ANTERIOR REFERENCE NEXGEN COMPLETE KNEE SOLUTION. Multi-Reference 4-in-1 Femoral Instrumentation Anterior Reference Surgical Technique

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ANTERIOR REFERENCE NEXGEN COMPLETE KNEE SOLUTION Multi-Reference 4-in-1 Femoral Instrumentation Anterior Reference Surgical Technique For NexGen Cruciate Retaining & Legacy Posterior Stabilized Knees

INTRODUCTION Successful total knee arthroplasty is directly dependent on re-establishment of normal lower extremity alignment, proper implant design and orientation, secure implant fixation, and adequate soft tissue balancing and stability. The NexGen Complete Knee Solution and Multi-Reference 4-in-1 Instruments are designed to help the surgeon accomplish these goals by combining optimal alignment accuracy with a simple, straight-forward technique. The instruments and technique assist the surgeon in restoring the center of the hip, knee, and ankle to lie on a straight line, establishing a neutral mechanical axis. The femoral and tibial components are oriented perpendicular to this axis. Femoral rotation is determined using the posterior condyles or epicondylar axis as a reference. The instruments promote accurate cuts to help ensure secure component fixation. Ample component sizes allow soft tissue balancing with appropriate soft tissue release. This femoral surgical technique was developed in conjunction with: Carl L. Highgenboten, M.D. Charles Rutherford, M.D. Ortho Neuro Consultants, PA 7777 Forest Lane, Suite C-106 Dallas, Texas 75230 John N. Insall, M.D. Giles R. Scuderi, M.D. Insall Scott Kelly Institute Beth Israel Hospital Singer Division 170 East End Avenue at 87th Street New York, NY 10128 Please refer to the package inserts for complete product information, including contraindications, warnings, precautions, and adverse effects. Various components of the NexGen Complete Knee Solution and MICRO-MILL Instrumentation System are covered by one or more of the following: U.S. Patents 4,491,987; 4,524,766; 4,759,350; 4,979,957; 5,059,216: 5,148,920; 5,192,328; 5,255,838; 5,290,313; 5,308,412; 5,344,423; 5,383,875; 5,387,241; 5,395,377; 5,405,396, 5,431,660; 5,443,518; 5,458,645; 5,474,559; 5,484,446; 5,486,180; 5,492,671; 5,540,696; 5,549,686; 5,562,674; 5,571,197; 5,593,411; 5,597,384; 5,613,970; 5,634,927; 5,693,048; 5,743,915; 5,769,855; 5,830,216; 5,853,415; 5,860,981; 5,908,424; 5,916,221 D346,979; D365,396; D367,706; D369,863; D372,309; D373,825; D 376,202. 1

ANTERIOR REFERENCE ABBREVIATED SURGICAL TECHNIQUE 1 Drill 8mm Pilot Hole 2 Insert and Secure Distal Placement Guide 5 Set External Rotation 6 Place Femoral Finishing Guide; Adjust M/L & Pin 2

3 4 Cut Distal Femur Size the Femur 7 Remove Headless Holding Pins 8 Finish the Femur 1. Posterior Condyles 2. Posterior Chamfers 3. Anterior Condyles 4. Anterior Chamfer 5. Base of Trochlear Recess 6. Drill Peg Holes 3

ANTERIOR REFERENCE PREOPERATIVE PLANNING Use the template overlay (available through your Zimmer representative) to determine the angle between the anatomic axis and the mechanical axis. This angle will be reproduced intraoperatively. This surgical technique helps the surgeon ensure that the distal femur will be cut perpendicular to the mechanical axis and, after soft tissue balancing, will be parallel to the resected surface of the proximal tibia. Mechanical Axis 6 6 Mechanical Axis Anatomic Axis Transverse Axis SURGICAL APPROACH The femur, tibia, and patella are prepared independently, and can be cut in any sequence using the principle of measured resection (removing enough bone to allow replacement by the prosthesis). Adjustment cuts may be needed later. 90 4

