Locking Compression Technology by aap

Transcription

1 Locking Compression Technology by aap

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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 Contents Introduction Material Description Indications / Contraindications Processing (Sterilization & Cleaning) Preoperative Planning Positioning Access Preparing the plate Placing K-wires Osteotomy Opening the osteotomy gap using a Lambotte chisel Checking, measuring and stabilizing the osteotomy gap Inserting the LOQTEQ High Tibia Osteotomy Plate Proximal plate fixation Compressing the lateral cortical bone (optional) Distal plate fixation Replacing the spacers and securing the remaining holes Replacing the standard screw by a locking cortical screw Radiological assessment Explantation Excursus Artosal (Reprobone ) wedges 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 corrective osteotomy of the tibial head is characteristic of joint-preserving corrections of tibial malpositions. Despite its short design, the LOQTEQ ensures stable fixation of open-wedge osteotomies and can therefore speed up postoperative mobilization through a smaller access and excellent angular stability. 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 anatomical 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 High stability thanks to four locking screws in the plate head Fitted targeting device guarantees a safe placement of drill guides at the preset angle High stability in the area of critical load thanks to an evenly rounded transition from head to shaft Symmetrical plate in one length 4.5 mm locking screws are applied to round locking holes The flattened end of the plate shaft enables the tissue-conserving, submuscular insertion of the plate 4

7 Introduction Indications/ Contraindications Indications Open-wedge osteotomies at the proximal medial tibia Treatment of bone and joint deformities Treatment of malpositions caused by injuries or disorders such as osteoarthritis Contraindications Inflammatory or rheumatoid arthritis Gonarthrosis involving more than one compartment Poor soft tissue condition at the medial head of tibia Infection or inflammation (local or systemic) Allergies against the implant material 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 under any circumstances (see Instructions for Use). 5

8 Preoperative Planning This surgical technique describes tibial head osteotomy using the example of the open-wedge method. Precise preoperative planning is essential for a successful procedure. This requires detailed knowledge of the anatomic and mechanical leg axes. For this purpose, take an image of the entire leg under load in AP view and proceed as follows: A A A A Mikulicz line C Fujisawa point e α α B D B D 1. Determine the mechanical 2. Determine the desired 3. Determine the center of 4. Connect the center of leg axis (Mikulicz line). weight-bearing line. From rotation (e) laterally, in the rotation with the preopera- For this purpose, draw a the center of the femoral proximal third of the tibio- tive endpoint (A) and the straight line from the center head (A), draw the line fibular joint but at least planned endpoint of the of the femoral head (A) to through the Fujisawa point 15 mm below the joint line. mechanical axis (D) and the middle of the talocrural (C) lateral to the preopera- determine the resulting joint (B). tive center of the knee angle. This angle (α) should joint (60%) to the postope- correspond to the open rative talocrural joint (D). wedge osteotomy. 6

9 Start the osteotomy immediately above the pes anserinus. Ensure that there is enough space to easily place all proximal screws and that they do not project into the osteotomy gap. 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 does not replace thorough planning and in-depth surgeon training on correcting axial malalignments. Positioning The patient is positioned supine on a radiolucent operating table. Ensure that the leg to receive surgery can be placed in 90 degree flexion and complete extension. The surgery is performed in approx. 20 flexion to protect neurovascular structures. To facilitate access to the medial aspect of the proximal tibia, extend the other leg and position it slightly lower. Intraoperatively, you must be able to easily extend the leg to check the leg axis. A tourniquet may be placed. Ensure that the head of femur and the ankle can be viewed under fluoroscopy. 7

10 Access INSTRUMENTS ART.-NO. Soft tissue retractor, radiolucent IU Slightly bend the leg. Place an incision just above the tibial tuberosity along the upper margin of the pes anserinus to the posteromedial edge of the medial tibial plateau. For access, perform the following steps: 1. Exposure of the pes anserinus and the superficial part of the medial collateral ligament. 2. Mobilization of the medial collateral ligament and release of the superficial part using a raspatory. 3. Insertion of the radiolucent soft tissue retractor between the medial collateral ligament and tibia. 4. Detachment of the periosteum along the planned osteotomy. This exposure (see figure) is important to determine precisely the course of the osteotomy. 8

