Locking Compression Technology by aap

Transcription

1 Minimally Invasive Locking Compression Technology by aap

2

3 Minimally Invasive 1

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 Materials Description Indications / Contraindications Processing (Sterilization & Cleaning) Preoperative Planning Positioning Access Summary of surgical steps Repositioning Attachment of the targeting device to the plate Insertion of the plate Connection of targeting frame to handle Placement of proximal stabilization bolt Note on correct securing of the holes Temporary fixation with K-wires Insertion of screws in the head of the plate Insertion of screws in the shaft of the plate Placement of periprosthetic screws Compression of a shaft fracture Explantation Trays LOQTEQ Distal Lateral Femur Plate, Complete Set LOQTEQ Distal Lateral Femur Plate, Set of Instruments, Tray A LOQTEQ Distal Lateral Femur Plate, Set of Instruments, Tray B LOQTEQ Distal Lateral Femur Plate, Set of Implants, Tray C LOQTEQ Distal Lateral Femur Plate, Screw Rack, complete

6 Introduction The distal lateral femur plate 4.5 is part of the LOQTEQ anatomical plating system and unifies angular stability with modern plate design. Materials 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 reliability against allergic reactions and good mechanical properties. Description The distal plate contour is adapted to the anatomy of the lateral condyle of the distal femur The plate design follows the natural ante curvature of the femur A high shaft profile without undercuts guarantees excellent stability The flattened end of the plate shaft enables the tissue-conserving, submuscular insertion of the plate Periprosthetic screws in various lengths allow monocortical fixation in the presence of an intramedullary implant The targeting device made of radiolucent material facilitates minimally invasive application, so that the patient can be mobilized at an early time Gliding-locking holes in the shaft area enable further compression Various holes for K-wires and an oblong hole facilitate the primary fixation of the plate Available as right and left version Standard sizes include 4-17 holes in the plate shaft 4

7 Introduction Indications/ Contraindications Indications The distal lateral femur plate 4.5 mm is indicated for stabilizing: Intra- and extra-articular fractures Non-unions Periprosthetic fractures Corrections of distal femoral fractures healed in malposition Distal diaphyseal fractures of the femur Contraindications Infection or inflammation (localized or systemic) Allergies against the implant material Acute or chronic osteomyelitis at or close to the surgical field High anesthesia risk patients Severe soft tissue swelling impacting normal wound healing of surgical incisions Insufficient soft tissue coverage Fractures in children and adolescents with epiphyseal plates not yet ossified Processing (Sterilization & Cleaning) Instruments and implants are supplied non-sterile. Before every use, instruments as well as implants must be processed. Reference is here made to the Instructions for Use. Implant components which may 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 Evaluate the fracture situation and select the appropriate plate position and screw length on the basis of X-ray. Also plan the insertion of lag screws, if necessary. Positioning Position patient in supine position on a radiolucent operating table. The patient s leg must be freely moveable in such a way that the knee can be flexed and lateral X-rays of the leg can be taken. Access Incision of 6-10 cm, depending on soft tissue situation. The distal lateral femur plate can be placed through the small incision between the periosteum and the vastus lateralis. Anterolateral arthrotomy is recommended for intra-articular fractures. 6

9 Summary of Surgical Steps Attach the targeting device to the plate (affix the stabilization bolt and fixing nut to the plate through the central hole A) Insert of the plate in the patient Connect of targeting frame to handle 4 5 Proximal stabilization bolt (blue drill guide for the outermost proximal round hole to stabilize the frame) Temporary fixation with K-wires 6 Insert the screws at the Femoral Joint (blue drill guides, drill, measure screws) Insert screws in automated mode only until yellow marking, then use torque limiter by hand 7 Insert the screws at the diaphysis (red drill guides, drill, measure screws) insert screws in automated mode until black marking, then, use torque limiter by hand 8 If necessary, perform open surgery to compress using LOQTEQ screws (open large fragment instrument tray/4.5 basic tray) 7