STEP ONE ESTABLISH FEMORAL ALIGNMENT Drill a hole in the center of the patellar sulcus of the distal femur (Fig. 1), making sure that the hole is parallel to the shaft of the femur in both the anteroposterior and lateral projections. The hole should be approximately one-half to one centimeter anterior to the origin of the posterior cruciate ligament. Medial or lateral displacement of the hole may be needed according to preoperative templating of the A/P radiograph. Use the 8mm IM Drill with step to enlarge the entrance hole on the femur to 12mm in diameter. This will reduce intramedullary pressure during placement of subsequent IM guides. Suction the canal to remove medullary contents. Fig. 2 Fig. 1 Fig. 3 Set the IM Alignment Guide to the proper valgus angle as determined by preoperative radiographs. Check to ensure that the proper Right or Left (Fig. 2) indication is used and engage the lock mechanism (Fig. 3). 5

ANTERIOR REFERENCE The Standard Cut Block must be attached to the IM Alignment Guide for a standard distal femoral resection. The plate should be tightened on the guide prior to use, but the screws should be loosened for sterilization. Remove the Standard Cut Block if a large flexion contracture exists. This will allow for an additional 3mm of distal femoral bone resection (Fig. 4). Fig. 4 Insert the guide into the IM hole on the distal femur. Use the epicondylar axis as a guide in setting the orientation of the IM Alignment Guide. Position the handles of the guide relative to the epicondyles. This does not set rotation of the femoral component, but keeps the distal cut oriented to the final component rotation. Once the proper orientation is achieved, impact the IM guide until it seats on the most prominent condyle. After impacting, check to ensure that the valgus setting has not changed. Ensure that the guide is contacting at least one distal condyle. This will set the proper distal femoral resection. Optional Technique: An Extramedullary Alignment Arch and Alignment Rod can be used to confirm the alignment. If this is anticipated, identify the center of the femoral head before draping. If extramedullary alignment will be the only mode of alignment, use a palpable radiopaque marker in combination with an A/P x-ray to ensure proper location of the femoral head. 6

STEP TWO CUT THE DISTAL FEMUR While the IM Alignment Guide is being inserted by the surgeon, the scrub nurse should attach the Distal Femoral Cutting Guide to the 0 Distal Placement Guide. Drill two holes using the 1/8 in. drill. Place Headless Holding Pins through the two standard pin holes in the anterior surface of the Distal Femoral Cutting Guide marked "0" (Fig. 7). Ensure that the attachment screw is tightened (Fig. 5). Verify that the anterior thumb screw is backed out, away from the bone surface. Fig. 7 Fig. 5 Insert the Distal Placement Guide with the cutting guide into the IM Alignment Guide until the cutting guide rests on the anterior femoral cortex. Distal Femoral Cutting Guide Pin Hole Locations To further stabilize the guide, turn the anterior screw by hand until it contacts the anterior femoral cortex (Fig. 6). Do not overtighten. Optional Technique: The Distal Placement Guide (3 ) can be used to place the Distal Resection Guide in 3 of flexion to protect the anterior cortex from notching. Completely loosen the attachment screw (Fig. 8) in the Distal Placement Guide. Fig. 8 Fig. 6 7

ANTERIOR REFERENCE Use the Slaphammer Extractor to remove the IM Alignment Guide and the Distal Placement Guide (Fig. 9). Additional 2mm adjustments may be made by using the sets of holes marked -4, - 2, +2, and +4. The markings on the cutting guide indicate, in millimeters, the amount of bone resection each will yield relative to the standard distal resection set by the Adjustable IM Alignment Guide and Standard Cut Block. Once the distal femoral resection has been determined, use Holding Pins and/or Silver Spring Pins to further stabilize the guide. Cut the distal femur through the distal cutting slot in the cutting guide using a.050-in. oscillating saw blade (Fig. 10). Check the flatness of the distal femoral cut with a flat surface. If necessary, modify the distal femoral surface so that it is completely flat. This is extremely important for the placement of subsequent guides and for proper fit of the implant. Fig. 9 Fig. 10 8

