Surgical Technique. Suture. Insertion Rod. U-Guide. Grommet Swing Arm. Figure 1. Figure 2. Suture

Transcription

1

2 This brochure is presented to demonstrate the surgical technique utilized by Robert Frederick, M.D. Arthrotek, as the manufacturer of this device, does not practice medicine and does not recommend this or any other surgical technique for use on a specific patient. The surgeon who performs any procedure is responsible for determining and utilizing the appropriate techniques for such procedure for each individual patient. Arthrotek is not responsible for selection of the appropriate surgical technique to be utilized for an individual patient. The AXL Cannulated Cross Pin was developed in conjunction with Robert Frederick, M.D., Philadelphia, Pennsylvania. 1. Kousa P, Jarvinen TL, Vihavainen M, Kannus P, Jarvinen M: The fixation strength of six hamstring tendon graft fixation devices in anterior cruciate ligament reconstruction. Part II: Tibial Site. American Journal of Sports Medicine Mar Apr;31(2):174 81, Soft-tissue grafts have gained popularity over recent years as many surgeons graft preference for anterior cruciate ligament reconstruction. Interference screws were thought to be the gold standard for fixating any graft (soft-tissue or BTB) in an ACL reconstruction. Interference screws offered a simple technique for surgeons. Recent literature suggests that transverse, or cross pin, fixation may provide a stronger and stiffer construct and be better suited for fixating soft-tissue grafts in the femur. 1 The strength of cross pin fixation is attributed to the ability of these devices to purchase the cortical bone in the femur rather than solely relying on the cancellous bone quality of a given patient. The higher strength of a cross pin fixation device may allow for the promotion of aggressive rehabilitation and enabling patients a quicker return to full sport. 1 Having a technique that is reliable and reproducible, as well as having a strong device, is essential for a successful ACL reconstruction. The AXL Cannulated Cross Pin is: Reproducible and Reliable New U-Guide aids in accurate transverse tunnel placement New graft pusher simplifies graft passage and aids in proper placement of the AXL Cannulated Cross Pin Strong AXL Cannulated Cross Pin can capture the cortical bone of the femur giving it superior strength 1 Biologically Friendly Made of either titanium or LactoSorb L-15 material for different material options without sacrificing biocompatibility Figure 1 Suture Prepare hamstring autograft or soft tissue allograft in appropriate manner. Size graft, mark as necessary and pre-tension as per surgeon preference. Perform initial diagnostic arthroscopy, treat other associated intraarticular pathology, debride torn ACL and perform notchplasty. Make proximal medial tibial longitudinal incision. Create periosteal flaps in location of ACL tibial tunnel. At the completion of the procedure, re-approximate the periosteal flaps with sutures to enclose graft and hardware. Position ACL tibial guide and drill guide pin into desired location. Over-ream tibial guide pin with appropriate sized tibial reamer corresponding to diameter of prepared graft (if using WasherLoc Tibial Fixation, ream distal aspect of tibial tunnel to accept fixation device). Insertion Rod Grommet Swing Arm Suture Figure 2 U-Guide Place Femoral Aimer trans-tibially into the appropriate over-the-top position at posterior aspect of lateral femoral condyle and drill guide pin into position. Remove guide. Drill ACL femoral tunnel to appropriate depth (approximately 40mm) utilizing reamer that corresponds to the graft diameter (remember to place knee into the appropriate degree of flexion prior to drilling the femoral tunnel). Place the appropriate diameter insertion rod into the AXL Cross Pin U-Guide and tighten securely (do not place any swing arms between the base of the rod and the U-Guide). Pass a #2 suture through holes in distal tip of insertion rod (Figure 1). The two ends of the suture are then pulled taut as they pass proximally along the rod shaft to the base of the U-Guide where they are tightened securely around the adjacent grommets (Figure 2).

