and prevents it from falling into the joint.

This provides a safe, low-cost femoral fixation (even in the case of double band), technically faster and easier, without the need for accessory pathways or external guides and lower perioperative morbidity.

The surgical technique for the use of the device is very similar to the conventional femoral fixation techniques, with which surgeons are accustomed, however, it allows the reconstruction of the two ACL bands with a single tunnel, which is the great and distinct differential, without the risk of injuring the graft during fixation, and allows review in a single time.

In addition, it has greater fixation resistance than any other type of femoral fixation.

The device, despite creating two independent bands in the femur, can be used without any harm in a single band reconstruction while retaining all of its fixation advantages.

The last surgical time of reconstruction is to tension the graft and fix it on the tibia. In the current state of the single-band reconstruction technique, the graft is tensioned through the tibial tunnel, and once the desired tension is reached, the tibia is placed in an anatomical position relative to the femur (because in ligament injury it is forward) and the graft is fixed by the desired method.

Among the various options are:

- pole fixing;

- interference screw;

- "Washerlock";

- "Intrafix";

- staples.

All options are well accepted and widely used, but each with its own peculiarities:

- Post fixation lets the screw head protrude into the medial anterum of the tibia and this can lead to constant patient discomfort. In addition, by making the fixation outside the tunnel, the mobility of the graft within the tunnel increases, allowing its widening ³⁰ . This type of fixation still has the risk of reaching blood vessels in the posterior tibial region when bicortical fixation is performed ³³ .

- Washerlock and staples have the same characteristics. And some authors report that compression of the staples leads to necrosis of the grafts under it ³⁴ .

- Interference screws and "Intrafix" allow the tunnel to be obliterated, reducing the movement of the graft inside, thus reducing the chances of tunnel widening. However, the interference screw, when compressing the graft against the tunnel wall, has the risk of cutting it with its thread.

- Intrafix also compresses the graft against the tunnel wall, but protects the graft through a bushing around the screw.

However, neither allows independent tension between the graft cables within the same tunnel.

Thus, in the state of the art, double band reconstruction with different tensions between them requires the drilling of two tunnels in the tibia, and the use of two fixation devices, thereby increasing risks, surgical time and cost. of the procedure. We then looked for a new way to fix the two bands of the new ACL to the tibia, with independent tensions, but in the same tunnel.

For this purpose, an innovative and innovative tibial fixation device similar to a wall bushing was created, however, in which each half expands independently, which allows the fixing of the bands at different tensions and separately.

For its use, the only difference from current techniques will be the creation of a groove in the tibial cortex at the tunnel entrance. For what developed a specific chisel.

This groove is intended to guide the device, separating the tibial tunnel into two halves, and is performed shortly after drilling the femoral tunnel, just before placing the graft in the tunnels.

After the femoral fixation, the graft cables will be removed at the tunnel entrance, and the tibial fixation device will be introduced into the tibial tunnel, with the aid of a specific instrument, dividing it in two with its central plate, separating a graft cable into each half of the tunnel.

The knee should be placed in the position of fixation of the medial anterior band, between 45 and 60 degrees of flexion. And this band will be subjected to a desired tension with the use of a dynamometer.

By inserting the screw corresponding to this half of the tunnel, the device will expand only from this side, securing the first graft band with bending stress.

Meanwhile, the central plate of the device, resting on the bone around the tunnel, keeps the second graft cable free of pressure.

With the knee positioned between zero and ten degrees of flexion, the posterolateral band is tensioned and fixed in the same manner by the introduction of the second screw, which expands the remaining half of the sleeve.

Many surgeons do not rely solely on compression fixation within the tunnel. They use graft fixation with an interference screw, followed by a secure fixation with a pole tie, trans-bone tie or staples.

The device proposed here also allows a security fixation, made through a graft tie in a plate that is supported on the cortical tibia, and also attaches to the central dividing plate of the tibial device by means of another tie. With this, the device is anchored in the anterior cortical of the tibia, as well as the graft cables.

In case of need for removal of the device, we developed a specific instrument that fits into it after the removal of the cortical support plate, and allows its extraction from the tibial tunnel.