10 Repositioning Reduce fracture fragments and/or joint surface and temporarily fix in place with K-wires. When applying temporary fixation with K- wires, consider the later position of the plate. If necessary, use lag screws applied outside of the late plate position to compress the fracture. Check the reduction results using fluoroscopy. N NOTE: Please ensure that outer lag screws do not interfere with the plate screws. É N CAUTION: The LOQTEQ distal lateral femur plate is meant to be used only in combination with standard screws and angular stable LOQTEQ locking screws (red). Please do not use the blue screws for round holes for this plate. 8

11 Attachment of the targeting device to the plate INSTRUMENTS ART.-NO. Handle for targeting frame LOQTEQ DF 4.5, right IU Handle for targeting frame LOQTEQ DF 4.5, left IU Stabilization bolt for targeting frame LOQTEQ DF 4.5 IU Fixing nut for stabilization bolt IU Drill guide for round hole LOQTEQ 4.5, I-ø 4.2, blue, long IU Screwdriver Duo long, T25, quick coupling IU Handle for quick coupling, large, cannulated IU Interlock the handle with the distal part of the plate. Insert the stabilization bolt with the already attached fixing nut into hole A of the handle and screw to the plate. Then tighten the fixing nut against the handle. Additional stabilization can be achieved through hole G using the drill guide for round holes (blue). The use of the screwdriver duo may help with screwing/unscrewing of the drill guide. 9

12 Insertion of the plate INSTRUMENTS ART.-NO. Raspatory, long curved IU To slide in the plate, create a tunnel between the vastus lateralis and periosteum using the raspatory. Do not lift the periosteum off the bone in the process. Insert the plate, sliding the proximal end along the bone until the distal end of the plate rests properly at the lateral condyle. 10

13 Connection of targeting frame to handle INSTRUMENTS ART.-NO. Targeting frame LOQTEQ DF 4.5, R/L IU 8175-x1 Insert targeting frame into the lateral recesses of the handle and press down. p p N NOTE: Ensure that no gap remains between the targeting frame and the handle. 11

14 Placement of the proximal stabilization bolt INSTRUMENTS ART.-NO. Tissue protection sleeve LOQTEQ DF 4.5, long IU Trocar, LOQTEQ DF 4.5 IU Drill guide for round hole LOQTEQ 4.5, I-ø 4.2, blue, long IU Tissue spreader IU Insert the tissue protection sleeve with screwed-in trocar into the most proximal plate hole and guide to the plate via a stab incision. Check the proximal position of the plate by palpation or fluoroscopy. p p Replace the trocar by the drill guide for round holes (blue) and screw into the plate hole. N NOTE: For better visualization and secure fixation of the most proximal plate hole, it is suggested to follow a semi-invasiv approach using the tissue spreader (s. picture). N NOTE: To create a solid frame, it is absolutely essential that the proximal round hole is secured first with the blue drill guide. 12

15 Note on correct securing of the holes The drill guides for the distal femur plate 4.5 are available in two versions. 1. The drill guide for the round hole LOQTEQ 4.5 is marked blue and is used in distal round holes of the femur plate and in the outermost proximal plate hole. 2. The drill guide for the gliding hole LOQTEQ 4.5 is marked red and is used in the gliding-locking holes in the plate shaft. N NOTE: The blue and red color coding of the drill guides have nothing to do with the color of the screws. For locking screw fixation, please use red headed LOQTEQ locking screws or LOQTEQ periprosthetic screws only! 13

16 Temporary fixation with K-wires INSTRUMENTS ART.-NO. Reduction sleeve for K-wire ø2.0, long IU K-wire with trocar point, ø2.0, L 310 NK For the temporary fixation of the plate with 2.0 mm K-wires, one additional reduction sleeve is inserted in each of the distal stabilization bolts and in the proximal drill guide (blue). After drilling the K-wires, check their position and the plate position using fluoroscopy, and check the length and rotation of the reduced limb. A standard screw can be inserted into the oblong hole to pull the plate up to the bone, if necessary. N NOTE: If a standard screw is used to pull the plate up to the bone, this must occur before the locking screws are placed. 14

