Locking Compression Technology by aap

Transcription

1 Locking Compression Technology by aap

2 Dear User, The following operational manual describes the surgical steps regarding the implantation of the aap distal femur osteotomy plate. At this stage it is important to mention that the angle gauge for closed wedge osteotomy (IU ) is designed to intraoperatively support the surgeon with the correct placement of the 2.5 mm K-Wires in the pre operatively planned angle (p. 10 & 11). Nevertheless after years of successful implantation of similar plates without this type of instrument (IU ), it is considered an optional tool. The procedure can be performed by an experienced surgeon anytime without this device. The following steps without the angle gauge can be considered standard technique: The 2.5 mm K-Wire is aimed at the hinge point of the lateral cortical bone using fluroscopy. The target point is slightly proximal to the lateral femoral condyle, as specified in the preoperative planning. Insert the K-Wire as far as the contra cortical bone. By choice, a second parallel K-Wire can be placed using the parallel drill guide. (compare p. 9) 1 2 A second K-Wire is now inserted in an angle aiming with the tip of the K-Wire towards the same hinge point. With a steril ruler or measuring strip make sure that the distance (wedge height) matches the requirements measured in the preoperative planning. (fig. 2 & 3). Check these steps using fluroscopy (compare x-rays below). After correct placement of the K-Wires, use oszillating saw to cut out the wedge between the two K-Wires. 3 4 Remove bone wedge in between the K-Wires and close the gap (compare x-rays below). Ensure that during saw usage the lateral cortical bone is kept intact. As a reference the osteotomy should end approximately 10 mm from the lateral cortical bone. Continue on page 12 of this operational manual Developing surgeon reference, with kind support of Prof. Dr. Wolf Petersen:»Operative Orthopädie und Traumatologie, December 2013, Volume 25, Issue 6 pp Osteotomie am distalen Femur zur Korrektur von Genu valgum und Torsionsfehlern, Prof. Dr. W. Petersen, P. Forkel«

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4 Disclaimer This surgical technique is exclusively intended for medical professionals, especially physicians, and therefore may not be regarded as a source of information for non-medical persons. The description of this surgical technique does not constitute medical advice or medical recommendations nor does it convey any diagnostic or therapeutic information on individual cases. Therefore, the attending physician is fully responsible for providing medical advice to the patient and obtaining the informed consent of the patient which this surgical technique does not supersede. The description of this surgical technique has been compiled by medical experts and trained staff of aap Implantate AG with utmost diligence and to the best of their knowledge. However, excludes any liability for the completeness, accuracy, currentness, and quality of the information as well as for material or immaterial damages arising from the use of this information. 2

5 Content Introduction Material Description Indications / Contraindications Processing (Sterilization & Cleaning) Preoperative Planning Positioning Access Preparing the plate Placing K-wires Osteotomy Inserting the LOQTEQ Distal Femur Osteotomy Plate Distal plate fixation Compression of the osteotomy with a LOQTEQ locking screw (red) Proximal plate fixation Radiological assessment Postoperative treatment Explantation Trays LOQTEQ Osteotomy Set, HTO/DFO

6 Introduction The LOQTEQ is part of the LOQTEQ portfolio and unifies angular stability with modern plate design. The purpose of supracondylar femoral varus osteotomy is to correct the axis of the genu valgum in order to reduce the stress on the lateral joint compartment, thereby counteracting the progress of degenerative joint disease. The standard methods for corrective varus osteotomy are the lateral open-wedge technique or the medial closed-wedge technique. The method described here is state of the art and demonstrates the special features of the LOQTEQ using the (femoral) closed-wedge method. The LOQTEQ guarantees stable fixation of the correction. The unique feature of LOQTEQ locking compression allows the plate to compress and maintain the required closed wedge osteotomy without any great effort. Material For the manufacture of angle stable plate systems materials are used which have been proven to be successful in medical technology for decades. The osteotomy plates and bone screws are made of titanium alloy. All materials employed comply with national and international standards. They are characterized by good biocompatibility, a high degree of safety against allergic reactions and good mechanical properties. Description 4.5 mm locking screws optimally aligned for the stable fixation in bone Anatomical shape available as right and left version LOQTEQ technology for locking compression in closed-wedge osteotomy The flattened end of the plate shaft enables the tissue-conserving, submuscular insertion of the plate Fitted targeting device guarantees a safe placement of drill guides at the preset angle 4