In the following, the invention is explained with reference to the accompanying drawings by way of illustration and not limitation:

Figure 01: Exploded perspective view of the femoral fixation assembly;

Figure 02: Perspective view of the assembled femoral fixation assembly;

Figure 03: Inverted perspective view of the assembled femoral fixation assembly;

Figure 04: Exploded perspective view of the tibial fixation device;

Figure 5: Detail of the connection between the snap-on cover and the compression domes;

Figure 6: Detail of the mounting of the tibial fixation device and the fit between the central plate of the device and the compression domes;

Figure 7: Perspective view of the tendon preparation base;

Figure 8: Perspective view showing the beginning of tibial tunnel perforation, with positioning of the guidewire;

Figure 9: Perspective view showing the beginning of tibial tunnel drilling with the cannulated drill;

Figure 10: Perspective view showing the tibial tunnel perforation with the cannulated drill piercing the tibial bone;

Figure 11: Perspective view showing the completed tibial tunnel and placement of the femoral guidewire with the aid of the trans-tibial guidewire;

Figure 12: Perspective view showing the trans-tibial femoral guide orienting the guidewire entry point into the femur;

Figure 13: Perspective view showing the guidewire running through the entire femur;

Figure 14: Perspective view showing the guidewire held in the same position as the previous figure, with the removal of the femoral guide and introduction of the cannulated drill to the femur; Figure 15: Lateral view showing the guidewire through the femur and the 10mm cannulated drill bit piercing a 30mm deep tunnel and preserving 2mm of intact bone on the posterior wall of the femur;

Figure 16: Side view showing the guidewire held in the same position at the femur, and a 4.5mm cannulated drill bit piercing the remainder of the femur beyond the 30mm tunnel;

Figure 17: Sectional view showing detail of the femoral tunnel;

Figure 18: Perspective view showing introduction of graduated ruler through tibial and femoral tunnels;

Figure 19: Perspective view showing the two lateral and opposite tears made in the tibial inlet cortical, with detail of the notch;

Figure 20: Perspective view showing the guidewire detailing the holes at its distal end and the traction wires of the femoral device;

Figure 21: Perspective view showing the complementary ends of the wires running through the femoral fixation assembly, returning to the remaining holes of the guidewire, and carried through the tunnels;

Figure 22: Perspective view showing fixation of the femoral joint by means of the cortical-cancellous screw pulled by the wires;

Figure 23: Perspective view of traction wire removal after fixation of the femoral device;

Figure 24: perspective view of the femoral joint fixed to the femur with the bands crossing the tibial tunnel, with correct positioning of the screw, capsule and graft, showing detail;

Figure 25: Perspective view showing the tibial device in relation to the two graft bands;

Figure 26: Perspective view showing the tibial device being inserted into the tunnel in relation to the two graft bands and with its central metal plate aligned with the groove made in the anterior tibial cortex;

Figure 27: Perspective view showing the tibial assembly coupled to a hammer that fits into the central plate of the tibial assembly;

Figure 28: Perspective view showing end of socket hammer showing detail;

Figure 29: Perspective view showing the tibial joint near the tunnel, being impacted with the aid of a hammer;

Figure 30: Perspective view showing the placement of screws in the tibial device;

Figure 31: Perspective view showing the use of a hand-held dynamometer that grasps one of the graft bands by forceps while this graft band is tensioned and independently fixed with the knee flexed;

Figure 32: Perspective view showing the use of the same manual dynamometer securing the other graft band through its tweezers while this graft band is tensioned and independently fixed with the knee positioned in a position close to the extension;

Figure 33: Perspective view showing the devices in their proper place, showing the excess cut of the bands with scalpel aid;

Figure 34: Perspective view showing the closure of the graft fixation procedure;

Figure 35: Perspective view showing reinforcement plate placement, without cutting the excess tendons;

Figure 36: Perspective view showing the tie-up of the reinforcement plate in the central plate of the tibial device;

Figure 37: Perspective view showing the end of the procedure detailing the binding of the two graft bands on the reinforcement plate;

Figure 38: Perspective view showing the tibial puller of the tibial fixation device;

Figure 39: Perspective view showing details of the tibial extractor;

Figure 40: Perspective view showing impaction of hammer puller opposite tibia showing detail;

Figure 41: Perspective view showing the hexagon socket wrench to unscrew the femoral screw;

Figure 42: Perspective view showing the wrench attached to the femoral screw puller;

Figure 43: Perspective view showing the femoral screw puller attached to the wrench, removing the femoral screw in detail;

Figure 44: Perspective view showing extraction key handling femoral artery and screw connection details.

