1 ™ SwitchCut All-Inside ACL Reconstruction ™ ™ with ZipLoop utilizing ToggleLoc with autograft hamstring Surgical Technique
2 Table of Contents ... 1 Graft Harvest Graft Preparation ... 1 Portal Preparation ... 2 Femoral Tunnel Drilling ... 3 Tibial Tunnel Drilling 8 ... Graft Passage and Tensioning ... 19 Ordering Information ... 12 Indications and Contraindications ... 13
3 1 | Surgical Technique SwitchCut All-Inside ACL Reconstruction Tibia Femur Figure 1a Locking Sutures Figure 2a Figure 1b Tibia Femur Locking Sutures Figure 2b Figure 1c Graft Harvest Graft Preparation Make an oblique incision anteriorly over the The graft is loaded through the tibial ToggleLoc hamstring, this will allow for better visualization and Fixation Inline Device with ZipLoop Technology and folded in half. The two free ends of the hamstring graft hamstring mobilization. To help achieve a minimum ™ of 270 mm of graft length, use the periosteal stripping are whip stitched together using the ExpressBraid suture (Figure 1). Cut the suture at the crimping of the technique. ExpressBraid needle, leaving two free strands that will be used as the locking stitch. The hamstring graft is then loaded through the preferred femoral ToggleLoc with ZipLoop (standard or inline) and folded over, creating a quadrupled hamstring graft (Figure 2).
4 2 | Surgical Technique SwitchCut All-Inside ACL Reconstruction Figure 3a Figure 3b Figure 4 Figure 3c Portal Preparation (cont.) Graft Preparation The lateral portal is placed just off the patella at the The whip stitched free ends of the hamstring grafts level of the distal patella pole. The medial portal is are saved and docked into the core of the graft by established by inserting a spinal needle just above passing one strand of the ExpressBraid suture to the center of the graft and then attaching to the graft the anterior horn of the medial meniscus. After portals are placed, remove the fat pad and the ACL tensioner post. Proceed by doing a single pass-triple circlage-single pass compression stitch utilizing two remnant. Widen the notch if warranted by patient ™1 ™ femoral #2 sutures about 15 mm from each end of MaxBraid anatomy to better visualize the I.D.E.A.L. the quadrupled hamstring graft (Figure 3). tunnel position and easier access for the SwitchCut Femoral guide. Size the quadrupled hamstring graft using the Zimmer Biomet graft sizing block. Use the Zimmer Biomet graft prep table to apply 10–15 lbs of tension to the graft construct. Leave under dampened gauze until ready to implant into patient. Note: Mark the graft 15 mm from each end of the graft and at the mid portion of the graft (Figure 4).
5 3 | Surgical Technique SwitchCut All-Inside ACL Reconstruction Figure 5a Figure 6 Figure 5 Create a Femoral Tunnel with the SwitchCut Reamer Ream in a clockwise forward direction through the Once the SwitchCut tip has penetrated the entrance lateral cortex into the joint space (Figures 5 & 5a). of the joint, as shown in Figure 5a, then rotate the bullet 90 ̊. Remove the SwitchCut guide from the joint space, leaving the bullet in place (Figure 6).
6 4 | Surgical Technique SwitchCut All-Inside ACL Reconstruction Figure 8 Figure 7 Figure 8a Create a Femoral Tunnel (cont.) with the SwitchCut Reamer Take the SwitchCut 4.5 mm bullet until it hits the Advance the tip of the SwitchCut reamer to the bold femoral lateral cortex bone bring down to cortex, black line. This will zero out the SwitchCut reamer measure, and ream back leaving 5–7 mm of cortical (Figure 8). Once the black etched line is aligned with bone (Figure 7). the intra-articular entrance, slide the O-ring to the back of the bullet (Figure 8a).
7 5 | Surgical Technique SwitchCut All-Inside ACL Reconstruction Figure 9 Figure 9a Ream the Femoral Socket Ream in a counterclockwise (reverse) direction to drill If desired, retro-ream until the SwitchCut reamer the femoral socket. The arm on the SwitchCut reamer bottoms out on the bullet tip, which will leave a will automatically deploy as soon as it contacts bone 7 mm bone bridge. Do NOT continue to ream once (Figure 9). Ensure the drill is running at a maximum the reamer makes contact with the bullet, as this counterclockwise speed and maintain a constant may cause the tip of the reamer to break. Then ® and slow retro reaming motion. While retro reaming, Chuck from the SwitchCut disconnect the Jacobs count the etch marks on the SwitchCut reamer to reamer. determine the femoral socket depth, knowing that each etch line represents 5 mm (Figure 9a).
8 6 | Surgical Technique SwitchCut All-Inside ACL Reconstruction Figure 10 Figure 10a Shuttle the Nitinol Loop Passer Remove the blue handled k-wire by twisting counterclockwise (reverse) (Figure 10) and pass the Nitinol loop passer, kite side first, down the SwitchCut reamer as shown (Figure 10a).
