Safety Profile of Synthetic Elastic Degradable Matrix for Soft Tissue Reconstruction in Foot & Ankle Surgery.

Abstract

Background: Augmentation of soft tissue repairs has been helpful in protecting surgically repaired tissues as they heal. FlexBand (Artelon, Marietta, Georgia) is a synthetic, degradable, polycaprolactone-based polyurethane urea (PUUR) matrix that has been investigated and used for soft tissue repair in a variety of settings. The purpose of this study was to evaluate the safety profile of a PUUR matrix in a large cohort of patients undergoing soft tissue repairs about the foot and ankle.

Methods: A retrospective chart review of consecutive patients who underwent surgery using FlexBand to augment a soft tissue repair was performed to evaluate for major and minor complications related to the PUUR matrix. Results. A total of 105 patients with an average >6 months follow-up were included. The most common procedures were spring ligament repair, Achilles tendon repair, and Brostrom. There were 12 complications. Four major complications occurred with only 1 requiring PUUR matrix removal. Patients with wound complications had a higher body mass index (BMI) and rate of smoking.

Conclusion: Complication rates involving PUUR matrix in soft tissue foot and ankle reconstruction procedures are low and comparable with historical complication rates. The PUUR matrix is safe for use in a variety of soft tissue procedures about the foot and ankle.Level of Evidence: Level 4, Retrospective case-series.