Contents. Design Rationale Surgical Goals System Basics

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2 Contents Preface 3 Chapter Chapter Chapter 3 11 Appendix A 12 Appendix B 13 Appendix C Introduction Design Rationale Surgical Goals System Basics CHARLOTTE CAROLINA Jones Surgical Technique Identification and Incision Identify Crucial Anatomy and Place K-wire Tap and Measure Install Screw Mini IGNITE Graft Surgical Technique Iliac Crest Bone Marrow Aspirate Surgical Technique Bone Marrow Aspirate Surgical Technique Ordering Information CHARLOTTE CAROLINA Jones Fracture System Surgical Technique 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 Introduction Preface Designed in conjunction with: Robert Anderson, MD OrthoCarolina, Charlotte, NC Treatment of Jones Fractures has been a notoriously difficult challenge for the Foot and Ankle specialist. The CHARLOTTE CAROLINA Jones Fracture System has been designed in accord with state-of-the-art research and modern clinical methods. James Nunley, MD Duke University Durham, NC W. Hodges Davis, MD Bruce Cohen, MD Carroll Jones, MD OrthoCarolina, Charlotte, NC CHARLOTTE CAROLINA Jones Fracture System 3

4 Design Rationale chapter 1 Surgical Goals To create the screw entry point high and inside on the proximal fragment, allowing proper intramedullary screw placement. To implant a screw with excellent strength, distal bite and compression in order to ensure stability across the fracture site. To minimize screw prominence issues by utilizing a low-profile head. System Basics All screws are manufactured from solid-core surgical grade stainless steel for maximum strength, stiffness and fatigue life. Screws are available in 4.5, 5.5 and 6.5mm diameters from 40 to 70mm in length. The instrument set includes: 3.2mm Cannulated Drill (P/N ) and 3.2mm Solid-core Drill (P/N ). 4.5, 5.5 and 6.5mm Cannulated Taps (P/N , , ). Each Tap (and corresponding screw) has the same thread pitch, only the diameter differs so that the Taps may be used in series without damaging the bone thread path. 2.0mm Tissue Protector (P/N ) for use with the K-wire. 4.5mm Tissue Protector (P/N ) for use with Drill and 4.5mm Tap. 5.5mm Tissue Protector (P/N ) for use with 5.5mm Tap. Universal Tissue Protector (P/N ) for use with all Taps, Drills and Drivers. Percutaneous Bone Grafting Use of mini IGNITE Power Mix should be considered with the CHARLOTTE CAROLINA Jones Fixation System. IGNITE Injectable Stimulus for Small Bone Fracture Callus Formation is designed to percutaneously graft a fracture site through an 11 gauge needle, preserving the periosteal blood supply. The combination of osteoinductive demineralized bone matrix, osteoconductive calcium sulfate and osteogenic progenitor cells from the patient allows a healing response at the fracture site. 4 Chapter 1 Design Rationale

5 Surgical Technique chapter 2 Presented by Robert Anderson, MD and James Nunley, MD Patient Setup and Surgical Planning It is helpful to have a drill handpiece with a Hudson-style adapter. If one cannot be obtained, the adapter (P/N ) may be used in a standard Jacobs chuck. Figure 1 Perform surgery under regional block anesthesia. A tourniquet is usually used to provide a bloodless field, especially when an open technique is used. Position patient supine with a bump under the ipsilateral hip so that the body is rotated towards the side of the operating room table that corresponding to the non-affected foot. Make sure that the ipsilateral knee can be flexed so that it may be placed plantigrade on the edge of the table or sterile operating room fluoroscopy unit. Figure 1 Figure 2 Place a K-wire (P/N ) on the lateral aspect of the foot and use fluoroscopy to position the pin overlapping and parallel to metatarsal shaft. This position should correspond to the target screw placement on both AP and lateral images. Trace two lines on the skin that corresponding to the pin alignment in both views. Figure 2 Chapter 2 CHARLOTTE CAROLINA Jones Fracture System 5

6 Approach and K-wire Placement Figure 3 Make a 1-2cm extensile incision approximately 2cm proximal to the base of the 5th metatarsal. Identify and protect the sural nerve and peroneus brevis tendon. Using the K-wire tissue protector (P/N ) insert the K-wire high and inside on the base of the 5th metatarsal. Figure 3 The K-wire will be opposed to the lateral aspect of the cuboid. Use fluoroscopy to direct the tip of the pin into the center of the intramedullary canal (continuously checking AP, lateral and oblique views). Advance the pin to 1/2 the length of the shaft, or at a minimum just past the fracture line. To prevent deviating medially, the proximal end of the pin should lie against the lateral calcaneal skin while being advanced. Figures 4 and 5 Figure 4 Figure 5 6 Chapter 2 CHARLOTTE CAROLINA Jones Fracture System