17 Insertion of screws in the head of the plate INSTRUMENTS ART.-NO. Drill guide for round hole LOQTEQ 4.5, I-ø 4.2, blue, long IU Twist drill ø3.8, L 310, quick coupling IU Depth gauge for targeting device LOQTEQ DF 4.5 IU In the distal lateral femur plate, only LOQTEQ locking screws (red) are used in the shaft and for the angular stable round holes in the distal plate portion. To secure the round holes in the distal area, screw in the drill guide (blue) through the handle in the desired plate hole. Drill to the desired depth using a drill bit ø3.8 (marked in bluered), if necessary under fluoroscopic monitoring. The screw length can be read directly using the scale at the drill or with the aid of a depth gauge against the drill guide. After measuring the screw length, remove the drill guide. 15

18 INSTRUMENTS ART.-N0. Screwdriver Duo long, SW 3.5, quick coupling IU Torque limiter 3.5 Nm, quick coupling IU Handle for quick coupling, large, cannulated IU Marking plug for handle of targeting frame LOQTEQ DF 4.5 IU Select a LOQTEQ locking screw (red) of the proper length and loosely insert it directly through the handle using the self-retaining screwdriver T25. Insert to the yellow marking using handle or automated mode. 16

19 Then tighten the screw using the torque limiter. Optimal fixation is reached once an audible click is heard. N NOTE: It is essential that all screw heads are secured into the plate and not standing proud. With very hard bone it can be necessary to screw without torque limiter. 17

20 Finally, the secured plate hole is marked by a marking plug (yellow). All other screw holes at the head are secured in the same manner. N NOTE: It is recommended to use a torque limiter as soon as the screw head reaches the thread in the plate hole. The yellow mark at the screwdriver shaft serves as orientation (stop mark). N NOTE: It is essential that all screw heads are secured into the plate and not standing proud. With very hard bone it can be necessary to screw without torque limiter. N CAUTION: Do not use the torque limiter in automated mode; instead, only use with the enclosed handle. N NOTE: The screw at the position of the stabilization bolt can only be secured after removal of the targeting device. 18

21 Insertion of screws in the shaft of the plate INSTRUMENTS ART.-NO. Tissue protection sleeve LOQTEQ DF 4.5, long IU Trocar, LOQTEQ DF 4.5 IU Drill guide for gliding hole LOQTEQ 4.5, I-ø 4.2, red, long IU Twist drill ø3.8, L 310, coil 50, quick coupling IU Depth gauge for targeting device LOQTEQ DF 4.5 IU Once all required screws have been placed in the distal area, the shaft area can be secured. For this purpose, insert the tissue protection sleeve with screwed-in trocar into the targeting frame and guide to the plate via a stab incision. Lock the tissue protection sleeve into the targeting frame. Replace the trocar by the drill guide for gliding hole (red) and screw into the tissue protection sleeve. Pilot drill to the desired depth using a drill bit ø3.8 (marked in blue-red), if necessary under fluoroscopic monitoring. The screw length can be read directly using the scale at the drill or against the drill guide with the aid of a depth gauge. After measuring the screw length, remove the drill guide. 19

22 INSTRUMENTS ART.-NO. Screwdriver Duo long, T25, quick coupling IU Torque limiter 3.5 Nm, quick couplin IU Handle for quick coupling, large, cannulated IU Marking plug for targeting frame LOQTEQ DF 4.5 IU Select a LOQTEQ locking screw (red) of the proper length and loosely insert it to the black mark directly through the tissue protection sleeve using the self-retaining screwdriver T25. Do so either with the handle or in automated mode. Finally, manually tighten the screw using the torque limiter. Optimal fixation is reached once an audible click is heard. p p Mark the secured plate hole with a marking plug (black). Except for the most proximal plate hole, all other screw holes in the shaft area can be secured in the same way. N NOTE: It is recommended to use a torque limiter as soon as the screw head reaches the thread in the plate hole. The black mark at the screwdriver shaft serves as orientation (stop mark). N NOTE: It is essential that all screw heads are secured into the plate and not standing proud. With very hard bone it can be necessary to screw without torque limiter. 20

