SURGICAL TECHNIQUE THE TENDON ANCHOR SYSTEM

SURGICAL TECHNIQUE THE TENDON ANCHOR SYSTEM

TABLE OF CONTENTS Introduction PAGE 1 Features and Benefits PAGE 1-2 Applications PAGE 3 Ordering Information PAGE 4 Indications & Contra-indications PAGE 5 Surgical Technique PAGE 6-10 Post-operative Protocol PAGE 11 Clinical Data PAGE 12

Introduction The BioPro Tendon Anchor System is a toothed titanium implant designed for reattachment of soft tissue to bone. The system provides far greater surface compression than is possible with traditional reattachment techniques. The Tendon Anchor System is delivered in sterile packages and includes the anchor, screws and all the instruments needed to implant the system. This approach simplifies inventory and ensures the facility has everything needed to implant the device. This also reduces processing time and cost, eliminating the need for sterile processing of an instrument kit. Features and Benefits Single-hole and two-hole designs available to accommodate tendon size and patient anatomy The hole in the Tendon Anchor allows the screw to pass through the anchor and secure it to the bone. There are two options available, a 10mm wide anchor with one hole, using one screw for fixation, and a 26mm wide anchor with two holes, using two screws for fixation. Additionally, the 2-hole anchor is pre-shaped to fit the contour of the calcaneus. Why is this important? The two available size options allow the Tendon Anchor System to be utilized for a wide variety of procedures, reattaching tendons of varying size. Staggered teeth penetrate the tendon to resist pull through The teeth on the tendon anchor system are arranged in a staggered layout, as opposed to in-line. Why is this important? The staggered teeth allow the anchor to engage more tendon fiber bundles, offering a stronger interface with the tendon. PAGE 1

Blunt teeth won't penetrate bone, preventing over compression of the tendon The tips of the 2mm long teeth are blunt, ensuring they contact the bone, but do not penetrate it. Why is this important? This ensures the anchor s teeth penetrate the tendon for secure fixation, but maintain a 2mm gap between the under surface of the anchor and bone to avoid over compression of the tendon. Earlier ambulation versus traditional suture anchor techniques The 26mm 2-hole Tendon Anchor System offers 188mm 2 of surface area to reattach a tendon and the 10mm 1-hole offers an area of 65mm 2, providing a stronger, more secure interface than traditional suture anchor techniques. Why is this important? The more surface area of the tendon engaged, the better the chance of a successful reattachment and maintaining the integrity of the tendon. This combined with the high pull-out strength of the Tendon Anchor System allows patients to ambulate in a walking boot 7-10 days post-op, versus 6+ weeks with most suture anchor techniques. Ultra thin profile avoids implant prominence The Tendon Anchor System is only 1mm thick, with 2mm long teeth, designed to penetrate the tendon being fixated. The fixation technique compresses the tendon and recesses the anchor at or below the level of the tendon. Why is this important? Due to the Tendon Anchor System s thin profile and tendon penetrating teeth, the anchor will be at or below the surface of the tendon being reattached, reducing or eliminating soft tissue irritation caused by implant prominence. Speed of application reduces OR time Implanting the Tendon Anchor System is quick and easy, much faster than traditional techniques. Why is this important? Traditional suture anchor techniques require sutures to be woven through the tendon in a complex manner to avoid pull-through. This is a time consuming process, compared to the quick application time to implant a Tendon Anchor System. This in turn reduces operating room time and associated complications. PAGE 2

Applications The Tendon Anchor System is indicated for use in any soft tissue to bone attachment procedure, other than spine. Below is a list of specific procedures the system works particularly well for. Haglund s Deformity - Achilles tendon reattachment Kidner Procedure - Posterior tibial tendon reattachment Jones Procedure FHL/EHL transfers Young s Tenosuspension attaching the tibialis anterior tendon Hibbs Procedure EHL transfer Lateral Ankle Stabilization ligament reattachment PAGE 3

Ordering Information The BioPro Tendon Anchor System is manufactured from titanium, offering excellent biocompatibility as well as implant flexibility and strength. The system is delivered sterile, with everything needed for implantation. The 2-Hole Tendon Anchor System includes the anchor, an olive K-wire for temporarily fixation during implantation, two 15mm screws and two 20mm screws, plus a disposable screwdriver. The 1-Hole Tendon Anchor System includes the anchor, one anchor holder, one 15mm screw and one 20mm screw, plus a disposable screwdriver. Multiple screw lengths are included with the system to ensure good screw purchase and strong fixation during implantation. Item # Description Size 20070 Tendon Anchor System 1-Hole 10mm 20159 Tendon Anchor System 2-Hole 26mm 1-Hole Tendon Anchor System Kit 2-Hole Tendon Anchor System Kit Holder & 1-Hole TAS 0.045 olive K-wire 2-Hole TAS TAS Driver (1) 15mm Screw & (1) 20mm Screw TAS Driver (2) 20mm Screws (2) 15mm Screws PAGE 4

Indications The BioPro Tendon Anchor System is indicated for use for soft tissue to bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow, and shoulder. The BioPro Tendon Anchor System is supplied sterile and intended for single-use only. Contraindications 1. A general health problem that might pose a significant threat to the life of the patient if subjected to a major surgical procedure. 2. An active infection or a previous infection of the lower extremity that has not been quiescent for at least six months. 3. A local or systemic infection. 4. Significant deficiency in the vascular supply to the extremity. 5. Severe structural deficiency of the sub-chondral bone that may result in insufficient support for the device. 6. Severe compromise of the supporting muscles or ligaments about the fracture. 7. It is not intended for use in the spine. CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Note: This implant should not be used in patients with a known sensitivity to titanium. Use of longer screws could result in irritation and violation of adjacent joint spaces resulting in pain and discomfort. PAGE 5

