CHARLOTTE. MTP Fusion System SURGICAL TECHNIQUE

Transcription

1 CHARLOTTE MTP Fusion System SURGICAL TECHNIQUE

2 CHARLOTTE MTP fusion system surgical technique SURGICAL ADVISORS ROBERT ANDERSON, MD BRUCE COHEN, MD W. HODGES DAVIS, MD CARROLL JONES, 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.

3 CHARLOTTE MTP FUSION SYSTEM with Hex and Cruciform Screw Systems as described by Robert Anderson, MD; Bruce Cohen, MD; W. Hodges Davis, MD; and Carroll Jones, MD INTRODUCTION The CHARLOTTE MTP Fusion System is a set of plates and screws for fusion of the 1st Metatarso-Phalangeal (MTP) joint. Fusion of this joint is most often performed for treatment of end-stage Hallux Rigidus, severe Hallux Valgus, rheumatoid and post-traumatic arthritis, and for revision of nonunions. The combination of plates and screws provides for a very stiff and stable construct, and ensures that the Hallux is fused in proper anatomic alignment. SURGICAL GOALS To encourage rapid fusion of the joint by maximizing the amount of bleeding subchondral bone exposed at the fusion site, without excessive shortening of the toe or removal of structural bone. To correctly orient the MTP joint for natural gait biomechanics and footwear comfort. To enable a high fusion rate and early return to function by creating a very stable fusion construct. This is accomplished through the combination of rigid plating and interfragmentary compression screws. SYSTEM BASICS All implant components are manufactured from surgical grade stainless steel for maximum strength and stiffness. The set includes male and female spherical reamers in 14-24mm radii for preparation of the MTP joint surfaces. Fusion plates come in left and right versions. There is a small length, standard length, and a length suitable for revision cases that require an inter-positional graft. The screws used to secure the plate come in 2.7mm and 3.2mm diameters and 8-24mm lengths. They are designed to be extremely low-profile and are inserted with a self-retaining cruciform driver or hex driver option. The screws used for interfragmentary fixation (cross-joint) are cannulated 3.0mm headless compression screws in 18-34mm lengths.

4 EXPOSURE/PREPARATION A dorsal longitudinal or dorsal medial incision is the recommended surgical approach, as it provides the best exposure for plating of the MTP joint. In patients where healing of the skin flap may be problematic, a medial approach may be considered. Start the incision just proximal to the interphalangeal joint, extend it over the dorsum of the MTP joint medial to the Extensor Hallucis Longus (EHL) tendon, and end on the medial aspect of the metatarsal, 2-3cm proximal to the joint. FIGURE 1 Incise and release the joint capsule collateral ligaments to expose the base of the proximal phalanx and the metatarsal head. FIGURE 1 METATARSAL PREPARATION Displace the phalanx plantarly to expose the metatarsal head. Using a powered drill, place one of the 1.6mm K-Wires (P/N ) proximally through the center of the metatarsal head and into the diaphysis. FIGURE 2 FIGURE 2 Using a Jacobs chuck, attach the Cannulated AO Quick Connect (P/N ) to the power driver and connect the largest female reamer (24mm, P/N ). Place the reamer over the K-Wire and gently ream the metatarsal head until bleeding subchondral bone becomes visible on the joint surface. FIGURE 3 Take care not to run the saw teeth of the reamer against the sesamoids, and check the progress of the reamer frequently to prevent excessive shortening of the metatarsal. If necessary, move progressively down through the reamer sizes until the correct radius has been chosen and the entire surface of articular cartilage has been removed. Take note of the last reamer size used. FIGURE 3