STEP THREE SIZE FEMUR AND SET EXTERNAL ROTATION Place the A/P Sizing & Rotation Guide flat onto the smoothly cut distal femur. Check to ensure that the proper Right or Left designation is showing on the guide. Make sure that the body of the guide maintains contact with the resected distal femur. Compress the guide until the anterior boom contacts the anterior cortex of the femur, and both feet rest on the cartilage of the posterior condyles. Check to ensure that the boom is not seated on a high spot, or an unusually low spot on the anterior cortex. The position of the boom dictates the exit point of the anterior bone cut and the ultimate position of the femoral component. DETERMINE PROPER EXTERNAL ROTATION The A/P Sizing & Rotation Guide offers three external rotation choices: three, five, and seven degrees. For all varus knees, use the threedegree rotation option (Fig. 12). For knees with a valgus deformity from 10 to 20 degrees, use the five-degree option (Fig. 13). For knees with patellofemoral disease accompanied by bone loss and valgus deformity greater than 20 degrees, use the seven degree option (Fig. 14). Fig. 12 3 varus or neutral Read the femoral size directly from the guide on the anterior boom (Fig. 11). There are eight sizes labeled A through H. If the indicator is between two sizes, the smaller size is typically chosen. This prevents excessive ligament tightness in flexion. Fig. 13 (3 External rotation) 5 10-20 valgus Fig. 11 (5 External rotation) Fig. 14 7 greater than 20 valgus (7 External rotation) 9

ANTERIOR REFERENCE Place two Headless Holding Pins into the appropriate external rotation holes in the body of the A/P Sizing/Rotation Guide. Impact them flush with the guide (Fig. 15). Fig. 15 Remove the A/P Sizing/Rotation Guide, but leave the two headless pins. These pins will serve to establish A/P position and rotational alignment of the Femoral Finishing Guide. Optional Technique: Another method of setting external rotation is to identify the epicondylar axis. To identify the lateral epicondyle, it is necessary to dissect away the patellofemoral ligament. The lateral epicondyle is a discrete point at the center of the lateral collateral ligament attachment. The medial epicondyle can be found by removing the synovium from the medial collateral ligament attachment to the femur. The medial collateral ligament has a broad attachment to the medial epicondyle forming an approximate semicircle (Fig. 16). Choose the center of the diameter. Mark these two points with methylene blue (Fig. 17). Then, draw a line between the two epicondyles on the resected surface of the distal femur (Fig. 18). This line represents the epicondylar axis. Fig. 16 Fig. 17 10

Fig. 18 Fig. 19 Attach the Posterior Reference Guide to the Epicondylar Guide. Place the epicondylar guide on the distal femur, bringing the feet of the rotation guide flush against the posterior condyles of the femur. (Fig 19). Set the rotation of the epicondylar guide parallel to the epicondylar axis. Read the angle of external rotation indicaterd by the Poseterior Reference/Rotation Guide. The epicondylar line is rotated externally 0-8, (4 ±4 ) relative to the posterior condyles 1. Determine the external rotation (3, 5, 7 ) that most closely matches the indicated rotation. 1 Poilvache PL, Insall JN, Scuderi GR, Font-Rodriguez DE. Rotational landmarks and sizing of thedistal femur in TKA. Clinical Orthopaedics and Related Research. 331: 35-36, 1996. 11

