Randomized Trial of Achilles Tendon Repair With and Without Collagen Scaffold Augmentation

What this Trial Is About

This research aims to evaluate the clinical effects of adding a collagen scaffold during surgical repair for adults with acute Achilles tendon ruptures. The trial is a prospective, multicenter, randomized controlled study involving 48 participants. It compares standard tendon repair surgery alone to surgery combined with collagen scaffold augmentation. The goal is to see if the scaffold improves tendon healing and function, addressing the challenge that biological healing limits recovery despite advances in surgical techniques. Participants are randomly assigned to one of two groups the intervention group receives standard end-to-end Achilles tendon repair with non-absorbable sutures plus a bioinductive collagen scaffold placed over the repair site and secured with soft tissue anchors the control group undergoes the same surgical repair without the scaffold. Both groups follow the same rehabilitation program divided into four phases protection, early loading, strengthening, and return to function. The surgery is done under general anesthesia, and patients are discharged the day after surgery. During the study, tendon function will be assessed using the VISA-A score at 6 weeks, 3, 6, and 12 months after surgery. Additional measurements include ultrasound evaluations of tendon thickness, blood vessel growth, elasticity, calf muscle strength, ankle motion, and tendon oxygenation. Researchers will also monitor surgical complications and other foot and ankle outcome scores. Participants will be closely followed with scheduled assessments to track healing and recovery over one year.

The Effect of Collagen Scaffold Augmentation in Achilles Tendon Rupture Repair