11 Preparing the plate INSTRUMENTS ART.-NO. Angle Stable locking spacer LOQTEQ 4.5 IU Aiming device LOQTEQ HTO plate IU Screwdriver Duo, T25, quick coupling IU Fixing screw aiming device LOQTEQ LFI T25 IU Large handle, cannulated, quick coupling IU Screw the angle stable spacers (green) into the respective holes (see figure). The spacers are intended to prevent irritation of the pes anserinus. Install the aiming device on the plate using the fixing screw. A thread holds the fixing screw in the aiming device. For cleaning purposes, the screw must be screwed out of the aiming device. For this purpose, apply slight pressure onto the screw from the underside of the aiming device and remove the screw. 9

12 Placing K-wires INSTRUMENTS ART.-NO. K-wire with trocar point, ø2.5, L 200 NK Parallel drill guide for K-Wire, 2.5 IU Measuring device for K-Wire 2.5, L 200 IU Place the knee in 20 flexion and adjust the fluoroscope in such a way as to enable an AP view of the tibia. Under fluoroscopic monitoring, insert a K-wire ø2.5 into the head of tibia in accordance with the planned osteotomy. For this purpose, start over the pes anserinus, target the head of fibula and insert to the opposite cortical bone. Under fluoroscopic monitoring, check the position of the K-wire. If its positioning is not satisfactory, a second wire can be placed directly next to it and compared with the first one under fluoroscopic monitoring. Then remove the wrongly positioned K-wire. Ensure that enough space remains proximal to the osteotomy to place the screws. 10

13 Insert the parallel drill guide (IU ) over the K-wire to the bone and insert a second K-wire along the planned osteotomy. Under fluoroscopy, position the K-wires above one another. The sagittal inclination of the osteotomy should be parallel to the tibial plateau. To determine the cutting depth, measure the depth of the inserted K-wires using the measuring device for K-wires. Subtract 10 mm from the measured value for the opposite cortical bone. Mark the determined value on the saw blade (e.g. with sterile pen or Steri-Strip). In case of rotation correction or slope correction, parallel K-wires or Steinmann pins can be inserted into the proximal and distal fragments. 11

14 Osteotomy INSTRUMENTS ART.-NO. Soft tissue retractor, radiolucent IU Using an oscillating saw, start below the K-wires and saw to the marked depth along the K-wires. Ensure that the dorsal cortical bone is completely sawed through. Do not sever the tuberosity. After completing the transverse cut to the planned depth, perform the anterior cut using a thin saw blade. This cut is performed continuously from the medial through the lateral cortical bone. Depending on the osteotomy height and position of the patella (Caton index), it can be performed proximally or distally. Proceed slowly. Cool the saw blade using irrigation and ensure that the saw blade does not slip off. Avoid abrasion at the radiolucent soft tissue retractor. Proceed slowly when sawing. The sawing depth can be checked using fluoroscopy. 12

15 Opening the osteotomy gap using a Lambotte chisel INSTRUMENTS ART.-NO. Lambotte chisel, 25mm IU Using gentle mallet taps, carefully insert the first chisel to the lateral bridge along the transverse saw cut. The depth equals the sawed depth. Slowly insert the second chisel between the first chisel and the K-wires. The second chisel should be inserted less deep than the first one. N CAUTION: It is important to open the osteotomy slowly to avoid fracture of the lateral cortical bone. To further spread the osteotomy, a third chisel may be inserted between the first two chisels. Each additional chisel is inserted slowly and less deeply, until the desired osteotomy angle has been achieved. 13

16 Checking, measuring, and stabilizing the osteotomy gap INSTRUMENTS ART.-NO. Wedge gauge IU While spreading, continuously check the result on the basis of the preoperative plan. After removing the chisels, carefully exert valgus stress. To determine the gap s opening height and to maintain the opening, place the wedge gauge into the gap. If a neutral tibial slope is desired, the wedge gauge should be inserted dorsally. When inserting the wedge gauge, proceed carefully and if possible do not use mallet taps to avoid damaging the cortical bone. The base height of the osteotomy gap can be read off the wedge gauge; this height should equal the preoperatively determined height. If anterior K-wires or Steinmann pins have been used, they can also serve to check slope correction. Use fluoroscopic monitoring to check the gap with the leg extended, in two planes. Also note the tibial slope. 14