The "COROUS-SPONY-COMPRESSIVE FIXING DEVICES FOR SINGLE KNEE BANDING AND FEMORAL AND TIBIAL TUNNEL CONNECTION RECONSTRUCTION SURGERY", the subject of this patent application, consist essentially of devices (D1 cortico fixation). compression device, where device (D1) is used for femoral fixation and another device (D2) for tibial fixation, both applied in double cruciate ligament reconstruction surgery of the knee, in double band with single tibial tunnel and femoral.

Basically, the first device (D1), ie the femoral fixation assembly, is composed of a cortical - cancellous screw (2) coupled to a graft support base (3), which will also compress it against the bone, to be used in the femur.

Figures 01, 02 and 03 show the femoral fixation assembly (D1), with its flat-head, flat-head hexagonal slotted screw (2) (6), with a proximal screw thread. variable length for cancellous tissue (R1) (according to the size of the screw) and a distal cortical bone thread (R2), about 4mm in length, these two threads (R1 and R2) being discontinuous. The screw (2) has a hole (7) in the tip for passing the "ethibonde" wires (8) used to pull the device. This screw (2) has its length previously determined by the measuring procedure with a graduated ruler (9) shown in Figure 18. It connects to the support base (3) of the graft (4), which is fixed to the assembly by a sturdy suture (10) as shown in detail in figure 2.

The ends of the tendons that form the graft (4) will be sutured with high strength and biocompatible "ethibond n ° 2" or similar wire at their ends with distinct colors (C1 and C2) on opposite sides forming a bundle. double, identified by the different colors in the suture (C1 and C2). Near the vertex of this tendon bundle (4), another bandage is made, with the same thread of different colors in order to mark the tendon cords (E1 and E2) in their part. near the support base (3).

The second device (D2) is similar to a wall bushing, but with independent expansion of each of its halves (11), which will make the spongy and compressive fixation of the tibial graft, coupled to a plate (12) fixation in the tibial cortex.

Figures 4, 5 and 6 best demonstrate the second device (D2) of the tibial assembly, which consists of two hexagon socket screws (13), a plug and receive circular cap (14), two wires (15) of " ethibonde "number 5, for securing, a hemisphere divider metal plate (16) and two semi-circular compression domes (11) which function as bushings. The domes (11) must be inclined (a) to be mounted and integrated with the circular cover (14) together with the hemisphere divider metal plate (16).

The metal plate (16) has two protrusions (17) distal inclined ⁰ to 90 in order to fit accurately in the holes (18) of the semicircular dome (11).

Figure 6 demonstrates, in detail, the configuration of the domes engagement (11) next to the circular cover (14). This device causes the set to become indivisible when closed in the shape of the tibial fixation set (D2).

More particularly, the devices (D1 and D2) are usable for ligament reconstruction of the anterior cruciate ligament based on known surgical techniques as described below:

After the patient is properly prepared on the operating table, in horizontal supine position, an incision of about 5 cm is made in the anteromedial region of the tibia, over the insertion of the hamstring muscles, also called goose paw. The tendons of the gracilis and semitendinosus muscles are isolated by dissection, and these tendons are removed for use as a graft (4), with the aid of a tendon puller, an instrument commonly used in this type of procedure.

These tendons are cleaned of all muscle tissue, leaving only the tendon itself.