3 Guide Wire AXL Cannulated Drill Bit Figure 3 Figure 5 Figure 6 Figure 4 The distal tip of the insertion rod (on the properly prepared U-Guide ) is inserted trans-tibially into the femoral tunnel to the appropriate depth. Insert the measuring bullet into the lateral arm of the U-Guide and rotate the guide so that the bullet touches the skin anterior to the lateral epicondyle, as per surgeon preference. Mark the skin and make an incision using a #11 blade through the skin, iliotibial band, and periosteum directly to bone. Adjust orientation of U-Guide so that the measuring bullet is parallel with floor or slightly angled posterorlateral to anteromedial. Lock the targeting bullet into place (with its tip touching the bone of the lateral cortical wall) with the adjacent thumbscrew. Read the calibrated markings on the bullet to determine the AXL Cross Pin implant length (Figure 3). Pass guide-wire through targeting bullet and drill across both femoral condyles, exiting through a small puncture wound in the skin medially (Figure 4). Remove targeting bullet. Drill the AXL cannulated drill over the guide-wire until drill stop contacts lateral surface of U-Guide (indicating tip of drill bit reaching appropriate depth through lateral wall of ACL femoral tunnel) (Figures 5 & 6). Remove AXL Drill. Thread a #2 transverse pin alignment suture through eyelet of the AXL implant passing pin. Hold two ends of suture and slide pin to opposite end. Take free ends of transverse pin alignment suture and now pass them through the eyelet in the proximal tip of the transverse guide-wire (the one that passes lateral to medial through the femoral condyles). Pull the transverse guide wire by its medial tip so it passes across both femoral condyles and out the skin medially (pulling the #2 transverse pin alignment suture with it across both condyles) (Figure 7). Guide Wire Transverse Pin Alignment Suture AXL Implant Passing Pin Figure 7

4 Figure 9 Figure 10 Figure 8 Remove the guide-wire from the sutures (on medial aspect of knee) and clamp both ends of the transverse pin alignment suture together with a Kelly or similar clamping instrument. Remove the U-Guide from the knee pulling the transverse pin alignment suture (via the suture passed through the eyelets in the end of the insertion rod) out of the tibial tunnel (Figure 8). Release the transverse pin alignment suture from the U-Guide and clamp it to the drape above the knee. Note: Make sure the transverse pin alignment suture does not rotate or twist and maintains its orientation i.e. the suture exiting medial condyle stays medial, that which exits the lateral tunnel remains lateral (Figure 9). Place the previously prepared soft tissue graft over the forked end of the graft inserter such that the graft is folded in half with the two free ends passing proximally along shaft of the inserter. The sutures from the ends of tendons are wrapped around the spring loaded channels in their respective handle and the handle is then ratcheted to pull both tendon strands taut to facilitate graft passage. Pass the graft inserter assembly transtibially and up into the femoral tunnel maintaining the proper orientation of the graft (graft strands sitting anterior and posterior within femoral tunnel, handle perpendicular to path of transverse guide-wire). The inserter is passed to top of femoral tunnel until it is fully seated with the loops of the graft positioned above the transverse tunnel (you can confirm appropriate passage with depth markings on graft or shaft pre-measured and marked prior to securing graft to inserter) (Figure 10). Release transverse pin alignment suture from the drape while maintaining proper orientation of its strands. Pass the anterior limb(s) of the graft through the free loop of this suture (Figure 11). (DO NOT let the suture twist!!!) Figure 11

5 Figure 14 Figure 15 Transverse Pin Alignment Suture AXL Implant Passing Pin AXL Implant Passing Pin Figure 16 Figure 12 Figure 13 Pull on both ends of the transverse pin alignment suture as they exit both femoral condyles so the suture passes to the top of the femoral tunnel between the anterior and posterior strands of the soft tissue graft. Pull the graft inserter out both tunnels while maintaining tension on both ends of the transverse pin alignment suture (Figure 12). Pull the transverse pin alignment suture medially to advance the AXL implant passing pin into the lateral femoral condyle, below the loop in the soft tissue graft and then across the medial femoral condyle (Figure 13). Advance AXL obturator and sheath over the AXL implant passing pin through skin incision, through iliotibial band and down to the lateral cortex of the femur (Figure 14). Remove obturator making certain the sheath stays on the lateral cortex of the femur. Load the pre-determined length AXL Cannulated Cross Pin onto the implant passing pin (Figure 15). Mate the AXL implant driver with the AXL Cannulated Cross Pin. Advance the AXL Cannulated Cross Pin through the sheath until the implant is countersunk 5mm (Figure 16). Place sufficient traction on tendon strands exiting tibial tunnel to tension graft against AXL Cannulated Cross Pin and cycle knee to surgeons preference. Secure the soft tissue graft distally with the desired tibial fixation device. (Figure 17). Figure 17