Surgical Technique Fig. 1 Surgical Technique For Haglund s Deformity The following steps detail the technique for use of the Tendon Anchor System for reattaching the Achilles tendon during a Haglund s correction procedure. This technique for implanting the anchor may be applied to any soft tissue to bone application. Step One With the patient in the prone position, an incision centered over the Achilles tendon is made posteriorly (Fig 1). Fig. 2 Step Two The incision is carried down to the calcaneus and calcaneal tendon insertion. A midline incision is now made into the Achilles tendon, full thickness, from posterior to anterior (Fig 2). Fig. 3 Step Three The Achilles tendon is released distally, and reflected medially and laterally, exposing the whole calcaneal tuberosity with a Haglund s prominence. Thoroughly debride the Achilles of all tendinopathic tissue. Care is taken to maintain some medial and lateral attachments to assist with the accurate restoration of the Achilles length. Complete tendon debridement may require complete tendon detachment in some cases (Fig 3). PAGE 6

Fig. 4 Step Four Excise the bursa and remove the Haglund s prominence using a micro-sagittal saw and osteotome (Fig 4). If present, remove any posterior calcaneal spurs and remodel as necessary. Step Five Fig. 5 The posterior aspect of the calcaneus is remodeled utilizing a reciprocating rasp so as not to leave a prominence, palpable under the skin, creating difficulties with footwear (Fig 5). Next, the Achilles tendon is re-approximated with a braided non-absorbable suture of choice. Care is taken to bury the suture knots. Fig. 6 Step Six Next, with the Achilles tendon at the desired insertion point on the calcaneous, the Tendon Anchor System is placed over the tendon and temporarily secured into place with the provided Olive K-wire (Fig 6). Pre-drill both screw holes with a 0.062 K-wire to ensure accurate screw placement. Note: This technique involves using the 26mm 2-hole Tendon Anchor System. If this anchor doesn t fit the patient s anatomy properly, use two 10mm 1-hole Tendon Anchors. PAGE 7

Fig. 7 Step Seven The Tendon Anchor System is then permanently secured with the provided self-drilling, self-tapping screws. Care is taken not to over tighten the screws and risk stripping the bone (Fig 7). Note: The system includes both 15mm and 20mm screws. It is recommended to secure the anchor with the 15mm screws initially. If sufficient screw purchase cannot be attained, replace them with the 20mm screws. Fig. 8 Step Eight All temporary instrumentation is removed. The subcutaneous tissues and skin are closed per surgeon s preference (Fig 8). PAGE 8

Fig. 1 Surgical Technique For Kidner Procedure Step One A linear longitudinal incision is made over the horizontal midline of the navicular (Fig 1). Fig. 2 Step Two The incision is carried down to the navicular through the capsule, exposing the posterior tibial tendon (Fig 2). Fig. 3 Step Three The posterior tibial tendon is released and any tendinopathic tissue is removed. Sharply excise the accessory navicular (if present) with the surgeon s preferred method. Free the surface of the navicular of soft tissues and rasp the area smooth (Fig 3). PAGE 9

Fig. 4 Step Four With the foot in STJ neutral or slightly inverted, position the posterior tibial tendon in the desired tension on the navicular, place the 10mm 1-Hole Tendon Anchor over the tendon. Note: Pre-drill the desired screw placement with a 0.062 K-wire. Secure with one of the included self drilling/self tapping screws. Care is taken not to over tighten the screws and risk stripping the bone (Fig 4). Note: The system includes a 15mm and 20mm screw. It is recommended to secure the anchor with the 15mm screw initially. If sufficient screw purchase cannot be attained, replace it with the 20mm screw. Fig. 5 Step Five The subcutaneous tissues and skin are closed per the surgeon s preference (Fig 5). 0086 PAGE 10

Post-operative Protocol Immediate post-op, patient is placed in a modified Jones compressive dressing and a non-weight bearing fiberglass posterior splint. First postoperative visit, post-op day four, the dressing is changed and incision is examined. Continue with the non-weight bearing posterior splint. Second postoperative visit, post-op day seven, a modified Jones compressive dressing as well as a walking boot are applied. Patient is allowed to bear weight as tolerated. Patient to remain in a walking boot for a total of four weeks. At four weeks post-op, patients are gradually weaned off the walking boot and may progress to regular shoe gear as tolerated. Physical therapy may be considered at this time. PAGE 11

Study Evaluation of a New Device for the Reattachment of the Achilles Tendon Jill S. Kawalec-Carroll, PhD Objective The objective of this study was to evaluate the performance of a new device for the reattachment of the Achilles tendon. The new device consisted of an anchor and two screws. Method Five matched pairs of fresh frozen lower limb specimens were used in this study. These included four female and one male ranging from 44-87 years in age. Dissection was performed on each limb to expose the posterior portion of the calcaneus and to isolate the Achilles tendon. The Achilles tendon was then detached at the calcaneus and reattached for testing. Results The maximum loads to failure obtained with the Tendon Anchor System reattachment were consistently greater than those measured with the suture anchor reattachment. As shown in Figure 1, the average maximum load to failure measured with the Tendon Anchor System reattachment was approximately 3 times greater than that measured with the suture anchor reattachment. PAGE 12

www.bioproimplants.com +1-810-982-7777 info@bioproimplants.com 2929 Lapeer Road Port Huron, MI 48060 www.bioproimplants.com Brochure No. 20201 rev 04