7 Introduction Indications/ Contraindications Indications Closed-wedge osteotomies of the medial distal femur Treatment of bone and joint deformities Treatment of malpositions caused by injuries or disorders such as osteoarthritis Contraindications Inflammatory or rheumatoid arthritis Grade III or IV chondrosis of the medial compartment of the knee joint Total medial meniscectomy Gonarthrosis involving more than one compartment Poor soft tissue condition at the distal femur Infection or inflammation (local or systemic) Allergies against the implant material Acute or chronic osteomyelitis at or close to the surgical field High risk patients for anesthesia Severe soft tissue swelling impacting normal wound healing Fractures in children and adolescents with epiphyseal plates not yet ossified Processing (Sterilization & Cleaning) The implants are supplied sterile and non-sterile. Implants and instruments that are supplied in non-sterile condition must be sterilized before use. For this purpose, please refer to the Instructions for Use that are enclosed with the plates, instruments and trays. Do not use (sterile) implants from damaged or open inner packaging. Implant components that have come or might have come into contact with infectious fluids (e.g. blood) must not be resterilized and reused in another surgery. They must be returned to the manufacturer. Resterilization is prohibited in this case (see Instructions for Use). 5

8 Preoperative Planning This surgical technique describes the distal femoral varization osteotomy using the example of the closed-wedge method. Precise preoperative planning is essential for a successful procedure. This requires detailed knowledge of the anatomical and mechanical axes of the lower limb. For this purpose, take a weight-bearing X-ray of the entire leg in AP view and proceed as follows: C α D B A B A 1. Determine the mechanical leg axis. For this purpose, draw a straight line from the center of the femoral head to the middle of the ankle joint (A). 2. Determine the postoperative weight-bearing line. Draw a line from the center of femoral head to the desired point medial to the center of the preoperative knee join (B). 3. Draw a line from the middle of the upper ankle joint (A) through the center of the knee joint, ending at point C. 4. Position (D) is the rotation or hinge point of the osteotomy. The chosen position is slightly above the lateral condyle. 5. Angle alpha (α) corresponds to the angle of the osteotomy. 6

9 The osteotomy should not be parallel to the joint line, because this may form a step-off in the bone. To guarantee optimum cortical support and the resulting stability, the incision should run diagonally from the medial metaphysis towards the lateral condyle to position (D) (see Figure). Conventional planning software can very clearly demonstrate the exact correction angles, incision depth of the osteotomy, and the resulting height of the osteotomy. Planning software cannot replace thorough planning by, and the experience of, the surgeon in working with procedures for correcting axial malalignments. Positioning The patient is positioned supine on a radiolucent operating table. Position the contralateral leg slightly lower and straight for easier access to the medial aspect of the distal femur. A tourniquet may be placed. N RECOMMENDATION: Before making an incision, perform arthroscopy to once again confirm the indication for surgery and to address any minor intra-articular damage. Access INSTRUMENTS ART.-NO. Soft tissue retractor, radiolucent IU Make an anteromedial longitudinal incision with the knee joint fully extended. Start the approx. 10 cm incision above the patella and continue cranially along the femur. Release the fascia of vastus lateralis and lift the muscle ventrally. Position the radiolucent soft-tissue retractor dorsal to the shaft of the femur. It must be exposed sufficiently to allow secure placement of the plate. The incision can be reopened for potential subsequent operations, such as a total knee replacement. 7