6 Alternative AXL Cannulated Cross Pin Insertion Technique Package Insert Figure A Load the pre-determined length AXL Cannulated Cross Pin onto the implant passing pin (Figure A). Mate the AXL implant driver with the AXL Cannulated Cross Pin and advance into place to the appropriate depth (countersunk 5mm) (Figures B & C). The depth is determined by reading markings on the drive as it passes through the insertion sheath. BE SURE that the insertion sleeve is on cortical bone to ensure accurate depth measurements. Tension and secure the soft tissue graft distally with the desired tibial fixation device (Figure D). Figure C Figure B Arthrotek, Inc A Wholly Owned Subsidiary of Biomet, Inc. P.O. Box 587 Date: 09/05 56 East Bell Drive Warsaw, Indiana USA Arthrotek Internal Fixation Devices Attention Operating Surgeon DESCRIPTION Arthrotek manufactures a variety of internal fixation devices intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or degenerative disease. Implants used for this application include: screws, washers, anchors, pins, and suture. Specialty implants are available for specialized treatments. Materials: 316 LVM Stainless Steel Titanium Alloy Ultra-High Molecular Weight Polyethylene (UHMWPE) Polyester INDICATIONS The Metal Screw Anchor and the Harpoon Suture Anchor are indicated for use in soft tissue reattachment procedures in the shoulder, wrist, elbow, and knee. Specific indications as follows: Shoulder Indications Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair. Wrist/Hand Indications Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction. Ankle/Foot Indications Lateral stabilization, medial stabilization, Achilles tendon repair/ reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction. Elbow Indications Ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction. Knee Indications Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, and patellar ligament/ tendon repair. Bone Mulch Screws are intended for use in fixation of semitendinous and/or gracile tendon grafts in ACL reconstruction, only. Interference Screws and Set Screws are intended for use in fixation of patellar bone-tendon-bone grafts in ACL reconstruction. Screw and Washers are indicated for soft tissue fixation to bone, and bone to bone fixation in orthopedic procedures specifically during Ligament reconstruction. Toggle anchors (ie. toggle buttons and EZLoc ) are indicated for use for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction. Patient selection factors to be considered include: 1) need for soft tissue to bone fixation, 2) ability and willingness of the patient to follow postoperative care instructions until healing is complete, and 3) a good nutritional state of the patient. CONTRAINDICATIONS 1. Infection. 2. Patient conditions including blood supply limitations, and insufficient quantity or quality of bone or soft tissue. 3. Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions. 4. Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation of the device. WARNINGS Arthrotek internal fixation devices provide the surgeon with a means to aid in the management of soft tissue to bone reattachment procedures. While these devices are generally successful in attaining these goals, they cannot be expected to replace normal healthy bone or withstand the stress placed upon the device by full or partial weight bearing or load bearing, particularly in the presence of nonunion, delayed union, or incomplete healing. Therefore, it is important that immobilization (use of external support, walking aids, braces, etc.) of the treatment site be maintained until healing has occurred. Surgical implants are subject to repeated stresses in use, which can result in fracture or damage to the implant. Factors such as the patient s weight, activity level, and adherence to weight bearing or load bearing instructions have an effect on the service life of the implant. The surgeon must be thoroughly knowledgeable not only in the medical and surgical aspects of the implant, but also must be aware of the mechanical and metallurgical aspects of the surgical implants. 1. Correct selection of the implant is extremely important. The potential for success in soft tissue to bone fixation is increased by the selection of the proper type of implant. While proper selection can help minimize risks, neither the device nor grafts, when used are designed to withstand the unsupported stress of full weight bearing, load bearing or excessive activity. 2. The implants can loosen or be damaged and the graft can fail when subjected to increased loading associated with nonunion or delayed union. If healing is delayed, or does not occur, the implant or the procedure may fail. Loads produced by weight bearing, and activity levels may dictate the longevity of the implant. 3. Inadequate fixation at the time of surgery can increase the risk of loosening and migration of the device or tissue supported by the device. Sufficient bone quantity and quality are important to adequate fixation and success of the procedure. Bone quality must be assessed at the time of surgery. Adequate fixation in diseased bone may be more difficult. Patients with poor quality bone, such as osteoporotic bone, are at greater risk of device loosening and procedure failure. 