7 Figure 6 Using the 4.5mm drill tissue protector (P/N ) and continuous fluoroscopic guidance, advance the cannulated drill (P/N ) avoiding penetration of the 5th metatarsal cortex. Figures 6 and 7 Because the 5th metatarsal is not a straight bone, the guide wire may tend to curve; this will limit advancement of the drill. In this case, redirect the wire prior to further drilling. Figure 7 ALTERNATIVE DRILLING TECHNIQUE Use the cannulated drill to enter the proximal cortex only. Remove the K-wire and drill with the solid 1/8 drill (P/N ) advancing continuously under fluoroscan until proper depth is obtained. Use of this technique decreases the risk of perforation or damage to the K-wire or cannulated drill. Chapter 2 CHARLOTTE CAROLINA Jones Fracture System 7

8 Tap and Measure The tap should be advanced through the straight portion of the distal fragment in A/P and lateral views; care should be taken not to advance into the curved portion, which could malreduce the fracture. Figure 8 Using the 4.5mm cannulated tap (P/N ) and 4.5mm tissue protector (P/N ), tap to the intended screw length. (Figure 8) The tap can be considered a trial since the profile of the tap is the same as the screw. The tap should feel snug within the intramedullary canal; if diameter is undersized, tap to the next size screw using the 5.5mm cannulated tap (P/N ) and 5.5 tissue protector (P/N ). Check under fluoroscan. Continue sequentially tapping with the 6.5mm cannulated tap (P/N ) and 6.5mm/universal tissue protector (P/N ) if necessary. Figure 8 Alternatively, the universal tissue protector may be used for drilling, tapping and screw insertion steps. Figure 9 Correct tissue protector placement. Figure 9A Incorrect tissue protector placement can lead to inaccurate screw measurement. Figure 10 When the correct tap is in the desired position, measure screw length from the grooves in the tap against the tissue protector. Check with fluoroscopic imaging to be sure the angled tip of the tissue protector is seated securely against the proximal 5th metatarsal bone. Figures 9, 9A and 10 8 Chapter 2 CHARLOTTE CAROLINA Jones Fracture System

9 Figure 11 ALTERNATIVE MEASURING TECHNIQUE The guide pin may be used to measure screw length. If using the guide pin to measure screw length, guide pin must be advanced until its tip approximates the location of the tip of the screw. Use the depth gauge (P/N ) to determine screw length. Figure 11 2ND ALTERNATIVE MEASURING TECHNIQUE Figure 12 Place a screw of the estimated length on the lateral side of the foot and check with fluoroscopic imaging that the proper length was chosen. This is especially helpful when the fracture is quite distal to confirm that all the threads are distal to the fracture line. Figure 12 Chapter 2 CHARLOTTE CAROLINA Jones Fracture System 9

10 Install Screw Obtain the correct screw diameter and length. Using the hex driver (P/N ), insert screw until fully engaged. Use fluoroscan to check final screw placement. Figures 13 and 14 Figure 13 Figure CHARLOTTE Chapter 2 CHARLOTTE Carolina Jones CAROLINA Fracture Jones SystemFracture System

11 chapter Surgical Chapter Technique 13 Jones Title Fracture IGNITE Graft Presented by Robert Anderson, MD Ortho Carolina, Charlotte, NC Step One Stabilize Fracture With Hardware Fracture/nonunion must have stable fixation prior to mini IGNITE Graft injection. Placement of the CHARLOTTE CAROLINA Jones Screw is shown. Refer to the CHARLOTTE CAROLINA Jones Fracture System surgical technique for a recommended step-by-step technique on placement. Step Two Localize Defect Under Fluoro Using the blue delivery needle with trocar (supplied in the mini IGNITE Power Mix kit), localize the defect site distal to the screw insertion site. Confirm placement under fluoroscopic guidance. Step Three Create Extra-Cortical Envelope Maintaining needle placement, replace the trocar with the supplied mini IGNITE periosteal elevator. With a gentle sweeping motion, bluntly dissect between bone and soft tissue to create a envelope to receive the IGNITE Graft and bridge the defect. NOTE: INJECTION TIME after mixing marrow and IGNITE powder is approximately 5 MINUTES. Step Four Mix and Inject Maintain needle placement. After aspirating 4cc of red marrow (see Appendix A/B), mix thoroughly according to instructions provided with the kit. Dock syringe onto the pre-placed needle and slowly inject the mini IGNITE Power Mix Graft. Step Five Allow to Coagulate for 3 5 Minutes and Remove Needle Slowly Following injection, maintain needle placement for 3-5 minutes to allow material to coagulate and minimize backflow. Chapter 31 IGNITE Description Graft of Surgical SectionTechnique 11