23 The most proximal plate hole and the hole A are secured last. For this purpose, remove the K-wire and the reduction sleeve, and drill, measure, and insert the screw as described above. Once all required screws have been placed, the final fluoroscopy check and wound closure are performed. Placement of periprosthetic screws If an intramedullary nail or a prosthesis interferes with bicortical screw placement, special screws for periprosthetic fractures can be used. These periprosthetic screws feature a blunt, very short tip. The LOQTEQ periprosthetic screws are similar in design to the LOQTEQ locking screws (red) but feature a gold head (see image). They allow the plate to be fixed to the near cortex. N NOTE: LOQTEQ periprosthetic screws are available in 14 and 18 mm lengths. The femur plate has a shaft thickness of 6 mm. 21

24 Compression of a shaft fracture with the gliding-locking hole technology from aap INSTRUMENTS ART.-N0. Load drill guide LOQTEQ 3.5, compression 1 mm IU Load drill guide LOQTEQ 3.5, compression 2 mm IU Basic Insert for load drill guide LOQTEQ 3.5 IU OPTIONAL Load drill guide LOQTEQ 4.5, adjustable up to 2 mm IU If compression in the shaft area is desired, it can be achieved with standard screws, with LOQTEQ locking screws (red) or, in cases of an intramedullary implant, LOQTEQ periprosthetic screws (view figure). N NOTE: For mechanical compression with locking screws in the shaft area, do not use the radiolucent targeting device. The instruments for guided compression (see figure) are included in the large fragment set (IC ). Screw the holding pin (IU ) into an appropriate shaft hole or, if necessary, above the fracture line. Choose a compression drill guide in accordance with the compression distance (1 mm or 2 mm) and position on the holding pin, away from the fracture gap. 22

25 Alternatively, the adjustable compression drill guide (IU ) can be used. The fracture gap serves as orientation in the setting of the compression distance (max. 2 mm). For this purpose, turn the wheel of the compression drill guide until an appropriate gap forms in the upper part of the instrument, and position the drill guide on the holding pin, away from the fracture gap. N CAUTION: Be aware to select the proper compression distance (1 or 2 mm). If the fracture gap is small and the bone very hard the screw might not lock flush into the plate. Drill to the desired depth using a drill bit ø3.8 (marked blue-red) and determine the depth with the depth gauge. Select a LOQTEQ locking screw (red) of the proper lenght and insert. In the event of a periprosthetic implant (view figure) drill monocortical and select a LOQTEQ periprosthetic screw (14 or 18 mm). N NOTE: It is recommended to use a torque limiter as soon as the screw head reaches the thread in the plate hole. N NOTE: It is essential that all screw heads are secured into the plate and not standing proud. With very hard bone it can be necessary to screw without torque limiter. N CAUTION: Do not use the torque limiter in automated mode; instead, only use with the enclosed handle. 23

26 Explantation INSTRUMENTS ART.-NO. Screwdriver, hexagonal, SW 3.5 IU *Screwdriver, T25, Round Handle IU Place an incision on the old scar. Manually undo all distal screws and sequentially remove them. Place the handle on the plate and affix. Use stab incisions to manually undo and remove all screws in the plate shaft. If necessary, use the targeting frame and tissue protection sleeves to minimize soft tissue trauma. Remove the plate with the aid of the handle, and close the wound. N NOTE: After manually undoing the screws, the removal can be performed in automated mode in the second step. * The screwdrivers in the set (T25) are selfholding. To achive a secure holding and maximum stability during the explantation we suggest to use the appropriate hexagonal screwdriver, which must be ordered seperately. 24

27 Trays LOQTEQ Distal Femur Plate 4.5, complete set IC A B C D Tray A instruments IC Tray B instruments IC Tray C implants IC Screw Rack IC

