ORTHOFLEX. Silicone Hammertoe Implant SURGICAL TECHNIQUE

Transcription

1 ORTHOFLEX Silicone Hammertoe Implant SURGICAL TECHNIQUE

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3 Contents Chapter 1 4 Product Information 4 Device Description Chapter 2 4 Intended Use 5 Indications 5 Contraindications Chapter 3 6 Surgical Technique 10 Postoperative Protocol 10 Explant Information Appendix A 11 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 package insert for additional warnings, precautions, indications, contraindications and adverse effects. Instructions For Use package inserts 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 Product Information chapter 1 Device Description The ORTHOFLEX is a flexible double stemmed implant specifically designed for the proximal interphalangeal joint of the lateral toes. It is used as an adjunct to resection arthroplasty in hammertoe deformities. E A F A C D B B ORTHOFLEX Rod with Spacer Postoperative X-ray. ORTHOFLEX Implant Dimensions (mm) Implant Description A Thickness B Length C Distal Stem D Proximal Stem E Spacer F Thickness 2.5mm Rod w/spacer mm Rod w/spacer mm Rod mm Rod Chapter 1 Product Information

5 Intended Use chapter 2 Indications The indications for the ORTHOFLEX Rod include: Semi-rigid or rigid hammertoe deformity associated with degenerative arthritis Semi-rigid or rigid hammertoe deformity associated with rheumatoid arthritis Revision of a failed arthroplasty or arthrodesis Contraindications Infection Irreparable tendon system Physiologically or psychologically inadequate patient Inadequate skin, bone, or neurovascular status Growing patients with open epiphyses Possibility for conservative treatment Patients with high levels of activity Prior to use of the system, the surgeon should refer to the product instructions for use package insert for warnings, precautions, indications, contraindications and adverse effects. Instructions for use package inserts 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. Chapter 2 Intended Use 5

6 chapter Surgical 3 Technique A small dorsal incision is made along the dorsal proximal interphalangeal joint. Once the skin is incised, a transverse tenotomy is made. It is important to create a good distal tenotomy flap for closure. An inversion technique closure will be performed, so an adequate distal flap is required. Medial and lateral collateral ligaments to the head of the proximal phalanx are transected. FIGURE 1 FIGURE 1 The head of the proximal phalanx is then removed with a sagital saw or small bone cutting tool. Ensure that the cut is perpendicular to the long axis of the proximal phalanx. FIGURE 2 NOTE: It is crucial at this point to not remove too much of the proximal phalanx. A transverse bone cut just proximal to the distal phalangeal flare of the distal metaphysis is suggested. FIGURE 2 6 Chapter 3 Surgical Technique

7 Any rough areas of bone can be removed with a small ronguer. The toe is then checked for proper reduction. If the toe is still contracted, a sequential release to plantarflex the remaining proximal phalanx is required. FIGURE 3 FIGURE 3 At this point, use the ORTHOFLEX drill provided in the sterile ORTHOFLEX kit to create the hole for implant insertion in the intermediate phalanx. The ORTHOFLEX drill is.2mm larger in diameter than the actual implant. FIGURE 4 FIGURE 4 PROFEMUR Chapter 3 RAZ Surgical Total Technique Hip System 7

8 Next, drill the proximal phalanx using the same ORTHOFLEX drill. It is important to ensure the holes are directly centered in both the proximal and intermediate phalanx. FIGURE 5 FIGURE 5 The longer stem is inserted first into the proximal phalanx and then the shorter stem is inserted into the intermediate phalanx. FIGURE 6 NOTE: The stem ends of the implant can be cut to length if necessary. Care must be taken to not cut too much of the distal stem. If the distal stem is cut too short, there is a risk of implant dislocation under stress flexion. FIGURE 6 8 Chapter 3 Surgical Technique

9 Before closure, it is important to ensure proper spacing of the implant. There should not be significant play or space in the implant to bone interface. You may then approximate the capsular and tendon layer. FIGURE 7 FIGURE 7 For capsular closure, an inverted suturing technique that buries the suture knot into the joint is often used. This will prevent irritation of the suture and prevents suture spit. It also stabilizes and secures the joint space. Again, a proper distal tendinous flap will aide in this closure technique. FIGURE 8 FIGURE 8 Chapter 3 Surgical Technique 9

10 A postoperative X-ray is recommended to confirm proper placement of the implant. Postoperative Protocol Postoperative care is the responsibility of the medical professional. 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. 10 Chapter 3 Surgical Technique

11 Headline Ordering Headline Information Appendix A Implants Kits PN Description mm ORTHOFLEX Rod with Spacer Kit mm ORTHOFLEX Rod with Spacer Kit mm ORTHOFLEX Rod Kit mm ORTHOFLEX Rod Kit Appendix A Ordering Information 11

12 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 05-Dec-2014