The tendons are then brought to a base (B) for preparation where they are tensioned (Figure 7). This base (B) allows the alignment of the two tendons, forming the graft (4) which are sutured with high strength wire and biocompatible, "ethibond n ° 2", or similar, at their ends, with distinct colors (C1 and C2) on opposite sides, forming a double bundle, identified by the different colors in the suture. Near the vertex of this tendon bundle, which will be called a graft (4), another alignment is made with the same wire of different colors (E1 and E2) in order to mark the tendon cords at this other end, so that they can be individualized. when they are fixed to the femoral tunnel.

This tendon bundle is positioned at the base (B) by means of the separator (19) and its tips are attached to two tweezers (20) on the opposite side by their handles (21). The beam at this stage is fixed by the handle (22). After properly prepared, the graft (4) should be gradually stretched under the control of a dynamometer (23) through the hook (G) in order to maintain a constant numerical tension while waiting for its use in surgery, ensuring that There is no risk of variation in length and no residual slip at the tendon and suture interfaces. This procedure is called pretensioning.

Concomitantly with the preparation of the graft (4), which is performed by an assistant, the surgeon makes two skin incisions, about 1 cm, at the knee joint, one medial and one lateral, which will be used for the entrance of the graft. arthroscopy and surgical materials in the knee, since the ligament reconstruction procedure is all performed by arthroscopy.

After the inventory of the joint and the treatment of meniscal and chondral lesions that may be associated with ligament injury, the perforation of the tibial tunnel begins (Figure 8). A guide wire (24) with a 3.2 mm diameter drill tip is installed using a bone perforator in the center of the tibial insertion of the anterior cruciate ligament, with or without the aid of a specific guide.

The tibial bone (25) is punctured until the tip of the guidewire (24) reaches the articular surface (A) of the tibia (25) through the cartilaginous tissue without advancing to other structures, precisely accompanied by arthroscopic vision. . Next (Fig.9), the guidewire (24) is held in its previous position and a cannulated drill (26) and graduated, 11 mm in diameter, is introduced aligned with it, piercing it. the tibial tunnel (T), as shown in figure 10. ,

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Care should be taken not to advance the drill into other structures such as the posterior cruciate ligament or the femoral bone and cartilage, and the surgeon is always guided by arthroscopic vision.

After this procedure, both the guidewire (24) and the cannulated drill (26) are removed from the tibia (25), leaving only the tunnel (T), free for the next surgical time.

Shortly after the tibial tunnel (T) is completed (Fig. 11), the femoral tunnel guidewire (27) is introduced through the tibial tunnel (T) itself, with or without the aid of the trans-tibial guide (28). , being placed in the femur bone (29) at the desired point for the origin of the anterior cruciate ligament to be reconstructed. This point should be in an isometric position at the knee joint, and should be positioned so that the tunnel to be drilled is about 2 mm from the posterior cortical of the femur.

Figure 12 demonstrates the trans-tibial femoral guide (28) orienting the guide wire entry point (30) into the femur (29).

When the femoral guide (28) is carefully positioned (fig.13), the guide wire (27) should traverse the entire interior of the femur bone (29) until it ruptures its anterior cortical surface.

Figure 14 demonstrates that the guidewire (27) is held in this same position while the femoral guide (28) is withdrawn, and thereafter, aligned with the guidewire (27), a cannulated and graded drill 10 is introduced. mm in diameter (31). As shown in Fig. 15 this cannulated drill bit 31 will progress around the guidewire 27, drilling a 30mm deep femoral tunnel 29, keeping 2mm of intact bone wall in the posterior region of the femur.

Then (fig.16), the 10mm cannulated drill bit (31) is removed and replaced by another 4.5mm diameter cannulated drill bit (32), also aligned with the guidewire (27), which advances by drilling around it. of this wire until it breaks the anterior cortical of the femur, thus creating the widening of the entire canal left by the guide wire (27). Figure 17 shows, in section, the detail of the femoral tunnel and the diameter of the channel prepared in such a way (33) for later insertion of a screw.

Through the tibial and femoral tunnels (fig.18) a L-shaped graduated ruler (9) is introduced to measure the total size of the femoral tunnel (equal to the sum of the 10mm diameter and 4.5mm ,

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in diameter). This measurement determines the size of the femoral screw to be used. All the instruments are then removed from the knee.