10 Preparing the plate INSTRUMENTS ART.-NO. Aiming device LOQTEQ DFO Plate, R / L IU x Screwdriver Duo, T25, quick coupling IU Fixing screw aiming device LOQTEQ LFI T25 IU Mount the targeting device on the plate using the fixing screw. A thread holds the fixing screw in the targeting device. For cleaning purposes, the screw must be screwed out of the targeting device. For this purpose, apply slight pressure onto the screw from the underside of the targeting device, unscrew and remove the screw. Placing K-wires INSTRUMENTS ART.-NO. K-wire with trocar point, ø 2.5, L 200 NK Measuring device for K-Wire 2.5, L 200 IU Parallel drill guide for K-Wire, ø 2.5 IU Extend the leg fully and position it to enable an AP view of the femur under fluoroscopy. Placement of the plate assists with determining the position of the osteotomy and the height of the first K-wire on the medial aspect. 8

11 The 2.5 mm K-wire is aimed at the hinge point of the lateral cortical bone under fluoroscopy, similar to the technique used with the HTO. The target point is slightly proximal to the lateral femoral condyle, as specified in the preoperative planning. Insert the K-wire as far as the contra cortical bone. Thread the parallel drill guide over the K-wire. A second K-wire is placed parallel to the first with the aid of the parallel drill guide. The K-wires mark the caudal osteotomy. The insertion depth of the K-wires is measured with the direct measuring device. Approximately 10 mm must be subtracted from the measured value to ensure that the contra cortical bone remains intact during sawing. 9

12 Osteotomy Place an oscillating saw superior to the K-wires and saw down to the calculated depth along the K-wires. Ensure that the posterior medial cortical bone is completely sawed through. Use the aap radiolucent soft-tissue retractor to protect dorsal soft tissues. If the angle gauge for closed-wedge osteotomy is used, the K-wires can be removed after completion of the saw cut. Proceed slowly. Irrigate the saw blade to cool it and make sure that the blade does not slip. Preparation of the angle gauge for closed-wedge osteotomy INSTRUMENTS ART.-NO. Angle gauge for closed wedge osteotomy IU Loosen the nut above gauge arm to allow the gauge arm to move freely. Set the correction angle calculated in preoperative planning on the angle scale by pivoting the angular arm. Pivot it until the desired value is above the arrow. Then lock the angular arm with the nut. 10

13 Push the angle gauge into the previously sawn incision as far as the lateral cortical bone. Align the gauge arm parallel to the femoral shaft. The angle gauge can be secured with a 2.0 mm K-wire to prevent rotation. Insert two 2.5 mm K-wires through the K-wire guide on the angular arm. To release the angle gauge, first loosen the nut and then remove the entire angle gauge. Place an oscillating saw inferior to the K-wires and saw down to the calculated depth along the K-wires. Ensure that the posterior medial cortical bone is completely sawed through. Use the aap radiolucent soft-tissue retractor to protect dorsal soft tissues. Primary stability is particularly important for closed-wedge osteotomy. This requires ensuring full cortical contact after closing the osteotomy gap. An isosceles triangle-shaped wedge of bone measured with the angle gauge is sawn out as one piece of bone. 11

14 On completion of the transverse cuts to the planned depth, the anterior cut is performed with a thin saw blade. This cut is continuous from the medial to the lateral cortical bone. For a better osteotomy result, the biplanar cut is recommended. Proceed slowly. Irrigate the saw blade to cool it and make sure that the blade does not slip. Once the wedge has been sawn out and removed, the osteotomy gap is closed and compressed and held by manual pressure. The leg correction is now checked against the preoperative drawings and can be verified with X-ray and an alignment rod. The bone wedge have to be removed completely otherwise the osteotomy might not close. 12