28 Trays LOQTEQ Distal Femur Plate 4.5, Tray A Instruments IC A ARTICLE QUANTITY ART.-NO. Tray A for instruments LOQTEQ DF 4.5, empty 1 IC Lid for trays, large 1 IC Raspatory, long curved 1 IU Twist drill ø3.2, L 195, coil 50, quick coupling 1 IU Twist drill ø3.2, L 310, coil 50, quick coupling 1 IU Twist drill ø3.8, L 310, coil 50, quick coupling 1 IU Twist drill ø4.5, L 145, coil 50, quick coupling 1 IU Targeting frame LOQTEQ DF 4.5, right 1 IU Handle for targeting frame LOQTEQ DF 4.5, right 1 IU Stabilization bolt for targeting frame LOQTEQ DF IU Fixing nut for stabilization bolt 1 IU Marking plug for targeting frame LOQTEQ DF IU Marking plug for handle of targeting frame LOQTEQ DF IU Targeting frame LOQTEQ DF 4.5, left 1 IU Handle for targeting frame LOQTEQ DF 4.5, left 1 IU K-wire with trocar point, ø2.0, L NK

29 Trays LOQTEQ Distal Femur Plate 4.5, Tray B Instruments IC B ARTICLE QUANTITY ART.-NO. Tray B for instruments LOQTEQ DF 4.5, empty 1 IC Lid for trays, large 1 IC Depth gauge for locking screws, large 1 IS Tissue spreader 1 IU Handle for quick coupling, large, cannulated 1 IU Screwdriver Duo long, T25, quick coupling 1 IU Screwdriver Duo long, SW 3.5, quick coupling 1 IU Torque limiter 3.5 Nm, quick coupling 1 IU Depth gauge for targeting device LOQTEQ DF IU Screw forceps, self-holding 1 IU MC ACP double drill guide ø3.2/4.5 1 IU Reduction sleeve for K-wire ø2.0, long 2 IU Drill guide for round hole LOQTEQ 4.5, I-ø 4.2, blue, long 3 IU Drill guide for gliding hole LOQTEQ 4.5, I-ø 4.2, red, long 3 IU Tissue protection sleeve LOQTEQ DF 4.5, long 4 IU Trocar, LOQTEQ DF IU

30 Trays LOQTEQ Distal Femur Plate 4.5, Tray C Implants IC C ARTICLE QUANTITY ART.-NO. Tray C for implants LOQTEQ DF 4.5, empty 1 IC Lid for trays, large 1 IC LOQTEQ Dist. Lateral Femur Plate 4.5, 7/7 holes, L 207, R 1 PF LOQTEQ Dist. Lateral Femur Plate 4.5, 7/9 holes, L 243, R 1 PF LOQTEQ Dist. Lateral Femur Plate 4.5, 7/11 holes, L 279, R 1 PF LOQTEQ Dist. Lateral Femur Plate 4.5, 7/13 holes, L 314, R 1 PF LOQTEQ Dist. Lateral Femur Plate 4.5, 7/7 holes, L 207, L 1 PF LOQTEQ Dist. Lateral Femur Plate 4.5, 7/9 holes, L 243, L 1 PF LOQTEQ Dist. Lateral Femur Plate 4.5, 7/11 holes, L 279, L 1 PF LOQTEQ Dist. Lateral Femur Plate 4.5, 7/13 holes, L 314, L 1 PF OPTIONAL LOQTEQ Dist. Lateral Femur Plate 4.5, 7/4 holes, L 153, R 0 PF LOQTEQ Dist. Lateral Femur Plate 4.5, 7/15 holes, L 350, R 0 PF S LOQTEQ Dist. Lateral Femur Plate 4.5, 7/17 holes, L 386, R 0 PF S LOQTEQ Dist. Lateral Femur Plate 4.5, 7/4 holes, L 153, L 0 PF LOQTEQ Dist. Lateral Femur Plate 4.5, 7/15 holes, L 350, L 0 PF S LOQTEQ Dist. Lateral Femur Plate 4.5, 7/17 holes, L 386, L 0 PF S 28