The next step (fig.19) is to make two opposing lateral (R3) tears in the tibial inlet cortical through the double chisel (34) impacted by the hammer (35), just enough to penetrate the cortical wall of the bone. tibial (see detail of fig.19), creating a notch (R3).

A new surgical time (Fig. 20) begins with the reintroduction of the arthroscope and, under visual control, the graft guidewire (36) is introduced through the tibial tunnel (T), joint and tunnel (T). femoral. This guidewire (36) is pushed toward the femur (29) until it punctures the thigh muscles and skin.

The guidewire (36) has at its lower end four holes (F1, F2, F3, F4)). In two of these holes (F1 and F2) two "ethibonde" number 5 wires (8) are introduced for traction of the femoral device by the guide wire (36).

The other two ends of the wires (8) pass through the femoral fixation assembly (D1) through the hole (7) at the tip of the cancellous cortical screw (2) already attached to its base (3) and the graft (4), and re-drill the remaining two holes (F3 and F4) of the guide wire (36) (fig.21). Then, the guidewire (36), exposed on the side of the patient's thigh, is pulled by the surgeon through the tibial tunnel and the femur tunnel, leading and exposing on the outside of the thigh the four segments of the " ethibonde "number 5 (8).

The graft (4) is attached to the base (3) of the femoral fixation device (D1) by means of a tie (10) with number 2 "ethibonde" wire (Fig.02), seen in detail along with the sutures (E1). and E2) identifying the two graft cables.

Note, in Figure 1, that the central hole of the graft support base (3) is smaller than the diameter (R1) of the cancellous screw bone (2), which makes the screw assembly (2) and indivisible support base (3) if it has to be removed from the bone.

Figure 3 shows the details of the graft curvature (4) and its attachment to the support base (3).

The next surgical time (Fig. 22) is the fixation of the femoral joint (D1) to the femur (29) through the cortical-cancellous screw (2). The screw (2) is pulled by the number 5 "ethibonde" wires (8), externalized on the side of the thigh, and screwed ,

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with a hexagon wrench (37), which enters through the tibial tunnel and fits into the head of this screw (2).

The cancellous thread (R1) discontinued with the cortical thread (R2) of the screw (2) will prevent its progression when it reaches the cortical bone. This prevents it from advancing through the cortex beyond the 4mm of its specific bone thread (R2) (the average thickness of this cortical is 4mm), thus preventing the progression of the tip of the screw (2) from disturbing it. the thigh muscles.

After fixing (fig.23), the number 5 "ethibonde" wires (8) must be completely removed from the inside of the screw (2) and from the surgical field, by pulling each cable independently.

Figure 24 shows the detail of the correct positioning of the screw (2), support base (3) and graft (4), inside the femoral tunnel (T). The markings (E1 and E2) can be observed through the arthroscope, identifying the two graft bands, called anteromedial and posterolateral, at the entrance of the femoral tunnel (T). The result of this procedure will be the creation of two graft bands (38) by the two tendon bundles attached to the femur (29) which will traverse the joint, replacing the two bands of the ruptured anterior cruciate ligament. These two tendon bundles, hereinafter referred to as the bands (38), will pass through the tibial tunnel (T), and will exit through the entrance hole in the anterior tibial cortex (25), being apparent from the outside (T) of the Tibial tunnel.

At this stage (Fig. 25) the introduction of the tibial assembly (D2) is prepared, keeping the two bands (38) of the graft apart.

As described in Figure 4, the metal plate (16) has two distal protrusions inclined at 90 ⁰ (17) so as to fit accurately in the holes (18) of the semicircular dome (11).

This configuration allows the assembly to be introduced into the tibial tunnel (25) without the hemisphere-dividing metal plate (16) disengaging from the intended direction.

After the two bands (38) are removed, the tibial fixation assembly (D2) is pressed close to the existing tibial tunnel, aligning the hemisphere-dividing metal plate (16) with the two slots (R3) at the entrance to the tibial tunnel ( fig.26). The tibial fixation assembly (D2) is impacted with the aid of a hammer (39) of ,

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it fits into its center plate (16) (fig.27), the end (40) of which engages and surrounds the edge surface of this hemispherical metal plate (16) so as to guide the assembly without the risk of escape , to its ideal position, as can be seen in detail in figure 28.