12 Iliac Ordering Crest Bone Information Marrow Aspirate Appendix A Anterior Approach Medical Health Center, Denver, CO Step One Prepare Site Prep and drape site as for iliac crest graft harvest. Palpate the anterior iliac crest. Placement 1cm posterior to the anterior superior iliac spine will avoid damage to the lateral femoral cutaneous nerve of the thigh. Step Two Insert Needle Introduce the aspiration needle into the central portion of the crest taking care to avoid penetrating the lateral overhanging lip. Step Three Prepare for Aspiration Remove the trocar and place the aspiration syringe on to needle. NOTE: Bone marrow aspiration should be completed after site preparation. See mixing instructions for more details. Step Four Aspirate Bone Marrow Begin aspiration of red marrow. If marrow does not aspirate easily, reposition needle slightly. If marrow still does not aspirate, redirect needle by removing syringe, replacing the trocar and following steps 1-3. Step Five Redirect, Continue Aspiration Redirect needle every 2cc during aspiration to avoid aspirating peripheral blood. The mini IGNITE kit includes diluent for reconstituting the IGNITE powder. The operating medical professional has the option of reconstituting the powder using the included diluent or patient s own bone marrow aspirate (BMA). The selection of patient s own BMA or the included diluent is the responsibility of the operating medical professional. 12 CHARLOTTE Iliac Appendix Crest Bone A Iliac Marrow CAROLINA Crest Aspirate Bone Jones Marrow Fracture Anterior Aspirate System Approach

13 Bone Marrow Aspirate Alternative Bone Marrow Harvest Sites Presented by Steve Brigido, DPM Coordinated Health, East Stroudsburg, PA Appendix B NOTE: Mesenchymal stem cell concentrations are not well understood in these sites. Care should be taken to redirect the needle frequently (every cc) to ensure a quality aspirate harvest. Proximal Tibia Using the ported 11G aspiration needle from the mini IGNITE Power Mix kit, insert the needle into the anterior medial proximal metaphysis at a 30 angle taking care to avoid the distal aspect of the patellar tendon laterally and the distal insertion of the medial collateral ligament medially. Begin aspiration redirecting the needle every ccs. Distal Tibia Using the ported 11G aspiration needle from the mini IGNITE Power Mix kit, insert the needle into the medial face of the tibia at the distal metaphysis. The needle is inserted at a 30 angle, and when inserted properly there are no neurovascular structures to avoid. Begin aspiration redirecting the needle every ccs. Calcaneous Using the ported 11G aspiration needle from the mini IGNITE Power Mix kit, insert the needle into the wall of the lateral calcaneal body at a 30 angle taking care to avoid the sural nerve and the peroneal tendon complex. Begin aspiration redirecting the needle every ccs. The mini IGNITE kit includes diluent for reconstituting the IGNITE powder. The operating medical professional has the option of reconstituting the powder using the included diluent or patient s own bone marrow aspirate (BMA). The selection of patient s own BMA or the included diluent is the responsibility of the operating medical professional. The alternative bone marrow harvest sites shown are optional at the discretion of the medical professional based on individual patient needs and circumstances. These alternative harvest sites are not intended to replace or change standard surgical procedures and techniques. CHARLOTTE Appendix B Bone CAROLINA Marrow Aspirate Jones Fracture System 13

14 Ordering Information Appendix C CHARLOTTE CAROLINA Jones Fixation System KIT1/A Part Number Description Qty Screw 4.5 x 40mm Screw 4.5 x 45mm Screw 4.5 x 50mm Screw 4.5 x 55mm Screw 4.5 x 60mm Screw 4.5 x 65mm Screw 4.5 x 70mm Screw 5.5 x 40mm Screw 5.5 x 45mm Screw 5.5 x 50mm Screw 5.5 x 55mm Screw 5.5 x 60mm Screw 5.5 x 65mm Screw 5.5 x 70mm Screw 6.5 x 40mm Screw 6.5 x 45mm Screw 6.5 x 50mm Screw 6.5 x 55mm Screw 6.5 x 60mm Screw 6.5 x 65mm Screw 6.5 x 70mm Drill 3.2mm Cannulated Drill 3.2mm Solid K-Wire 2.0 x 228mm 4 14 CHARLOTTE Appendix C Ordering CAROLINA Information Jones Fracture System

15 Appendix C CHARLOTTE CAROLINA Jones Distal Thread Lengths Overall Screw Length (mm) Distal Thread Length (mm) CHARLOTTE CAROLINA Jones Fixation Instruments Part No. Description Qty Quick Connect Handle Quick Connect Adapter Hex Driver 3.5mm Tissue Protector 4.5 Drill/Tap Tissue Protector 5.5 Tap Tissue Protector 6.5 Tap/Universal Tissue Protector K-Wire Screw Tap 4.5mm Cannulated Screw Tap 5.5mm Cannulated Screw Tap 6.5mm Cannulated Depth Gauge Surgical Tray (thermoform) 1 Devices with lumens require moistening with distilled or demineralized water before sterilization. ANSI/AAMI ST79:2006: Comprehensive guide to steam sterilization and sterility assurance in health care facilities. Appendix CHARLOTTE C Ordering CAROLINA Information Jones Fracture System 15

16 ordering information 876P-0400 mini IGNITE Power Mix 4cc - Injectable Stimulus for Small Bone Fracture Callus Formation mini IGNITE Power Mix - Injectable Stimulus for Small Bone Fracture Callus Formation Surgical Technique - SK Wright Medical Technology, Inc Airline Road Arlington, TN USA phone toll-free Wright Medical EMEA Krijgsman DM Amstelveen The Netherlands Trademarks and Registered marks of Wright Medical Technology, Inc Wright Medical Technology, Inc. All Rights Reserved. SO Rev.05.10