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The Vilex FUZE TM Dual Thread Screw & Intramedullary Nail in One Implant The Ultimate TTC Arthrodesis Internal Fixator Introduction The Vilex FUZETM TTC Arthrodesis Compression Nail combines the attributes of a compression screw and intramedullary nail. The screw feature achieves compression at the talo-tibial joint. The intramedullary nail feature allows the distribution of the patient’s weight through four lateral-medial and two anterior-posterior solid locking screws. The FUZE head is embedded in the calcaneous. In addition, the proximal anterior hole is slanted 45˚ to allow a locking screw from the heel to the talus through FUZE itself. STEP-BY-STEP SURGICAL PROCEDURE PREPARATION AND INCISIONS Patient Positioning Position patient supine on the operating room fluoroscopy table. Thigh tourniquet if needed. Place a roll under the ipsilateral buttocks to maintain neutral rotation of the lower extremity. Prep and drape free the lower extremity up to the thigh tourniquet. Position either a standard or mini-fluoroscopy c-arm unit on the operative side. 1 Incision, Exposure and Joint Preparation 10-15 cm curvilinear incision over the distal third of the fibula extending past the sinus tarsi and subtalar joint. Care to stay away from the superficial peroneal nerve anteriorly and sural nerve posteriorly. Full-thickness dissection. Osteotomize the fibula to rotate out of surgical field. The fibula can also be removed and morselised for use as bone graft for the fusions. Prepare the tibiotalar joint and subtalar joint by removing any remaining cartilage and subchondral bone. Make a second small incision medial to the anterior tibial tendon to expose the medial ankle joint and remove cartilage from the remaining joint surfaces. A laminar spreader can aid in visualization. Translate the talus medially by 1-2cm to insure that the talus and calcaneus are centered with the tibial canal. Resect the soft tissue in the sinus tarsi and remove the cartilage and subchondral bone from the posterior facet of the subtalar joint. Once the joints have been adequately prepared, position the foot with neutral ankle dorsiplantar flexion, 5 degrees of external rotation and 5 degrees of hindfoot valgus. The joints can be temporarily stabilized in this position with the temporarily external fixator included in the FUZE tray or with large pins. Plantar incision to expose the plantar aspect of the calcaneus. Careful blunt dissection through the plantar fascia retracting the neurovascular bundle with Hohman retractors. 2 Use a power driver to insert and advance the 2.5 x 300mm Steinman pin through the plantar aspect of the calcaneus through the talus and into the distal tibial medullary canal. The pin should advance at least 100mm into the tibial canal. Confirm proper placement of the Guide Wire using anteroposterior and lateral fluoroscopy. Using the cannulated 8mm drill bit either with power driver or the FUZE Blue T-Handle, drill up to the level of the distal tibial metaphysis. Visualize the progress of the drill with the aid of fluoroscopy. 3 Remove the drill and remove the Guide Wire. Insert the 2.5mm x 500mm ball/rounded end guide wire into the tibial canal. Verify on both anteroposterior and lateral fluoroscopy the central location of the guide wire. 4 Place the Reamer over the ball/rounded end guide wire and advance it through the calcaneus, talus and into the tibial canal. Increase the reamer sizes until the reamed hole is .5mm larger than the minor diameter of the FUZE implant (as noted in able on next page). Over-reaming the canal will aid the FUZE in advancing through the talar and tibial bone. Ensure that the foot maintains proper position during reaming so malalignment does not occur. 5 Manually compress the foot against the tibia to close the tibiotalar and subtalar gaps. Augment any bone deficits with either autogenous graft or allograft substitutes. 