31 Trays LOQTEQ Screw Rack for Extension Screw DF 4.5 ARTICLE QUANTITY ART.-NO. Screw rack LOQTEQ DF 4.5 for extension screw set, empty 1 IC LOQTEQ Cortical Screw 4.5, T25, self-tapping, L 75 6 SK LOQTEQ Cortical Screw 4.5, T25, self-tapping, L 80 6 SK LOQTEQ Cortical Screw 4.5, T25, self-tapping, L 85 6 SK LOQTEQ Cortical Screw 4.5, T25, self-tapping, L 90 6 SK LOQTEQ Periprosthetic Screw 4.5, T25, self-tapping, L SK LOQTEQ Periprosthetic Screw 4.5, T25, self-tapping, L SK

32 Trays LOQTEQ Distal Femus Plate 4.5, Screw Rack IC D ARTICLE QUANTITY ART.-NO. Screw rack LOQTEQ Distal Femur Plate 4.5, empty 1 IC Screws for gliding-locking hole ARTICLE QUANTITY ART.-NO. LOQTEQ Cortical Screw 4.5, T25, self-tapping, L 20 6 SK LOQTEQ Cortical Screw 4.5, T25, self-tapping, L 22 6 SK LOQTEQ Cortical Screw 4.5, T25, self-tapping, L 24 6 SK LOQTEQ Cortical Screw 4.5, T25, self-tapping, L 26 6 SK LOQTEQ Cortical Screw 4.5, T25, self-tapping, L 28 6 SK LOQTEQ Cortical Screw 4.5, T25, self-tapping, L 30 6 SK LOQTEQ Cortical Screw 4.5, T25, self-tapping, L 32 6 SK LOQTEQ Cortical Screw 4.5, T25, self-tapping, L 34 6 SK LOQTEQ Cortical Screw 4.5, T25, self-tapping, L 36 6 SK LOQTEQ Cortical Screw 4.5, T25, self-tapping, L 38 6 SK LOQTEQ Cortical Screw 4.5, T25, self-tapping, L 40 6 SK LOQTEQ Cortical Screw 4.5, T25, self-tapping, L 42 6 SK LOQTEQ Cortical Screw 4.5, T25, self-tapping, L 45 6 SK LOQTEQ Cortical Screw 4.5, T25, self-tapping, L 50 6 SK LOQTEQ Cortical Screw 4.5, T25, self-tapping, L 55 6 SK LOQTEQ Cortical Screw 4.5, T25, self-tapping, L 60 6 SK LOQTEQ Cortical Screw 4.5, T25, self-tapping, L 65 6 SK LOQTEQ Cortical Screw 4.5, T25, self-tapping, L 70 6 SK

33 Trays Standard screws ARTICLE QUANTITY ART.-NO. Cortical Screw 4.5, self-tapping, L 20 4 SK Cortical Screw 4.5, self-tapping, L 22 4 SK Cortical Screw 4.5, self-tapping, L 24 4 SK Cortical Screw 4.5, self-tapping, L 26 4 SK Cortical Screw 4.5, self-tapping, L 28 4 SK Cortical Screw 4.5, self-tapping, L 30 4 SK Cortical Screw 4.5, self-tapping, L 32 4 SK Cortical Screw 4.5, self-tapping, L 34 4 SK Cortical Screw 4.5, self-tapping, L 36 4 SK Cortical Screw 4.5, self-tapping, L 38 4 SK Cortical Screw 4.5, self-tapping, L 40 4 SK Cortical Screw 4.5, self-tapping, L 42 4 SK Cortical Screw 4.5, self-tapping, L 45 4 SK Cortical Screw 4.5, self-tapping, L 50 4 SK Cortical Screw 4.5, self-tapping, L 55 4 SK Cortical Screw 4.5, self-tapping, L 60 4 SK Cortical Screw 4.5, self-tapping, L 65 4 SK Cortical Screw 4.5, self-tapping, L 70 4 SK

34 32 Notes

35 Subject to technical modifications, errors and misprints. WM / 0912 Layout, typesetting: design graphic - Wolfram Passlack Illustrations: Karen Hilberg Lorenzweg Berlin Germany Phone Fax customer.service@aap.de

36 Lorenzweg Berlin Germany Phone Fax customer.service@aap.de WM / 0912 (not for the USA)