Figure 29 demonstrates the impaction of the tibial joint (D2) into the tunnel with the aid of a hammer (35) and hammer (39). This impaction should be sufficient to conceal the entire tibial fixation assembly (D2) within the tibial tunnel (T) flush with the external face of the tibia (25).

After impaction (fig.30), two hexagon socket screws (13) are inserted into the two holes of the circular cap (14) in order to expand the two hemispheres (11) of the tibial fixation assembly (D2), pushing them in opposite directions, similar to opening a wall bushing, however, with each hemisphere expanding independently.

To reiterate, the screws (13) are responsible for the fixation and constant pressure of the two graft bands close to the spongy wall of the tibial bone (25), separated by the hemisphere dividing metal plate (16), in two bands ( 38) distinct within a single tunnel (T) with independent voltages.

With the knee between 45 and 60 ° of flexion (fig.31), a manual dynamometer (41) is used that holds the anteromedial band of the graft through its forceps and handle (42), identified by marking through a color suture. (C1), referring to its position, and allowing its identification, both inside the joint, near the femoral fixation (E1), and outside the tibial tunnel. With this graft band subjected to the tension desired by the surgeon, the first screw (13) is tightened with the hexagonal tibial wrench (43), the force vector direction can be observed in the second image of figure 31.

When the screw (13) expands this hemisphere (11) from the tibial fixation assembly (D2), it compresses the anteromedial band against the wall of the tibial tunnel (T) exclusively on this side of the tunnel, securely fixing it. Note, tensioned with the knee flexing.

The hemisphere-dividing metal plate (16), supported by the cortical and cancellous bone, keeps the other half of the tibial tunnel still free of compression.

With the knee between 0 and 10 ° of extension (fig.32), the same procedure will be repeated with the posterolateral band, identified with the different color of the „

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suture (C2 and E2) by firmly tightening its corresponding screw (13) with the hex wrench (43) after subjecting this band to the desired tension with the dynamometer (41).

After making sure that the two screws (13) are properly tightened, flexion and passive extension movements of the operated limb are performed, and knee stability is tested by specific clinical examination (Lachman tests, anterior drawer and pivot). shift).

If the surgeon is satisfied with the fixation obtained, the excess of the band ends (38) is cut with the scalpel (44) (fig.33), and the ethibond auxiliary wires are removed (15). ) from inside the tibial fixation assembly (D2).

The graft fixation procedure is completed, as shown in the drawing in figure 34.

Surgical wound closure and surgical wound dressing are performed according to standard techniques.

When the tibial bone structure shows signs of brittleness, leaving doubts as to the fixation resistance, or when the surgeon wants a guarantee fixation, a reinforcement accessory is used to ensure that the tibial joint (D2) does not slip into the tibial tunnel (T), nor the tendons that form the two bands (38).

In this case, (Fig.35) the excess tendon cut-out is not cut as in Fig. 33. A four-hole rectangular cortical support plate (12) is used through which the four ends of number 5 ethibonde wires (5) pass through. 15) which are attached to the hemisphere divider metal plate (16) of the tibial fixation device (D2). A triple knot (45) is then made in each pair of wires over the cortical support plate (12), as shown in figure 36. Thereby, the tibial device (D2) attaches to the support plate. cortical (12), which rests on the tibial cortex, prevents the migration of the joint into the tunnel. To complete the procedure (fig.37), the tendon tips that protrude out of the tunnel are sutured over the plate (12), as shown in the detail in figure 37, or if there is no tendon overhang, the cables ( C1 and C2) are tied over it, preventing proximal graft migration. Excess tendons or sutures are cut. Soon ,

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Afterwards, the surgical wound is closed and the surgical wound is dressed according to the usual techniques.

Should the fixation devices be removed, tendons, sutures will be cut and the four-hole rectangular plate removed (12), if used. Then, with the hexagon wrench (43), the dome expander screws (13) will be removed (11).

