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

"Evaluation of a Biodegradable Synthetic Matrix for Lateral Ankle Ligament Surgical Repair Augmentation: An Open Label Controlled Multicenter Retrospective Review"

“…A degradable biomaterial matrix woven from wet-spun fibers of polycaprolactone based-polyurethane urea (PUUR) provides an augmentation device closer to the elastic modulus of ligament. PUUR textile strips (Artelon Flexband®, Marietta, GA), have been reported for numerous orthopedic soft tissue reconstructive applications [9][10][11][12][13]. PUUR elastomers have an extensive safety record and are widely used biomaterials in catheters, vascular prosthesis, and artificial hearts due to their adaptable mechanical properties and documented biocompatibility [14][15][16][17].…”