17 Inserting the LOQTEQ High Tibia Osteotomy Plate INSTRUMENTS ART.-NO. Aiming device LOQTEQ HTO plate IU Drill guide for round hole LOQTEQ 4.5, I-ø 3.9, blue IU Reduction sleeve for K-wire ø2.0 IU K-wire with trocar point, ø2.0, L 250 NK The wedge gauges keep the osteotomy gap open at the desired angle. Carefully remove the K-wires. Insert the prepared plate subcutaneously. The plate shaft should be approximately parallel to the tibial diaphysis. Position the plate in such a way that screws can be placed in all four proximal screw holes. The stabilizing part of the plate (without holes) must bridge the gap. Screw a drill guide (blue) into the central proximal hole and insert a reduction sleeve. Use a K-wire ø2.0 to temporarily fix in place the plate through the reduction sleeve and use fluoroscopy to check the fit of the plate as well as the course of the screws to be placed. 15

18 Proximal plate fixation INSTRUMENTS ART.-NO. Drill guide for round hole LOQTEQ 4.5, I-ø 3.9, blue IU Twist drill ø3.8, L 180, coil 50, quick coupling IU Depth gauge for locking screws, large IS Handle with quick coupling, with torque limiter, 3.5Nm IU Screwdriver Duo, T25, quick coupling IU Secure the round locking holes in the proximal portion of the plate using locking screws (blue). For this purpose, use the previously used threaded drill guide (blue) for round holes. The use of the screwdriver duo can facilitate the insertion and later removal of the threaded drill guide. Drill to the desired depth using a drill bit ø3.8 (red-blue) for locking screws without penetrating the opposite cortical bone. Determine the drilling depth using the depth gauge and tighten a locking screw (blue) of the appropriate length using the screwdriver T25 and the handle with torque limiter. We recommend using screws of maximum possible length. However, ensure that the lateral cortical bone is not penetrated. We recommend tightening the screws using the torque limiter. Optimal fixation is reached once an audible click is heard. Secure all 3 proximal plate holes in this way. 16

19 Compressing the lateral cortical bone (optional) INSTRUMENTS ART.-NO. Drill guide for round hole LOQTEQ 4.5, I-ø 3.9, blue IU Twist drill ø3.2, L 195, coil 50, quick coupling IU Depth gauge for locking screws, large IS Screwdriver, hexagonal, ø3.5 for quick coupling IU Large handle, cannulated, quick coupling IU In the first shaft hole below the osteotomy, the plate can be pulled to the bone by a standard screw. For this purpose, screw the threaded drill guide (blue) for round holes into the hole. The use of the screwdriver duo can facilitate the insertion and later removal of the threaded drill guide. Drill to the desired depth using a drill bit ø3.2 for standard screws. Determine the drill depth using the depth gauge and tighten a standard screw of appropriate length using the hexagonal screwdriver. By tightening the screw, the plate is elastically bent. This means that it is closer to the bone and creates a spring effect that causes compressive stress on the lateral cortical bone. 17

20 Distal plate fixation INSTRUMENTS ART.-NO. Drill guide for round hole LOQTEQ 4.5, I-ø 3.9, blue IU Twist drill ø3.8, L 180, coil 50, quick coupling IU Depth gauge for locking screws, large IS Large handle, cannulated, quick coupling IU Handle with quick coupling, with torque limiter, 3.5Nm IU Screwdriver Duo, T25, quick coupling IU Apply a locking screw to the penultimate hole in the distal part of the plate. For this purpose, screw the threaded drill guide (blue) for round holes into the hole. The use of the screwdriver duo can facilitate the insertion and later removal of the threaded drill guide. Drill bicortically to the desired depth using a drill bit ø3.8 (redblue) for locking screws. Determine the drilling depth using the depth gauge and tighten a locking screw (blue) of the appropriate length using the screwdriver T25 and the handle with torque limiter. We recommend tightening the screws using the torque limiter. Optimal fixation is reached once an audible click is heard. 18