5 PHALANGEAL PREPARATION Reaming of the phalanx is performed in a similar fashion to the metatarsal head. To properly expose the articular surface of the phalanx, elevate it dorsally and distally away from the metatarsal head. A curved McGlamry or Hohman retractor is usually helpful. The 1.6mm K-Wire is again placed in the center of the articular cartilage and directed through the diaphysis. Starting with the smallest male reamer (14mm), gently ream the joint surface. FIGURE 4 Proceed cautiously, taking care not to remove too much bone or damage the metatarsal head. Work up through the reamer sizes until the same radius has been used for both the metatarsal and phalangeal side and the surfaces are fully conforming. FIGURE 4 FIGURE 5 PROVISIONAL PLACEMENT/DORSIFLEXION ASSESSMENT Select the correct plate from the kit for either the left or right foot. Place the plate on the dorsal aspect of the joint with the flared portion over the phalanx, and provisionally fix the plate to both the metatarsal and the phalanx with the 1.6mm K-Wires through the K-Wire holes in the plate. FIGURE 5 While holding the lid from the surgical kit, against the plantar surface of the foot, assess the dorsiflexion of the great toe. All plates have been manufactured with 10 of dorsiflexion, which generally results in 5-10 of Hallux dorsiflexion as measured from the floor. Factors such as patient activity level and shoewear preferences should be considered in determining the correct amount of dorsiflexion. For example, a cavus foot may call for a greater bend. If necessary, remove the plate and make fine adjustments to the dorsiflexion angle with the plate benders (P/N ). Bend in one direction only, and do not exceed 10 of additional bending in either direction. INTERFRAGMENTARY SCREW Load a 1mm K-Wire (P/N ) into the power driver. With the plate provisionally fixed as described above, drive the K-Wire in a distal to proximal direction through the phalanx and metatarsal. Hold the plate tightly to the surfaces of the bone during K-Wire placement to resist positional changes. FIGURE 6

6 FIGURE 7 The starting point for the wire should be on the plantar medial aspect of the phalanx, approximately 1cm distal to the joint line. The wire should be advanced diagonally until the tip is securely placed in the lateral cortical bone of the metatarsal, approximately 1cm proximal to the joint line. FIGURE 6. To measure, use the Cannulated Depth Gauge (P/N ) over the K-Wire, subtract 2mm from the measurement, and select the appropriate cannulated compression screw. Using the 2mm Cannulated Hex Driver (P/N ) in the AO Driver Handle (P/N ), advance the screw over the K-Wire until the head is completely countersunk. The plate should be held tightly to the bones while the screw is advanced. FIGURE 7 The plate may be provisionally fixed to the 1st ray prior to inserting the interfragmentary screws. In this instance, screws are placed in the proximal and distal (oval) holes. These screws may be partially tightened and then completely tightened after the interfragmentary and remaining plate screws have been placed. FIGURE 8 PLATE SCREW PLACEMENT The screw insertion process is the same for all hole locations in the plate. Select the screw diameter based upon the patient s bone quality. The smaller diameter screws (2.7mm) should provide sufficient fixation in most patients, while the larger diameter screws (3.2mm) may be used in osteoporotic patients. Using the 2.7mm screw whenever possible is recommended; if the thread strips, the 3.2mm screw can then be used as a salvage option. Use the smaller 2.0mm drill (P/N ) to prepare for the 2.7mm screws and the larger 2.5mm drill (P/N ) for the 3.2mm screws. Select the correct drill bit as described above, and use the appropriate end of the Drill Guide (P/N ) to drill through the cortices of the bone. FIGURE 8 Push the tip of the Small Screw Depth Gauge (P/N ) through the drilled hole and hook the opposite cortex. Press the barrel of the gauge to the surface of the plate and read the correct screw length. FIGURE 9. FIGURE 9

7 Use the Cruciform Driver (P/N ) or the Hex Driver (P/N ) to pick up the appropriate screw. Press the driver tip firmly into the head of the screw while it is still in the screw caddy. This seats the driver into the screw head and provides retention. FIGURE 10 Verify the screw length with the measuring scale on the caddy. Use the driver to thread the screw into the hole until the screw head is flush with the plate. FIGURE 11 All K-Wires may be removed when the plate is securely fixed. Surgical closure is then performed in the normal fashion. FIGURE 10 SUGGESTED POST-OPERATIVE PROTOCOL GUIDELINES Instruct patients on proper weight bearing until clinical and radiographical evaluation suggest union. Patient noncompliance, nonunion, and/or delayed union can result in failure of the implants. The operating surgeon should consult the Package Insert/Instructions for Use for additional product information. FIGURE 11

