Safety Profile of Artelon Use for Soft Tissue Reconstruction in Foot and Ankle Surgery

CATEGORY: Basic Sciences/Biologics; Ankle; Hindfoot; Midfoot/Forefoot; Sports INTRODUCTION/PURPOSE: Artelon is a synthetic degradable polyurethaneurea graft which has been investigated and utilized for soft tissue reconstruction in a variety of orthopaedic settings. However, in the field of foot and ankle surgery, there is very limited reported clinical data on outcomes of surgery utilizing Artelon. The goal of this study was look at outcomes of foot and ankle surgery in which Artelon is used, including post-op VAS scores and complications including adverse foreign body reaction, infection, repeat surgery, and implant failure. Our hypothesis was that soft tissue reconstruction procedures utilizing artelon will have a low complication rate, similar to established complication rates for other soft tissue reconstruction procedures such as those utilizing allograft, autograft, or other synthetic tissue. METHODS: The treating surgeon’s first 55 consecutive patients 18 years and older who were treated with artelon graft as part of a foot and ankle surgery are being included in this IRB-approved study. Through retrospective chart review, outcome measures including the procedure for which artelon was utilized, pre and post-op Visual Analogue Scale (VAS) scores, and complications including repeat surgery for graft failure, foreign body reaction, wound healing issues, infection, and osteolysis were assessed. Statistical analysis was done utilizing Student’s t-test for continuous variables and chi square test for categorical variables. RESULTS: Average follow-up time was 246.5 days. The majority of patients had artelon placed for spring ligament reconstruction, brostrom procedures, or achilles tendon reconstruction. VAS scores dropped significantly from before surgery to 3 weeks post- operatively (5.6 to 3.2, p<0.05). VAS scores stabilized after 3 weeks, with final follow-up score at 2.9. There were no reports of osteolysis in the area of the graft placement, adverse foreign body reaction, or episodes of graft failure. There were two major complications involving artelon surgical sites: one patient required a free flap for wound coverage, and another required an operative debridement with hardware and artelon removal, antibiotic spacer placement, and subsequent hindfoot fusion. Other minor complications not requiring operative intervention included cellulitis (3 patients) and delayed wound healing (5). CONCLUSION: Artelon is a safe and effective implant that can be utilized for soft tissue reconstruction in the foot and ankle, with similar post-operative pain recovery and wound complication rates compared to established historical data for these procedures. Additional studies must be done looking at long-term patient outcomes with utilization of artelon, and direct comparative studies with other soft tissue reconstruction techniques and materials in the foot and ankle.