CHARLOTTE. Compression Staple

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CHARLOTTE Compression Staple

CHARLOTTE compression staple surgical technique SURGICAL ADVISORS ROBERT ANDERSON, MD BRUCE COHEN, MD W. HODGES DAVIS, MD Proper surgical procedures and techniques are the responsibility of the medical professional. The following guidelines are furnished for information purposes only. Each surgeon must evaluate the appropriateness of the procedures based on his or her personal medical training and experience. Prior to use of the system, the surgeon should refer to the product package insert for complete warnings, precautions, indications, contraindications and adverse effects. Package inserts are also available by contacting Wright Medical Technology, Inc.

CHARLOTTE COMPRESSION STAPLE CHARLOTTE COMPRESSION STAPLE as described by Robert Anderson, MD; Bruce Cohen, MD; and W. Hodges Davis, MD INTRODUCTION The CHARLOTTE Compression Staple System is a highly versatile implant for osteotomies and arthrodeses of the foot. It is particularly useful in calcaneal-cuboid joint fusions, talonavicular fusions, calcaneal osteotomies, arthrodeses of the midfoot joints, midfoot osteotomies, and corrective osteotomies of the forefoot. The CHARLOTTE Compression Staple is a unique low-profile device that delivers a great deal of compression across a joint. SURGICAL GOALS To provide maximum compression across the fusion site of two bones from an adjacent position. To ensure maximum stiffness of the fusion construct while minimizing device profile. To utilize a device highly resistant to pullout. SYSTEM BASICS All CHARLOTTE Compression Staple implant components are manufactured from surgical grade stainless steel for maximum strength and stiffness. Staples are measured in leg length (distance from the underside of the staple to the tips of the legs) and interaxis distance (inside distance between legs). Staples are available with leg lengths of 11, 13, 15, 17, 20 and 25mm. Staples are available with interaxis distances of 13, 15, 20, and 25mm. one

CHARLOTTE COMPRESSION STAPLE SURGICAL TECHNIQUE - CALCANEAL CUBOID FUSION EXPOSURE/PREPARATION Expose the calcaneal cuboid joint through a lateral (Ollier) incision. Distract the joint with a lamina spreader, and sharply debride the articular cartilage to expose bleeding subchondral bone. A powered drill can also be used to further penetrate the subchondral bone and ensure that bleeding bony surfaces are in apposition prior hardware placement. FIGURE 1 STAPLE SIZING Interaxis distance is chosen so that the staple will span the fusion site and leave an adequate bony bridge between the staple legs. The CHARLOTTE Drill Guide (P/N 43112030) can be used as a visual reference. The staples are intended for unicortical fixation. The leg length is chosen to be as long as possible without penetrating the opposite cortex. If in between sizes, use the shorter leg length. FIGURE 2 DRILL GUIDE ADJUSTMENT The CHARLOTTE Drill Guide must be adjusted to match the staple s interaxis distance. Retrieve the appropriate staple from the surgical tray using the CHARLOTTE Combination Holder/Spreader (P/N 43112001). FIGURE 1 Loosen the sliding mechanism on the CHARLOTTE Drill Guide by turning the thumbscrew on the handle. Insert the legs of the chosen staple into the grooves on the top of the instrument and re-tighten the thumbscrew to lock. FIGURE 2 Set the staple aside for later use. Alternatively, set the gauge to the appropriate size using the scale printed on the drill guide and verify with the staple. two

CHARLOTTE COMPRESSION STAPLE SURFACE PREPARATION Assess the surface upon which the compression staple will sit. If the surface is uneven or irregularly contoured, the staple may not sit flush after insertion. If necessary, bone may be removed with rongeurs or a powered burr prior to staple placement. Leave as much cortical bone intact as possible, particularly in the regions that will support the staple legs. FIGURE 3 HOLE PREPARATION Place the tips of the Drill Guide against the bony surface in the desired location of the staple legs (preferably with equal amount of bone on each side of the area to be compressed). Attach the 3.0mm CHARLOTTE Drill (P/N 43112032) to a powered driver using a medium Jacobs chuck, and drill through both tubes of the CHARLOTTE Drill Guide. FIGURE 3 Since the staples are designed for unicortical placement, it is only necessary to drill through the 1st cortex and underlying cancellous bone. STAPLE INSERTION Manually insert the staple into the drilled holes. A rat-tooth hemostat may be helpful for holding the staple during insertion. Use manual pressure and/or impaction to ensure that the staple sits flush with the underlying bone. FIGURE 4 If necessary, use the CHARLOTTE Staple Impactor (P/N 42112004) and a mallet to finish insertion. FIGURE 4 STAPLE COMPRESSION To adjust compression, use the CHARLOTTE Combination Holder/Spreader to squeeze the sides of the expansion mechanism outward, drawing the staple legs together. FIGURE 5 Use firm pressure to ensure maximum compression; however, use caution in soft bone as the legs may tend to plow through the drilled holes if excessive force is used. Surgical closure is performed in the normal fashion. FIGURE 5 three

four

ORDERING information CHARLOTTE COMPRESSION STAPLE PART NUMBER DESCRIPTION 43110001 COMPRESSION STAPLE, 13I X 11L 43110002 COMPRESSION STAPLE, 13I X 13L 43110012 COMPRESSION STAPLE, 13I X 17L 43110003 COMPRESSION STAPLE, 15I X 11L 43110004 COMPRESSION STAPLE, 15I X 13L 43110005 COMPRESSION STAPLE, 15I X 15L 43110006 COMPRESSION STAPLE, 20I X 15L 43110007 COMPRESSION STAPLE, 20I X 20L 43110008 COMPRESSION STAPLE, 20I X 25L 43110009 COMPRESSION STAPLE, 25I X 20L INSTRUMENTS 43112001 COMPRESSION STAPLE, HOLDER/SPREADER 42112004 STAPLE IMPACTOR 43112030 COMPRESSION STAPLE, DRILL GUIDE 43112032 COMPRESSION STAPLE, 3.0MM DRILL 41112016 MTP FUSION, SCREW DEPTH GAUGE SURGICAL TRAY 43110011 COMPRESSION STAPLE, SURGICAL TRAY Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 901.867.9971 phone 800.238.7188 toll-free www.wmt.com Wright Cremascoli Ortho SA Zone Industrielle la Farlecle Rue Pasteur BP 222 83089 Toulon Cedex 09 France 011.33.49.408.7788 phone Trademarks and Registered marks of Wright Medical Technology, Inc. Patents pending. 2005 Wright Medical Technology. Inc. All Rights Reserved SO 030-105 Rev 7-05