ANTERIOR REFERENCE STEP FOUR FINISH THE FEMUR Select the correct size 4-in-1 Femoral Finishing Guide as determined by the measurement from the A/P Sizing/Rotation Guide. Place the finishing guide onto the distal femur, over the headless pins. This determines the A/P position and rotation of the instrument. (The anterior boom on the finishing guide indicates the depth at which the anterior cut will exit the femur and may be used as a check.) The finishing guide may be positioned mediolaterally by sliding it on the headless pins (Fig 21). The width of the finishing guide replicates the width of the distal NexGen CR Femoral Component. The etched lines on the posteromedial and posterolateral surface of the guide reference the width of the NexGen Legacy Posterior Stabilized Knee (LPS) Femoral Component. insert a Silver Spring Pin through the tab on each side of the guide using the Female Hex Driver and Drill Reamer. The pins are designed to automatically disengage the hex driver when fully seated on the guide. Remove the headless pins (Fig. 22). Fig. 22 Use the.050-in./1.27mm oscillating saw blade to cut the femur. Perform the final femoral cuts in the following sequence to allow the guide to maintain optimal stability during bone resection (Fig. 23): Fig. 23 Fig. 21 Pin the 4-in-1 Femoral Finishing Guide to the distal femur with two Short-head Holding Pins through the front. Use the Universal Handle to impact these pins. To further stabilize the guide, 1) posterior condyles 2) posterior chamfer 3) anterior condyles 4) anterior chamfer 5) base of Trochlear Recess 6) drill peg holes 12

Use the center slot on the distal face of the guide to cut the base of the trochlear recess with a reciprocating saw (Fig. 24). Ensure that the saw blade is in line with the femur throughout the cut, and do not angle or fan the blade medially or laterally. Use the two slots on the anterior surface of the guide to make reference marks by scoring the femur with a reciprocating sawblade. This determines the sides of the trochlear recess (Fig. 25) Drill the holes for the two femoral pegs with the Patella/Femoral Drill Bit (Fig. 26) Fig. 24 Fig. 26 Fig. 25 13

ANTERIOR REFERENCE When complete, use the Female Hex Driver to remove the two Silver Spring Pins. Place the hex driver over the spring pin and apply a downward force on the driver sleeve (Fig. 27). Start the Drill/ Reamer in reverse, slowly until the driver hex engages the hex-head of the pin. Continue until the spring pin disengages bone. Use the Slaphammer Extractor to remove the Femoral Finishing Guide, and use a reciprocating saw to complete the sides of the trochlear recess at the two reference marks. Fig. 27 (See other NexGen Instrumentation surgical techniques for methods on resecting and finishing the tibia and the patella.) (See pages 15 and 16 in the Appendix for additional femoral finishing techniques when crossing over to the NexGen LPS Knee.) 14

APPENDIX CROSSOVER TECHNIQUES (When crossing over to a posterior stabilized design) EPI Notch/Chamfer Guide Place the EPI Notch/Chamfer Guide flush with the anterior and distal surfaces of the femur. Use the previously prepared trochlear recess and/or femoral peg holes to locate the guide medio-laterally. Pin the guide to the femur and use the appropriate saw to cut the sides of the notch (Fig. 28). Then use an osteotome to remove the notch. Fig. 28 5-in-1 Femoral Finishing Guide Place the appropriate size 5-in-1 Femoral Finishing Guide onto the femur. It will rest on the resected surface of the anterior and distal femur. The guide will not contact the anterior chamfer. Use the previously prepared trochlear recess and/or femoral peg holes to locate the guide. Secure the guide to the femur with two Shortthreaded Silver Spring Pins using the Female Hex Driver and Drill Reamer. The pins are designed to automatically disengage the pin driver when fully engaged on the guide. Optional Technique: The guide can also be attached with standard 1/8 in. pins through the holes in the anterior and distal portion of the guide. Ensure that the proper size holes are selected for the spring pins or 1/8 in. pins. Fig. 29 Fig. 30 Use a reciprocating saw to cut the sides (Fig. 29) and the base (Fig. 30) of the intercondylar notch. Optional Technique: An oscillating saw with a small width blade may also be used. Or use a normal blade to cut the sides and a chisel or osteotome to cut the base of the recess. Remove the Femoral Finishing Guide. 15

ANTERIOR REFERENCE Notch Chamfer Guide Place the Notch Chamfer Guide on the cut surface of the distal femur with the anterior tab resting in the trochlear recess. Pin the guide to the bone and use a saw to cut the sides of the notch (Fig. 31). Then use an osteotome to remove the notch. Fig. 31 16