STS. Subtalar Spacer System SURGICAL TECHNIQUE

Transcription

1 STS Subtalar Spacer System SURGICAL TECHNIQUE

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3 Contents Chapter 1 4 Introduction 4 Device Description Chapter 2 5 Intended Use 5 Indications Chapter 3 6 Surgical Technique 9 Postoperative Protocol 9 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 (152232) 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 Introduction chapter 1 Device Description STS manufactured by Wright Medical Technology is available in various sizes. Concaved distal entrance into guide wire opening to allow self centering of guide pin for removal Space between the four promixal and three distal threads to allow soft tissue encapsulation to minimize migration Larger range of sizes 6.5mm 11.5mm (diameter); 25mm (length) STS Implant Sizes 6.5mm 7.5mm 8.5mm 9.5mm 10.5mm 11.5mm 4 Chapter 1 Introduction

5 Intended Use chapter 2 Indications The STS Screw is indicated for use in treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the posterior and inferior displacement of the talus, thus allowing normal subtalar joint motion while blocking excessive pronation and the resulting sequel. It is appropriate for the following conditions: Severely pronated foot Walking intemperance Calcaneal stance positon greater than 5 Manually correctable deformities Mid-tarsal breech (arch pain) Forefoot varus greater than 10 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 STS Surgical Procedure A linear incision of 2 to 3cm in the relaxed skin attention lines over the sinus tarsi is created, just superior to the peroneal brevis tendon. The incision is deepened by a sharp dissection through the dermis and into the subcutaneous tissue only. Be aware of and avoid the intermediate dorsal cutaneous nerve at the end of the superior aspect of the incision. FIGURE 1 FIGURE 1 A hemostat is then used to bluntly dissect the sinus tarsi. The dissection occurs on the inferior-most portion of the incision and along the floor of the sinus tarsi. The STS probe is then placed in this portal and advanced from lateral to medial in the sinus tarsi. The interosseus talar calcaneal ligament need not be visualized, nor should it be sectioned. The superior aspect of the calcaneus in the floor of the sinus tarsi may be visualized superior to the peroneal brevis tendon. A sinus tarsectomy is not performed. FIGURE 2 FIGURE 2 6 Chapter 3 Surgical Technique

7 The STS guidewire is then placed with the use of the handle for the guidewire from lateral to medical into the channel created by the STS Probe. The guidewire is advanced from lateral to medial until it can be palpated below the surface of the skin. The guidewire exits the sinus tarsi medially, just inferior and anterior to the tip of the medial malleolus. A medial incision, to advance the guidewire through the medial stab incision, is done at the surgeon s preference or discretion. FIGURE 3 FIGURE 3 The guidewire is then left in place coursing through the sinus tarsi. The STS system sizers can then be placed over the guidewire into the sinus tarsi. Sizes are as follows: 6.5, 7.5, 8.5, 9.5, 10.5, and 11.5mm. The sizers are placed over the guidewire into the sinus tarsi and the subtalar joint is then moved through a range of motion. The appropriate size is determined when the calcaneus everts to perpendicular or 2 to 3 degrees valgus. At this point, there should be an end fill or blocking of the subtalar pronation or calcaneal valgus position. FIGURE 4 FIGURE 4 PROFEMUR Chapter 3 RAZ Surgical Total Technique Hip System 7

8 The sizer is then removed and the corresponding trial implant can be placed over the guidewire into the sinus tarsi at the surgeon s discretion. With the appropriately sized implant determinted, the STS implant is placed over the guidewire, and with the assistance of the screwdriver, the implant is screwed into the sinus tarsi and its soft tissue components, including the interosseus talocalcaneal ligament. The implant is screwed into the sinus tarsi in a clockwise direction. The surgeon may then place a free elevator or his thumb against the lateral wall of the calcaneus just inferior to the incision. FIGURE 5 FIGURE 5 The implant is then advanced until it is approximately 1cm into the sinus tarsi from the lateral wall of the calcaneus, as determined by the 1cm mark on the screwdriver. The leading edge of the implant (tip) should be at the longitudinal bisection of the talas. An intraoperative C-arm or radiograph maybe obtained to determine accurate positioning of the STS implant at the surgeon s discretion. FIGURE 6 FIGURE 6 With accurate position of the STS implant obtained, the screwdriver is carefully removed from the implant and the sinus tarsi. The guidewire is also carefully twisted and pulled out of the sinus tarsi. The surgical wound is then irrigated with antibiotic solution as determined by the surgeon. Wound closure is then done at the surgeons preference. 8 Chapter 3 Surgical Technique

9 Postoperative Protocol A postoperative dressing and postoperative shoe or cast-boot, if felt necessary by the surgeon, may then be applied. The patient is then allowed partial to full weight-bearing at the surgeon s discretion. The patient should be significantly restricted in the amount of ambulation done for the first week postoperatively. Beginning with the 2nd or 3rd week postoperatively, the patient is then allowed weight-bearing and ambulation in a tennis shoe with good arch support and/or an orthotic. No physical activity of any kind, running or jumping, should be allowed for a minimum of four weeks postoperatively. The patient is then instructed to gradually return to activity as tolerated. 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. Chapter 3 Surgical Technique 9

10 Ordering Information Appendix A STS Implants 5200KITA PN Description mm mm mm mm mm mm STS Instruments 5200KIT1 PN Description Sizing Probe Sizing Probe Sizing Probe Sizing Probe Sizing Probe Sizing Probe Hex Head Implant Driver 3.5mm CSTS / STS Guide Pin 10 Appendix A Ordering Information

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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 17-Dec-2014