Early Clinical Outcomes of a Novel Synthetic Augmentation Device (TEKBRACE) in Ankle Ligament Repair: A Case Series

Abstract

Background

Ligament and tendon pathology of the ankle is frequently complicated by chronic instability, poor tissue quality, and prior failed repairs. Augmentation devices have been introduced to reinforce primary repair and protect healing tissues during the early postoperative period. A novel synthetic augmentation device was used as an adjunct in primary ankle ligament repair across a range of clinical presentations.

Methods

This retrospective case series evaluates early clinical outcomes in 5 patients who underwent ankle ligament repair augmented with TEKBRACE (Theramicro, Cordova, Tennessee). The cohort included 3 males and 2 females with a mean age of 52 years (range, 37-65) and mean body mass index of 29.9 (range, 22.7-39.1). Diagnoses included acute lateral instability (n = 3), acute-on-chronic instability (n = 1), and chronic instability with concomitant tendinopathy (n = 1). All diagnoses were confirmed by clinical examination and magnetic resonance imaging. Mean follow-up was 18 weeks (range, 16-24 weeks). All patients followed a standardized postoperative immobilization and rehabilitation protocol.

Results

At early follow-up, all patients demonstrated stable clinical courses without device-related complications. There were no postoperative infections, wound complications, thromboembolic events, skin reactions, or mechanical failures. Visual Analog Scale pain scores improved from a mean of 4.8/10 preoperatively to a mean of 0.6/10 at final follow-up. Range of motion was within normal limits compared to preoperative baseline in all patients. Four of 5 patients returned to full unrestricted activity. No gross instability was detected on clinical examination at any postoperative visit.

Conclusion

Early outcomes following TEKBRACE augmented ankle ligament repair were encouraging in this small preliminary series, with no device-related complications observed. These findings support the feasibility of the technique and provide rationale for prospective investigation with standardized outcome collection and longer follow-up.