9 7 | Surgical Technique SwitchCut All-Inside ACL Reconstruction Figure 11 Figure 11a Shuttle the Nitinol Loop Passer (cont.) Pass the Nitinol loop passer until it is seen in the joint space. Use a suture retriever to pull the loop passer Note: Once the loop passer is out of the joint out of the joint space (Figures 11 and 11a). space, gently remove the SwitchCut reamer by hand with a clockwise twisting motion. When the SwitchCut reamer has been withdrawn, bring both ends of the Nitinol wire together and clamp them using a hemostat.
10 8 | Surgical Technique SwitchCut All-Inside ACL Reconstruction F i g u r e 12 F i g u r e 13 Tibial Tunnel Drilling Set the blue grommet at the back of the bullet to Before inserting the SwitchCut Tibial guide into the monitor your tibial socket depth. The SwitchCut patient make sure the tibial guide is set between drill is run in reverse to the desired socket depth, 50 and 60 degree based on patient’s anatomy to aiming for a 5–10 mm boney bridge. Remove the accommodate a minimum tibial tunnel length of blue handled k-wire from the SwitchCut drill and 30 mm. The SwitchCut Tibial guide is then placed pass the nitinol kite through the reamer into the joint in the heart of the tibial footprint in the medial space. Use a retrieving instrument to pull the kite out half of the notch at the level of the anterior horn the medial portal. of the lateral meniscus. The SwitchCut Guide bullet is then locked into place on the tibial cortex through the hamstring harvest incision site. Read the laser etch marking on tibial bullet to determine the overall tibial tunnel length (Figure 12). Utilize the SwitchCut Drill that matches the diameter of the quadrupled hamstring graft. Drill in clockwise direction until the SwitchCut drill exits the tibial plateau and is capture by the elbow of the tibial guide (Figure 12 and 13). Rotate the bullet 90 degrees and remove the Tibial guide from joint space.
11 9 | Surgical Technique SwitchCut All-Inside ACL Reconstruction Figure 15 Figure 14 Graft Passage and Tensioning Load the ToggleLoc w/ ZipLoop standard passing suture into the SwitchCut nitinol kite that is passing through the femoral tunnel and outside the medial portal standard (Figure 14). Pull proximally on the kite to pass the ToggleLoc passing suture through the portal and out the femoral tunnel to the lateral thigh. Use the ToggleLoc passing suture to advance the ToggleLoc femoral button through the medial portal and onto the lateral cortex. Placing a mark on the ZipLoop strands equaling the interosseous tunnel length will help indicate that the button is beyond the lateral femoral cortex and ready to deploy (Figure 15).
12 10 | Surgical Technique SwitchCut All-Inside ACL Reconstruction Figure 16 Figure 17 (cont.) Graft Passage and Tensioning Advance the graft into the femoral socket using the Using the tibial SwitchCut kite, pass the white pull zipping strands of the standard or inline ToggleLoc strands and the blue white inline zipping strands from device w/ ZipLoop Technology while maintaining the tibial ToggleLoc Inline device into the medial portal slight back tension on the graft until 10 to 15 mm of and down through the tibial tunnel. Then pull on all 6 graft fills the femoral socket (Figure 16). strands delivering the ToggleLoc button through the medial portal and down through the tibial cortical hole.
13 11 | SwitchCut All-Inside ACL Reconstruction Surgical Technique Figure 19 Figure 18 (cont.) Graft Passage and Tensioning Hold the ToggleLoc button perpendicular to the tibial hole with needle drivers and slowly advance the button down to the tibial cortex by pulling on the ToggleLoc w/ ZipLoop inline zipping strands (Figure 18). Continue this tensioning until the ToggleLoc button is flush to the tibial cortex (Figure 19). Adjust final tension on the femoral and tibial side using the zipping strands to ensure that the middle purple mark on the graft is approximately centered in the notch and the desired graft tension is achieved. Tie the core strands over the tibial button.