6 Remove the ball/rounded end guide wire and insert the FUZE manually with the attached 5.5mm hex screwdriver. When the distal thread of the implant engages the distal tibia and the head engages the calcaneus, the tibio-talar and talo-calcaneal joints compress. Make sure the middle thread clears the talus and screws into the distal aspect of the tibial plafond. Verify this position under fluoroscopy. NOTE: If using a cannulated version of the FUZE, it can be passed over a straight guide pin. Make sure the ball/bent wire is exchanged for the straight guide wire. If a fracture occurs at the top of the FUZE upon insertion, remove the nail, ream slightly larger and insert a longer FUZE. See FUZE Assembly Chart below. FUZE Assembly FUZE DRIVER LOCKING SCREW ADAPTER T RATCHET HANDLE Reamer Chart Vilex Fuze Nail Sizes (diameter x length) Recommended Reaming Size for FUZE Nail (in order) Reaming/Drill Depth for FUZE 10mm x 150mm 8mm Drill only - no reaming needed 150mm 10mm x 200mm 8mm Drill only - no reaming needed 200mm 10mm x 250mm 8mm Drill only - no reaming needed 250mm 12mm x 150mm 8mm Drill followed by 10.5mm Reamer 150mm 12mm x 200mm 8mm Drill followed by 10.5mm Reamer 200mm 12mm x 250mm 8mm Drill followed by 10.5mm Reamer 250mm 14mm x 150mm 8mm Drill followed by 10.5mm Reamer, followed by 12.5mm Reamer 150mm 14mm x 200mm 8mm Drill followed by 10.5mm Reamer, followed by 12.5mm Reamer 200mm 14mm x 250mm 8mm Drill followed by 10.5mm Reamer, followed by 12.5mm Reamer 250mm Attach Targeting Frame Attach the targeting Frame to the FUZE head. Align the notch of the FUZE implant with the protrusion pin that is located in the middle support bar of the targeting frame. The FUZE screwdriver assembly locks into the targeting frame in only one position. Tighten the locking nut to secure the frame to the FUZE hex screwdriver assembly. 7 Targeting Frame Locked NOTE: The FUZE screwdriver assembly locks into the Targeting Frame in only one position. Tighten the locking nut to secure the Targeting Frame to the FUZE hex screwdriver assembly. Nut Interlocking Screws Placement The FUZE Interlocking screws are solid, fully threaded, 5.0mm diameter ( lengths from 20mm to 130mm) Introduce the interlocking screws. Insert the drill sleeve into the targeting frame hole (proximal hole must correspond to the leading tip of the implant). Use the long Vilex 3.5mm drill to drill bi-cortical through the medial aspect of the tibia, FUZE Nail and lateral aspect of the tibia. This will provide the pilot hole for the interlocking screw. Remove the drill sleeve; place the appropriate length 5.0 solid interlocking screw. Determine the proper length by reading the calibration mark off the drill at the back of the drill sleeve. Alternatively, a sliding depth gauge can be used to determine the proper screw length. Verify under fluoroscopy the appropriate length measured to determine the correct screw length. 8 Optional Anterior Tibial Calcanal Screw An optional anterior tibial calcaneal screw can be placed to achieve additional stability through the fusion sites. An anterior incision should be made along the anterior aspect of the distal tibia corresponding to the site the drill guide/drill meets the anterior skin. 9 Dissect and protect the anterior tendinous and neurovascular structures and advance the drill guide until it hits the bone. This will protect the vital structures during drill and screw advancement. 10 An end cap is provided to close the FUZE cannulation. The Vilex FUZE System Self Drilling and Tapping Leading Tip INDICATIONS • Ankle Arthrodesis • Charcot Foot • Arthritis • Foot Deformity • Trauma FUZE SPECIFICATIONS • FUZE Length: 150, 200, 250 • Thread Diameter: 10, 12, 14 mm • Material: Titanium • Multi-axial stabilization with up to 6 bicortical locking screws • 5.0 mm screws in 20-120 mm lengths • Radio translucent targeting tool • Cannulated implant and instruments Cancellous Tibia Thread Rearfoot Arthrodesis Screw Slant ed 45˚ Threaded Head Cortical Fax: 866-606-4911 E-mail: [email protected] Visit us at www.vilex.com Vilex, Inc. • 111 Moffitt Street McMinnville, TN 37110 USA Phone: 800-521-5002 ©2013 Vilex, Inc. All rights reserved. QSD 8.12-15 REV B