ALLOPURE. Bicortical Allograft Wedges Specific for Evans and Cotton Osteotomies SURGICAL TECHNIQUE

Transcription

1 ALLOPURE Bicortical Allograft Wedges Specific for Evans and Cotton Osteotomies SURGICAL TECHNIQUE

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3 Contents Chapter 1 4 Chapter Chapter Appendix A 9 Introduction Intended Use Indications Contraindications Surgical Technique Cotton Procedure Evans Procedure Explant Information Postoperative Management Ordering Information Wright recognizes that 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, experience, and patient condition. Prior to use of the system, the surgeon should refer to the product Instructions For Use in the package insert for additional warnings, precautions, indications, contraindications and adverse effects. Instructions For Use are also available by contacting the manufacturer. Contact information can be found on the back of this surgical technique and the Instructions For Use package inserts are available on wmt.com under the link for Prescribing Information. Please contact your local Wright representative for product availability. 3

4 Introduction chapter 1 As the leader in foot and ankle surgery, Wright continues to develop cutting edge technologies which help simplify complex surgeries with a goal to improve outcomes. ALLOPURE Bicortical Allograft Wedges provide Foot and Ankle surgeons the simplicity of pulling size specific allograft off the shelf for Evans and Cotton Osteotomies. As a natural cancellous bone construct with two-cortical walls, these wedges are intended to provide a scaffold that supports the ingrowth of new bone. 4 Chapter 1 Introduction

5 chapter Intended Use 2 Indications ALLOPURE Bicortical Allograft Wedges consist of both cancellous and cortical bone shaped into specific sizes. ALLOPURE Bicortical Allograft Wedges are intended to be used for the repair, replacement or reconstruction of musculoskeletal defects by a qualified healthcare professional (i.e., physician). This includes filling bone voids or gaps of the skeletal system (e.g. Evans and Cotton Osteotomies) that are not intrinsic to the stability of the bony structure. ALLOPURE Bicortical Allograft Wedges are supplied in a range of sizes. ALLOPURE Bicortical Allograft Wedges are aseptically processed and packed, preserved by freeze drying, and are terminally sterilized by gamma irradiation. The allografts are for surgical use by licensed clinicians. Contraindications The presence of infection at the transplantation site is a contraindication for use of musculoskeletal allografts. Warnings Human tissue has the potential to transmit infectious agents. Donor screening, processing treatments and laboratory testing follow stringent specifications to reduce the risk of infectious agent transmission. Do not use if the expiration date has been exceeded or if there is evidence of defects in package or label integrity. Do not re-sterilize. It is the responsibility of the hospital or clinician to maintain tissue for transplantation according to recommended storage conditions. Do not use if the tissue has not been stored according to the recommended STORAGE instructions. Chapter 2 Intended Use 5

6 chapter Surgical 3 Technique ALLOPURE Bicortical Allograft Wedge COTTON Procedure STEP 1 EXPOSURE / PREPARATION A linear incision is made exposing the medial cuneiform. Care is taken to avoid disrupting the extensor hallucis longus tendon. The cotton osteotomy is performed in a dorsal to plantar direction across the medial cuneiform and opened using osteotome. FIGURE 1 STEP 2 HYDRATING THE GRAFT Cover the graft with a sterile room-temperature solution: sterile isotonic solution. Submerge the wedge completely to ensure adequate hydration. The graft must remain in the sterile solution for approximately 10 minutes, and until surgically implanted. STEP 3 WEDGE INSERTION Insert the ALLOPURE Bicortical Cotton Wedge FIGURE 2 into osteotomy and impact until the wedge is flush with host bone. FIGURE 3 Adjustments to the ALLOPURE Bicortical Cotton Wedge can be made using a bone rongeur or sagittal saw. Discard of any unused implant in accordance with standard practice for disposal of human tissue. FIGURE 4 STEP 4 FIXATION Fixation is recommended when using an ALLOPURE Bicortical Cotton Wedge. FIGURE 1 FIGURE 2 FIGURE 3 FIGURE 4 6 Chapter 3 Surgical Technique

7 ALLOPURE Bicortical Allograft Wedge EVANS Procedure STEP 1 EXPOSURE / PREPARATION An oblique incision is made centered over the distal lateral calcaneus. FIGURE 1 Care is taken to avoid the intermediate dorsal cutaneous nerve superiorly and the sural nerve inferiorly. Deepen the incision through the superficial facia, exposing the lateral surface of the calcaneus. Using a sagittal saw, make a cut completely through the calcaneus, one centimeter proximal to the calcaneocuboid joint. FIGURE 2 Use a spreader to open the osteotomy, lengthening the lateral column. In order to prevent instability, avoid opening the calcaneocuboid joint. STEP 2 SIZING Insert the 8mm trial and loosen the distractor. FIGURE 3 Verify implant sizing, forefoot correction, and talonavicular coverage fluoroscopically. If further correction is needed, remove the 8mm trial, and insert the 10 or 12mm trial. FIGURE 1 FIGURE 2 FIGURE 3 Chapter 3 Surgical Technique 7

8 STEP 3 HYDRATING THE GRAFT Cover the graft with a sterile room-temperature solution: sterile isotonic solution. Submerge the wedge completely to ensure adequate hydration. The graft must remain in the sterile solution for approximately 10 minutes, and until surgically implanted. STEP 4 WEDGE INSERTION Insert the ALLOPURE Bicortical Evans Wedge into osteotomy and impact until the wedge is flush with the host bone. FIGURE 4 STEP 5 FIXATION Fixation is recommended when using an ALLOPURE Bicortical Evans Wedge. FIGURE 5 FIGURE 4 FIGURE 5 Explant Information If the removal of the implant is required due to revision or failure of the device, the surgeon should contact the manufacturer using the contact information located on the back cover of this surgical technique to receive instructions for returning the explanted device to the manufacturer for investigation. Postoperative Management Postoperative care is the responsibility of the medical professional. 8 Chapter 3 Surgical Technique

9 Ordering Information Appendix A H W L PART NO. DESCRIPTION HEIGHT x LENGTH x WIDTH (MM) LL LL LL LL0006 ALLOPURE Bicortical Evans Wedge 8mm 8 x 20 x 22 ALLOPURE Bicortical Evans Wedge 10mm 10 x 20 x 22 ALLOPURE Bicortical Evans Wedge 12mm 12 x 20 x 22 ALLOPURE Bicortical Cotton Wedge 6mm 6 x 24 x 14 Refer to Instructions For Use included with the product prior to use. Appendix A Ordering Information 9

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12 Distributed by: 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 B 23-Mar-2015