14 12 | Surgical Technique SwitchCut All-Inside ACL Reconstruction Ordering Information Size Part Number Product Description 4.5 x 6.0 mm SwitchCut Reamer Kit 11 0 0 2 7 6 74 4.5 x 6.5 mm 11 0 0 2 7 6 7 5 4.5 x 7.0 mm 110027676 11 0 0 2 7 6 7 7 4.5 x 7.5 mm 11 0 0 2 7 6 7 8 4.5 x 8.0 mm 11 0 0 2 7 6 7 9 4.5 x 8.5 mm 4.5 x 9.0 mm 11 0 0 2 7 6 8 0 4.5 x 9.5 mm 11 0 0 2 7 6 8 1 11 0 0 2 7 6 8 2 4.5 x 10 mm 6.0 x 11.0 mm 11 0 0 2 7 6 8 4 11 0 0 2 7 6 8 6 6.0 x 12.0 mm SwitchCut Universal Guide Body – 11 0 0 2 6 8 9 9 – 110026900 SwitchCut Femoral guide Arm Right – SwitchCut Femoral guide Arm Left 11 0 0 2 6 9 0 1 22 mm 11 0 0 2 6 9 0 3 SwitchCut Tibial Guide to Point 11 0 0 2 6 8 9 8 SwitchCut Guide Bullet 4.5 mm ID 6.0 mm ID 110026902 – 904755 ToggleLoc Fixation Device with ZipLoop Technology – ToggleLoc with ZipLoop Inline 110005087 ExpressBraid Single White 110003540 – – 110003539 ExpressBraid Single Blue/White – B X /12 9 0 0 3 3 6 MaxBraid CO-Braid Suture #2-0, AT-2 Half Circle Tapered NDLS
15 13 | SwitchCut All-Inside ACL Reconstruction Surgical Technique INDICATIONS FOR USE CONTRAINDICATIONS The ToggleLoc System devices, except the ToggleLoc Infection. 1. XL device, are intended for soft tissue to bone fixation 2. Patient conditions including blood supply for the following indications: limitations, and insufficient quantity or quality of Shoulder bone or soft tissue. Bankart lesion repair Patients with mental or neurologic conditions who 3. SLAP lesion repairs are unwilling or incapable of following postoperative Acromio-clavicular repair care instructions. Capsular shift/capsulolabral reconstruction Deltoid repair 4. Foreign body sensitivity. Where material sensitivity Rotator cuff tear repair is suspected, testing is to be completed prior to Biceps Tenodesis implantation of the device. Foot and Ankle Medial/lateral repair and reconstruction Mid- and forefoot repair Hallux valgus reconstruction Metatarsal ligament/tendon repair or reconstruction Achilles tendon repair Ankle Syndesmosis fixation (Syndesmosis disruptions) and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures (only for ToggleLoc with Tophat/ZipTight Fixation Devices) Elbow Ulnar or radial collateral ligament reconstruction Lateral epicondylitis repair Biceps tendon reattachment Knee ACL/PCL repair / reconstruction ACL/PCL patellar bone-tendon-bone grafts Double-Tunnel ACL reconstruction Extracapsular repair: MCL, LCL, and posterior oblique ligament Illiotibial band tenodesis Patellar tendon repair VMO advancement Joint capsule closure Hand and Wrist Collateral ligament repair Scapholunate ligament reconstruction Tendon transfers in phalanx Volar plate reconstruction The ToggleLoc XL device is used for fixation of tendons and ligaments in cases of unanticipated intraoperative complications such as cortical breaching during orthopedic reconstruction procedures, such as Anterior Cruciate (ACL) or Posterior Cruciate (PCL) Reconstruction.
16 References I.D.E.A.L. ACL Philosophy: Isometric, Direct fibers, Eccentric, 1. Anatomic, Low tension Howell, S. M., McAllister, D., Pearle, A. D. 5 Points on Rationale for Strategic Graft Placement in Anterior Cruciate Ligament Reconstruction: I.D.E.A.L. Femoral Tunnel Position. The American Journal of Orthopedics. June; 2015 (1): 253–258. Jacobs® is a trademark of Apex Brands, Inc. All content herein is protected by copyright, trademarks and other intellectual property rights, as applicable, owned by or licensed to Zimmer Biomet or its affiliates unless otherwise indicated, and must not be redistributed, duplicated or disclosed, in whole or in part, without the express written consent of Zimmer Biomet. This material is intended for health care professionals. Distribution to any other recipient is prohibited. For product information, including indications, contraindications, warnings, precautions, potential adverse effects and patient counselling information, see the package insert and www.zimmerbiomet.com. Check for country product clearances and reference product specific instructions for use. Zimmer Biomet does not practice medicine. This technique was developed in conjunction with a health care professional. This document is intended for surgeons and is not intended for laypersons. Each surgeon should exercise his or her own independent judgment in the diagnosis and treatment of an individual patient, and this information does not purport to replace the comprehensive training surgeons have received. As with all surgical procedures, the technique used in each case will depend on the surgeon’s medical judgment as the best treatment for each patient. Results will vary based on health, weight, activity and other variables. Not all patients are candidates for this product and/or procedure. Caution: Federal (USA) law restricts this device to sale by or on the order of a surgeon. Rx only. © 2018 Zimmer Biomet Authorised Representative Biomet UK Limited Waterton Industrial Estate Bridgend CF31 3X A United Kingdom Legal Manufacturer Biomet Sports Medicine 56 East Bell Drive 0086 P.O. Box 587 Warsaw, Indiana 46581 USA CE mark on a surgical technique is not valid unless there is a CE zimmerbiomet.com mark on the package label. 1427.1-GLBL-en-REV0618
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