4. Implant materials are subject to corrosion. Implanting metals and alloys subjects them to constant changing environments of salts, acids, and alkalis that can cause corrosion. Putting dissimilar metals and alloys in contact with each other can accelerate the corrosion process that may enhance fracture of implants. Every effort should be made to use compatible metals and alloys when marrying them to a common goal, i.e., screws and plates. 5. Correct handling of implants is extremely important. Do not modify implants. Do not notch or bend implants. Notches or scratches put in the implant during the course of surgery may contribute to breakage. Intraoperative fracture of screws can occur if excessive force (torque) is applied while seating bone screws. 6. Do not use excessive force when inserting suture anchors. Excessive force (long hard hammer blows) may cause fracture or bending of the device. When encountering hard cortical bone, predrill with a 3/32 or 1/8 inch drill prior to inserting suture anchors. 7. Adequately instruct the patient. Postoperative care is important. The patient s ability and willingness to follow instructions is one of the most important aspects of successful fracture management. Patients effected with senility, mental illness, alcoholism, and drug abuse may be at a higher risk of device or procedure failure. These patients may ignore instructions and activity restrictions. The patient is to be instructed in the use of external supports, walking aids, and braces that are intended to immobilize the fracture site and limit weight bearing or load bearing. The patient is to be made fully aware and warned that the device does not replace normal healthy bone, and that the device can break, bend or be damaged as a result of stress, activity, load bearing, or weight bearing. The patient is to be made aware and warned of general surgical risks, possible adverse effects, and to follow the instructions of the treating physician. The patient is to be advised of the need for regular postoperative follow-up examination as long as the device remains implanted. PRECAUTIONS Do not reuse implants. While an implant may appear undamaged, previous stress may have created imperfections that would reduce the service life of the implant. Do not treat with implants that have been even momentarily placed in a different patient. Instruments are available to aid in the accurate implantation of internal fixation devices. Intraoperative fracture or breaking of instruments has been reported. Surgical instruments are subject to wear with normal usage. Instruments, which have experienced extensive use or excessive force, are susceptible to fracture. Surgical instruments should only be used for their intended purpose. Arthrotek recommends that all instruments be regularly inspected for wear and disfigurement. If device contains MaxBraid suture, refer to manufacturer package insert for further information. POSSIBLE ADVERSE EFFECTS 1. Nonunion or delayed union, which may lead to breakage of the implant. 2. Bending or fracture of the implant. 3. Loosening or migration of the implant. 4. Metal sensitivity, or allergic reaction to a foreign body. 5. Pain, discomfort, or abnormal sensation due to the presence of the device. 6. Nerve damage due to surgical trauma. 7. Necrosis of bone or tissue. 8. Inadequate healing. 9. Intraoperative or postoperative bone fracture and/or postoperative pain. STERILITY Arthrotek internal fixation implants are typically supplied sterile and are sterilized by exposure to a minimum dose of 25kGy of gamma radiation or by Ethylene Oxide Gas (ETO) if device contains MaxBraid PE suture. If supplied sterile, do not resterilize the implant. If not supplied sterile, metallic internal fixation devices must be sterilized prior to surgical use. Do not sterilize UHMWPE implants using steam autoclaving methods. Do not use implants after expiration date. Pre-VacuumSteam (HI-VAC) -- wrapped or unwrapped Temperature F ( C) Exposure Time 5 Minutes Drying Time 8 Minutes Since Arthrotek is not familiar with individual hospital handling methods, cleaning methods and bioburden, Arthrotek cannot assume responsibility for sterility even though the guideline is followed. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Authorized Representative: Biomet U.K., Ltd. Waterton Industrial Estates, Bridgend, South Wales CF31 3XA, U. K The information contained in this package insert was current on the date this brochure was printed. However, the package insert may have been revised after that date. To obtain a current package insert, please contact Arthrotek at the contact information provided herein. Figure D

7 Ordering Information L15 AXL Cannulated Cross Pin mm mm mm Titanium AXL Cannulated Cross Pin mm mm mm AXL Cannulated Cross Pin U-Guide AXL Cannulated Cross Pin Measuring Bullet AXL Cannulated Cross Pin Superior Bullet AXL Cannulated Cross Pin Insertion Rod mm mm mm mm mm mm AXL Cannulated Cross Pin Driver AXL Cannulated Cross Pin Driver without Sleeve Graft Pusher Graft Pusher Shaft mm mm Cross Pin Bullet Obturator AXL Cross Pin Cannulated Obturator AXL Cross Pin Sheath AXL Reamer Reusable AXL Cannulated Cross Pin Instrument Case Instrument Case Lid Disposable Implant Guide Pin Disposable Reamer (for implant tunnel) AXL Cannulated Cross Pin Disposable Kit AXL and WasherLoc are trademarks of Arthrotek, Inc. LactoSorb is a trademark of Biomet Manufacturing Corp. P.O. Box 587, Warsaw, IN ext Arthrotek, Inc. All Rights Reserved web site: arthrotek@arthrotek.com Form No. Y-BMT-957/031506/K I N V E N T I N G T H E F U T U R E O F A R T H R O S C O P Y