15 Inserting the LOQTEQ Distal Femur Osteotomy Plate INSTRUMENTS ART.-NO. Aiming device LOQTEQ DFO Plate IU 8185-xx Drill guide for round hole LOQTEQ 4.5, I-ø 3.9, blue IU Reduction sleeve for K-wire ø 2.0 IU K-wire with trocar point, ø 2.0, L 250 NK After closing the osteotomy, the plate is inserted so the distal section is correctly placed on the medial condyle and the proximal section follows the shaft. K-wires can be used for temporary fixation of the plate and to check the subsequent screw positions. Insert a drill guide (blue) into one of the distal holes through the targeting device, insert the reduction sleeve, and insert a 2.0 mm K-wire through the reduction sleeve. Then check the AP and ML position of the plate under fluoroscopy. Insert the K-wire through to the contra cortical bone, but be careful not to penetrate the lateral cortical bone. Check the position of the plate and the subsequent screw and correct if necessary. 13

16 Distal plate fixation INSTRUMENTS ART.-NO. Drill guide for round hole LOQTEQ 4.5, I-ø 3.9, blue IU Twist drill ø 3.8, L 180, coil 50, quick coupling IU Depth gauge for locking screws, large IS Handle with quick coupling, with torque limiter 3.5 Nm IU Screwdriver Duo, T25, quick coupling IU Insert locking screws (blue) into the round locking holes in the distal part of the plate. Use the previously used drill guide (blue) for round holes. Use of the screwdriver duo may facilitate screwing or subsequent unscrewing of the threaded drill guide. Drill to the desired depth using a drill bit ø3.8 (red / blue) for locking screws. The drill depth can be read directly from the laser mark on the drill or measured with the depth gauge after removing the drill guide. 14

17 We recommend that you use a screw of maximum possible length. However, ensure that the lateral cortical bone is not penetrated. As soon as the head of the screw reaches the plate hole it is compulsory to switch to the torque limiter. Optimal fixation is reached once an audible click is heard. Secure all four distal plate holes in this way. Then remove the targeting device. The position of the screws should be reviewed in AP and ML using fluoroscopy. 15

18 Compression of the osteotomy with a LOQTEQ locking screw INSTRUMENTS ART.-NO. Basic insert for load drill guide, LOQTEQ 4.5, round hole IU Load drill guide LOQTEQ 4.5, adjustable up to 2 mm IU Twist drill ø 3.8, L 180, coil 50, quick coupling IU Depth gauge for locking screws, large IS Handle with quick coupling, with torque limiter 3.5 Nm IU Screwdriver Duo, T25, quick coupling IU Drill guide for gliding hole LOQTEQ 4.5, I-ø 3.9, red IU Screw the basic insert for load drill guide into the first distal shaft hole. This holds the load drill guide to allow drilling in the correct alignment and to reach the required compression. The adjustment wheel of the variable load drill guide is rotated to the required compression to a maximum of 2.3 mm (see Figure). 1 If the compression is too high, it may not be possible to countersink the screw completely. Drill to the desired depth monocortically using the drill bit ø3.8 (red / blue). Monocortical compression is possible with the locking screw (red) for gliding locking hole and it offers sufficient stability for closed-wedge osteotomy. 16

19 After removal of the basic insert and load drill guide, a LOQTEQ locking screw (red) of the appropriate length is inserted. As soon as the head of the screw reaches the plate hole it is compulsory to switch to the torque limiter. Optimal fixation is reached once an audible click is heard. In cases of very hard bone in the diaphysis it is necessary to make sure that the screw head is flush to the plate. Therefore it is permissible in exceptionally hard bone of the diaphysis to finish the screw without the torque limiter. After compression it is advisable to review the leg axis under fluoroscopy. If compression is not to be used, close the load drill guide and drill the pilot hole in neutral position. 17

