Charles M Zelen, DPM Nathan Young, DPM Jordon Z Tacktill, DPM

Charles M Zelen, DPM Nathan Young, DPM Jordon Z Tacktill, DPM

Charles M. Zelen DPM - Presenter My disclosure is in the Final AOFAS Mobile App I have a potential conflict with this presentation due to - This clinical study was funded by Tornier I am the Primary Investigator I am on the speakers bureau for Tornier Nathan Young DPM, Co-Author My disclosure is in the final AOFAS Mobile App I have no potential conflicts with this presentation Jordon Z Tacktill, DPM Co-Author My disclosure is in the Final AOFAS Program App I have no potential conflicts with this presentation.

Porcine Soft Tissue Repair Patches have become more common place to provide stability and load sharing during the healing process in tendon and ligament repars of the foot and ankle. The ideal patch will serve as a scaffold for cellular ingrowth that is gradually remodeled by the body's own tissues. Biomechanical testing has shown allogenic and porcine dermis to be the strongest soft tissue repair matrices, providing as much as a twofold increase in load to failure compared to suture alone. The Purpose of this Study is to evaluate the use of a specific porcine reconstructive tissue matrix and assess both safety and efficacy in foot and ankle reconstruction.

This is a retrospective single enter central IRB approved clinical trial A specific porcine reconstructive tissue matrix was used to supplement tendon and soft tissue repairs in foot and ankle surgery The Primary objective of this study is to establish that the tissue matrix is effective in the repair of soft tissue structures of the foot and ankle. The Secondary objective is to demonstrate the safety of this soft tissue patch and reconstructive incorporation in 15 consecutive patients without soft tissue reaction Patients were evaluated Clinically and with Ultrasound after 24 months postoperatively The authors hypothesized that the use of the porcine soft tissue matrix would lead to clinically successful soft tissue repair, without fluid formation or soft tissue reaction being observed

Methods 15 Soft Tissue repairs in the foot and ankle were performed using a porcine soft tissue repair matrix Achilles Tendon Ruptures Peroneal Repairs Posterior Tibial Repairs Patent Population Inclusion criteria Male or Female Greater then 18 years of age Tendon repair with supplementation with porcine graft Exclusions Patients with systemic arthritis or inflammatory arthritis History of soft tissue infection to surgical site Immunocomprimsed State

All 15 Soft Tissue Tendon Repairs healed without complications No AE s or SAE s noted No complications related to the soft tissue patch All 15 patients reported good -excellent results 25 20 15 10 5 Complications No Complications 0 Complications

Ultrasound No Fluid signal noted All tendons showed normal signal to tendon and soft tissue repair No recurrent tears noted 20 15 10 5 No Fluid Signal Fluid Signal 0 Fluid Around Tendon

A 70-year-old female presented with pain and weakness of the left lower extremity after sustaining a fall. Clinically there was absence of plantarflexion and a positive Thompson's test X-rays showed a clear avulsion of the Achilles was identified Porcine Soft Tissue Matrix was used to reinforce the repair The above radiographs show the patient intra-operatively and after repair with soft tissue matrix reinforcement

A 70-year-old female presented with pain and weakness of the left lower extremity after sustaining a fall. Porcine Soft Tissue Matrix was used to reinforce the repair >24 month follow up illustrates excellent result with no fluid or abnormality of the Achilles Ultrasound and Clinical Photograph of Achilles repair greater then 24 months after surgery illustrating a normal signal, no pathology, re -tear or fluid noted.

Soft Tissue Repair Matrices Clearly provide biomechanical strength to a tendon and soft tissue repair of the foot and ankle resisting loads nearly twice as much as a repair without reinforcement Historically prior xenograft soft tissue patches have been associated with sometimes extreme soft tissue reactions. Intestinal Submucosa grafts Equine Pericardial grafts Newer Technology and Processing Techniques have allowed for creation of xenografts that are void of an antigenic response after human implantation and are regenerative in nature becoming one with the tendon during the healing process.

In our small series of patients the porcine grafts utilized showed universal safety and efficacy in all the patients studied No complications associated with the grafts both subjectively and objectively confirmed with Ultrasound Further studies and larger prospective trials should be considered to confirm these findings Foot and Ankle Specialists should consider soft tissue repair matrices as a supplement to tendon and soft tissue repair in foot and ankle Surgery for stronger repair and faster return to activity

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