21 Replacing the spacers and securing the remaining holes INSTRUMENTS ART.-NO. Drill guide for round hole LOQTEQ 4.5, I-ø 3.9, blue IU Twist drill ø3.8, L 180, coil 50, quick coupling IU Depth gauge for locking screws, large IS Screwdriver Duo, T25, quick coupling IU Handle with quick coupling, with torque limiter, 3.5Nm IU Remove the spacer from the distal hole and replace it by a locking screw. For this purpose, screw the threaded drill guide (blue) for round holes into the hole. Drill to the desired depth bicortically or monocortically using a drill bit ø3.8 (red-blue) for locking screws. Determine the drilling depth using the depth gauge and tighten a locking screw (blue) of appropriate length using the screwdriver T25 and the handle with torque limiter. We recommend tightening the screws using the torque limiter. Optimal fixation is reached once an audible click is heard. After removing the distal spacer, remove the proximal spacer and replace it by a locking screw. For this purpose, screw the threaded drill guide (blue) for round holes into the hole. Drill to the desired depth using a drill bit ø3.8 (red-blue) for locking screws. Determine the drilling depth using the depth gauge and tighten a locking screw (blue) of the appropriate length using the screwdriver T25 and the handle with torque limiter. We recommend that you use a screw of maximum possible length. However, ensure that the lateral cortical bone is not penetrated. 19

22 Replacing the standard screw by a locking cortical screw INSTRUMENTS ART.-NO. Drill guide for round hole LOQTEQ 4.5, I-ø 3.9, blue IU Twist drill ø3.8, L 180, coil 50, quick coupling IU Depth gauge for locking screws, large IS Handle with quick coupling, with torque limiter, 3.5Nm IU Screwdriver Duo, T25, quick coupling IU Finally, remove the previously placed standard screw from the hole below the osteotomy gap and replace it by a locking screw. Bicortically tighten the locking screw. You must drill again using a drill bit ø3.8 and the drill guide. We recommend tightening the screws using the torque limiter. Optimal fixation is reached once an audible click is heard. 20

23 Radiological assessment View the position of the plate and the correction results in two planes under fluoroscopy. If the result is satisfactory, close the wound. Explantation INSTRUMENTS ART.-NO. Screwdriver, T25, Round Handle IU The screwdrivers in the set (T25) 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 using the old scar. After manually loosening the screws, removal can be performed in automated mode in a second step. 21

24 Excursus - Artosal (Reprobone ) wedges With years of experience in the development and manufacture of biomaterials for traumatology, orthopedics and spine surgery, aap offers optimally harmonized product combinations for various indications. For better and more stable fracture healing, aap recommends complete defect filling using bone substitute in addition to the employed osteosynthesis. Artosal is the optimal product for use in corrective osteotomies, particularly thanks to its special wedge shape and its hydroxyapatite (HA) and β-tricalcium phosphate (β-tcp) composition. Artosal is a fully synthetic osteoconductive bone substitute for the reconstruction of aseptic bone defects and exhibits controlled resorption. With its ultra-porous and highly interconnected pore matrix, Artosal offers a similar strength as human cancellous bone and supports the formation of the new natural bone. Artosal can be first coated with patient material to improve osseointegration. Advantages Osteoconductive and completely biocompatible Very similar to the mineral component of human bone, with a composition of 60% hydroxyapatite (HA) and 40% β-tricalcium phosphate (β-tcp) Ultraporous with pore sizes of μm (average μm) Interconnecting pore matrix is very similar to human cancellous bone and particularly supports rapid and unlimited bone ingrowth Microporosity allows nutrient supply to the new bone Controlled resorbability after 1-2 years By products of absorption support osteoblast formation and ingrowth Good adaptation to the defect size using existing surgical instruments 22

25 Completely reproducible manufacture reduces or replaces the need for autologous material Can be mixed with autologous material for additional enrichment with patient growth factors More than 25 years of successful clinical results for material combinations of HA and TCP Osteoconductivity shown under fluoroscopy through the pores in the direction of the implant center SIZE ANGLE ART.-NO. 20 x 25 x 8 x x 25 x 10 x x 25 x 12 x x 25 x 14 x x 35 x 8 x x 35 x 10 x x 35 x 12 x x 35 x 14 x

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27 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 PO LOQTEQ Distal Femur Osteotomy Plate 4.5, R PO LOQTEQ Distal Femur Osteotomy Plate 4.5, L PO AVALABLE ON REQUEST Srewdriver mini, SW 2.5 IU * available in

28 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

29 Trays 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

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31 Subject to technical modifications, errors and misprints. WP 2OP80 EN / 1405 Layout, type: design graphic - Wolfram Passlack Illustrations: Karen Hilberg Lorenzweg Berlin Germany Phone Fax customer.service@aap.de

32 Lorenzweg Berlin Germany Phone Fax customer.service@aap.de WP 2OP080 EN / 1405