20 Proximal plate fixation INSTRUMENTS ART.-NO. Drill guide for round hole LOQTEQ 4.5, I-ø 3.9, blue IU Screwdriver Duo, T25, quick coupling IU Twist drill ø 3.8, L 180, coil 50, quick coupling IU Depth gauge for locking screws, large IS Handle with quick coupling, with torque limiter 3.5 Nm IU After compression with the red locking screw, the remaining shaft holes are completed with locking screws (blue) for round holes. Proceed from distal to proximal. The basic insert for load drill guide in the most distal hole is replaced by a drill guide for round holes (blue). Drill bicortically to the desired depth using the drill bit ø3.8 (red / blue). The drill depth can be read directly from the laser mark on the drill or measured with the depth gauge after removing the drill guide. 18

21 The screws can be inserted using a power screwdriver. However, switch to manual screwing before the screw head reaches the plate. As soon as the head of the screw reaches the plate hole it is compulsory to switch to the torque limiter. Optimal fixation is reached once an audible click is heard. In cases of very hard bone in the diaphysis it is necessary to make sure that the screw head is flush to the plate. Therefore it is permissible in exceptionally hard bone of the diaphysis to finish the screw without the torque limiter. Locking screws (blue) for round holes are placed in the remaining two holes in the same way. Either monocortical or bicortical. 19

22 Radiological assessment View the position of the plate and the correction results in two planes using fluoroscopy. If the result is satisfactory, close the wound after irrigation. Postoperative treatment X-ray examination postoperative, after 6 and 12 weeks Removal of sutures after 12 days kg partial weight bearing for 6 weeks After 7 weeks pain-adapted full weight bearing If the osteotomy is visible after 6 weeks, partial weight bearing should be continued for a further 3-4 weeks Manual lymphatic drainage for any lymphedema Electrical muscle stimulation to strengthen vastus medialis Explantation INSTRUMENTS ART.-NO. Screwdriver, T25, Round Handle IU Screwdriver, hexagonal, ø3.5 IU The screwdrivers (T25) in the set are self-retaining. To achieve maximum torque during screw removal, we recommend using the appropriate explantation screwdriver (IU ). It allows deeper penetration into the screw head and hence safe screw removal. It can be ordered separately. The implant should be removed only after complete healing of the osteotomy. Place an incision on the old scar. After manually loosening the screws, the removal can be performed in automated mode in a second step. 20

23 Trays LOQTEQ Osteotomy Set, HTO/DFO IC ARTICLE ART.-NO. Tray for instruments, LOQTEQ Osteotomy, empty IC Screw rack for extension set LOQTEQ Osteotomy, empty IC Lid for trays, large IC Depth gauge for locking screws, large IS Lambotte chisel, 25 mm IU Twist drill ø 3.2, L 195, coil 50, quick coupling IU Twist drill ø 3.8, L 180, coil 50, quick coupling IU Large handle, cannulated, quick coupling IU Handle with quick coupling, with torque limiter 3.5 Nm IU Screwdriver, hexagonal, ø 3.5 for quick coupling IU Screwdriver Duo, T25, quick coupling IU Measuring device for K-Wire 2.5, L 200 IU Wedge gauge IU Angle gauge for closed wedge osteotomy IU * Soft tissue retractor, radiolucent IU Load drill guide LOQTEQ 4.5, adjustable up to 2 mm IU Reduction sleeve for K-wire ø 2.0 IU Drill guide for round hole LOQTEQ 4.5, I-ø 3.9, blue IU Basic insert for load drill guide, LOQTEQ 4.5, round hole IU Fixing screw aiming device LOQTEQ LFI T25 IU Aiming device LOQTEQ HTO Plate IU Aiming device LOQTEQ DFO Plate, R IU Aiming device LOQTEQ DFO Plate, L IU Parallel drill guide for K-Wire, ø 2.5 IU K-wire with trocar point, ø 2.0, L 250 NK K-wire with trocar point, ø 2.5, L 200 NK LOQTEQ High Tibia Osteotomy Plate 4.5 PO LOQTEQ, R PO LOQTEQ, L PO AVALABLE ON REQUEST Srewdriver mini, SW 2.5 IU * available in