Then, the tibial puller (46) will be used, composed of a handle with an impact resistant quadrangular longitudinal bar (fig. 38), with holes coinciding with the two holes of the circular cover (14). Through the holes of the bar are introduced two puller pins (47), which will be screwed into the exit holes of the safety "ethibonde" (15). These pins are knurled at one end and have the self-tapping end at the other to initiate threading in the circular cap (14). The pull-out pin has a hexagonal recess in its head to accommodate the hexagonal wrench (43), which allows it to force the opening of its retaining thread through its self-tapping ends (48), as shown in figure 39. .

This extractor will be impacted with the hammer (35) in the opposite direction to the tibia (fig.40), in order to extract the tibial joint (D2) from inside the bone tunnel. The detail of Fig. 40 demonstrates the impact of the hammer (35) on the tibial puller (46), which extracts the tibial assembly (D2), through the puller pins (47).

For removal of the femoral joint (D1), the remains of the damaged grafts will be removed.

Through the new tibial tunnel, or through a joint access portal, a hexagon socket wrench (49) will be introduced to unscrew the femoral screw (2) until its inner face is more than 5mm back from the component capsule (3) femoral (D1) (fig.41). Then the hexagon socket wrench (49) is removed from the knee, and the femoral screw extractor (50) is introduced to grasp the inner face of the screw head (fig.42). The hex wrench (49) is then inserted, this time into the screw puller, engaging the screw head and puller cable to form a single screw-puller assembly, facilitating removal with rotation and pull in the withdrawal direction (fig.43). See detail in figure 43 of the screw fitted to the puller and the wrench. This prevents the screw from falling into the joint during its removal. Figure 44 shows the management of the femoral extraction key (49), the extractor (50) and details of its connection to the screw (2).

Thus, the completion of the graft removal procedure and its fixation devices is demonstrated.

References:

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Claims

1) "CURRIC-SPONY-COMPRESSIVE FIXING DEVICES FOR SINGLE-KNEE BANDING AND TL BI ALLEGAL FEMORAL TUNNEL AND RECONSTRUCTION SURGERY", characterized by compressive-spongy-o-compression devices (D1 and D2) device (D1) is used for femoral fixation and another device (D2) for tibial fixation.

2) "CURRICOUS-SPONY-COMPRESSIVE FIXING DEVICES FOR LINKING KNEE CONNECTION SURGERY WITH DOUBLE BAND AND FEMORAL AND TIBIAL TUNNELS" according to claim

1, characterized in that the first device (D1), ie the femoral fixation assembly (D2) is composed of a cork - spongy screw (2) coupled to a graft support base (3), which will also compress it. against the bone.

3) "CURRICOUS-SPONY-COMPRESSIVE FIXING DEVICES FOR LINKING KNEE CONNECTION SURGERY WITH DOUBLE BAND AND FEMORAL AND TIBIAL TUNNELS", according to claim

2, characterized by the flat-head hexagonal socket flat-head cortical-cancellous screw (2), with a proximal thread of variable length for cancellous tissue and a distal thread for cortical bone, about 4mm long wherein these two threads (R1 and R2) are discontinuous; screw (2) has a hole (7) in the tip for passage of "ethibonde" wires (8); This screw (2) has its length previously determined by the measuring procedure with the graduated ruler (9), and connects to the housing base (3) of the tendons (4).

4) "CORNAL-SPONY-COMPRESSIVE FIXING DEVICES FOR SINGLE KNEE BINDING CONNECTION SURGERY WITH SINGLE FEMALE AND TIBIAL TUNNELS" according to claim 2, characterized by the second device (D2) of the tibial two if composed hexagon socket head cap screws (13), one circular snap-on cap (14), two number 5 "ethibonde" wires (15) for safety fastening, one hemisphere divider metal plate (16) and two domes (11 ) semi-circular compression that work as bushings; the metal plate (16) has two protrusions (17) distal inclined ⁰ to 90 in order to fit accurately in the holes (18) of the semicircular dome (11).