8 ORDERING information CHARLOTTE MTP FUSION SYSTEM PART NUMBER DESCRIPTION MTP FUSION, PLATE, STD RIGHT MTP FUSION, PLATE, STD LEFT MTP FUSION, PLATE, EXT RIGHT MTP FUSION, PLATE, EXT LEFT MTP FUSION, PLATE, SM RIGHT MTP FUSION, PLATE, SM LEFT MUC SCREW, 3.0MMX 18MM MUC SCREW, 3.0MMX 20MM MUC SCREW, 3.0MMX 22MM MUC SCREW, 3.0MMX 24MM MUC SCREW, 3.0MMX 26MM MUC SCREW, 3.0MMX 28MM MUC SCREW, 3.0MMX 30MM MUC SCREW, 3.0MMX 32MM MUC SCREW, 3.0MMX 34MM SINGLE TROCAR WIRE, 1.0X150MM SINGLE TROCAR WIRE, 1.6X150MM LOCON T DRILL BIT 2.5MM LOCON T DRILL BIT 2.0MM INSTRUMENTS MTP FUSION, BENDER MTP FUSION, SCREW DEPTH GAUGE MUC SCREW, DEPTH GAUGE (CANN.) MTP FUSION 2.0/2.5 DRILL GUIDE AO QUICK CONNECT, CANNULATED MTP FUSION, CONE REAMER 14MM MTP FUSION, CONE REAMER 16MM MTP FUSION, CONE REAMER 18MM MTP FUSION, CONE REAMER 20MM MTP FUSION, CONE REAMER 22MM MTP FUSION, CONE REAMER 24MM MTP FUSION, CUP REAMER 14MM MTP FUSION, CUP REAMER 16MM MTP FUSION, CUP REAMER 18MM MTP FUSION, CUP REAMER 20MM MTP FUSION, CUP REAMER 22MM MTP FUSION, CUP REAMER 24MM MUC SCREW, 2MM CANN HEX DRIVER SCREW GRIPPER AO DRIVER HANDLE SURGICAL TRAY MTP FUSION, SURGICAL TRAY CHARLOTTE MTP CRUCIFORM PLATE SCREWS/INST. PART NUMBER DESCRIPTION MTP FUSION, SCREW, 2.7MMX 8MM MTP FUSION, SCREW, 2.7MMX 10MM MTP FUSION, SCREW, 2.7MMX 12MM MTP FUSION, SCREW, 2.7MMX 14MM MTP FUSION, SCREW, 2.7MMX 16MM MTP FUSION, SCREW, 2.7MMX 18MM MTP FUSION, SCREW, 2.7MMX 20MM MTP FUSION, SCREW, 2.7MMX 22MM MTP FUSION, SCREW, 2.7MMX 24MM MTP FUSION, SCREW, 3.2MMX 8MM MTP FUSION, SCREW, 3.2MMX 10MM MTP FUSION, SCREW, 3.2MMX 12MM MTP FUSION, SCREW, 3.2MMX 14MM MTP FUSION, SCREW, 3.2MMX 16MM MTP FUSION, SCREW, 3.2MMX 18MM MTP FUSION, SCREW, 3.2MMX 20MM MTP FUSION, SCREW, 3.2MMX 22MM MTP FUSION, SCREW, 3.2MMX 24MM MTP FUSION, CRUCIFORM DRIVER CHARLOTTE MTP HEX PLATE SCREWS/INSTRUMENTS PART NUMBER DESCRIPTION MTP FUSION, HEX SCREW, 2.7MMX 8MM MTP FUSION, HEX SCREW, 2.7MMX 10MM MTP FUSION, HEX SCREW, 2.7MMX 12MM MTP FUSION, HEX SCREW, 2.7MMX 14MM MTP FUSION, HEX SCREW, 2.7MMX 16MM MTP FUSION, HEX SCREW, 2.7MMX 18MM MTP FUSION, HEX SCREW, 2.7MMX 20MM MTP FUSION, HEX SCREW, 2.7MMX 22MM MTP FUSION, HEX SCREW, 2.7MMX 24MM MTP FUSION, HEX SCREW, 3.2MMX 8MM MTP FUSION, HEX SCREW, 3.2MMX 10MM MTP FUSION, HEX SCREW, 3.2MMX 12MM MTP FUSION, HEX SCREW, 3.2MMX 14MM MTP FUSION, HEX SCREW, 3.2MMX 16MM MTP FUSION, HEX SCREW, 3.2MMX 18MM MTP FUSION, HEX SCREW, 3.2MMX 20MM MTP FUSION, HEX SCREW, 3.2MMX 22MM MTP FUSION, HEX SCREW, 3.2MMX 24MM MTP FUSION, STRAIGHT HEX DRIVER Wright Medical Technology, Inc Cherry Road Memphis, TN Wright Medical EMEA Atlas Arena, Australia Building Hoogoorddreef BA Amsterdam the Netherlands Wright Medical UK Ltd. Unit 1, Campus Five Letchworth Garden City Hertfordshire SG6 2JF United Kingdom (0) Trademarks and Registered marks of Wright Medical Technology, Inc Wright Medical Technology, Inc. All Rights Reserved A_27-Oct-2015