24 Trays LOQTEQ Osteotomy, Screw Rack, complete ARTICLE ART.-NO. Screw rack for extension set LOQTEQ Osteotomy, empty IC Angle Stable locking spacer LOQTEQ 4.5 IU Standard screws with small head 4.5 Titanium ARTICLE ART.-NO. Cortical Screw 4.5, small head, self-tapping, L 22 SK Cortical Screw 4.5, small head, self-tapping, L 24 SK Cortical Screw 4.5, small head, self-tapping, L 26 SK Cortical Screw 4.5, small head, self-tapping, L 28 SK Cortical Screw 4.5, small head, self-tapping, L 30 SK Cortical Screw 4.5, small head, self-tapping, L 32 SK Cortical Screw 4.5, small head, self-tapping, L 34 SK Cortical Screw 4.5, small head, self-tapping, L 36 SK

25 Trays Screws for gliding locking hole 4.5 Titanium ARTICLE ART.-NO. LOQTEQ Cortical Screw 4.5, T25, self-tapping, L 18 SK LOQTEQ Cortical Screw 4.5, T25, self-tapping, L 20 SK LOQTEQ Cortical Screw 4.5, T25, self-tapping, L 22 SK LOQTEQ Cortical Screw 4.5, T25, self-tapping, L 24 SK Screws for round locking hole 4.5 Titanium ARTICLE ART.-NO. LOQTEQ Cortical Screw 4.5, small head T25, self-tapp. L 18 SK LOQTEQ Cortical Screw 4.5, small head T25, self-tapp. L 20 SK LOQTEQ Cortical Screw 4.5, small head T25, self-tapp. L 22 SK LOQTEQ Cortical Screw 4.5, small head T25, self-tapp. L 24 SK LOQTEQ Cortical Screw 4.5, small head T25, self-tapp. L 26 SK LOQTEQ Cortical Screw 4.5, small head T25, self-tapp. L 28 SK LOQTEQ Cortical Screw 4.5, small head T25, self-tapp. L 30 SK LOQTEQ Cortical Screw 4.5, small head T25, self-tapp. L 32 SK LOQTEQ Cortical Screw 4.5, small head T25, self-tapp. L 34 SK LOQTEQ Cortical Screw 4.5, small head T25, self-tapp. L 36 SK LOQTEQ Cortical Screw 4.5, small head T25, self-tapp. L 38 SK LOQTEQ Cortical Screw 4.5, small head T25, self-tapp. L 40 SK LOQTEQ Cortical Screw 4.5, small head T25, self-tapp. L 42 SK LOQTEQ Cortical Screw 4.5, small head T25, self-tapp. L 45 SK LOQTEQ Cortical Screw 4.5, small head T25, self-tapp. L 50 SK LOQTEQ Cortical Screw 4.5, small head T25, self-tapp. L 55 SK LOQTEQ Cortical Screw 4.5, small head T25, self-tapp. L 60 SK LOQTEQ Cortical Screw 4.5, small head T25, self-tapp. L 65 SK LOQTEQ Cortical Screw 4.5, small head T25, self-tapp. L 70 SK LOQTEQ Cortical Screw 4.5, small head T25, self-tapp. L 75 SK LOQTEQ Cortical Screw 4.5, small head T25, self-tapp. L 80 SK LOQTEQ Cortical Screw 4.5, small head T25, self-tapp. L 85 SK

26 24 Notice

27 Subject to technical modifications, errors and misprints. WP 2OP070 EN / 1405 Layout, type: design graphic - Wolfram Passlack Illustrations: Karen Hilberg Lorenzweg Berlin Germany Phone Fax customer.service@aap.de

28 Lorenzweg Berlin Germany Phone Fax customer.service@aap.de WP 2OP070 EN / 1405