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Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
Sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine
Summary
This is a multicenter, randomized, controlled clinical trial comparing two surgical techniques for the treatment of chronic ankle instability (CAI). CAI is a condition in which the outer ligaments of the ankle remain loose and the ankle continues to give way after repeated sprains, causing pain, swelling, and difficulty with sports and daily activities. About 30-40% of patients who sprain an ankle go on to develop CAI. All patients in this study receive arthroscopic repair of the anterior talofibular ligament (ATFL) - the main ligament on the outside of the ankle - together with an Internal Brace, a high-strength suture tape that provides immediate mechanical reinforcement. In the experimental group, an absorbable type I collagen scaffold (REGENETEN) is additionally wrapped onto the repair to promote the regrowth of ligament-like tissue. Patients in the control group receive the Internal Brace repair alone. Eligible patients are aged 18 to 65 with chronic lateral ankle instability that has not improved with standard non-surgical treatment and in whom the ATFL tissue is of poor quality or a previous repair has failed. Participants are randomly assigned 1:1 to one of the two groups, and treatment is assigned by a central computer-generated schedule stratified by study site. Both groups follow the same standardized surgical steps and the same post-operative rehabilitation program. The main question is whether adding the collagen scaffold leads to better ankle function and stability 12 months after surgery. Patient-reported function, pain, return to sport, MRI evidence of ligament healing, and any complications will be followed for up to 24 months.
Official title: Superior Efficacy of Arthroscopic Bioaugmented Anterior Talofibular Ligament Repair With a Collagen Scaffold Compared With Internal Brace Augmentation: A Single-Center Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
84
Start Date
2026-09
Completion Date
2030-09
Last Updated
2026-10-16
Healthy Volunteers
No
Interventions
Arthroscopic Anterior Talofibular Ligament Repair
Arthroscopic examination and repair of the anterior talofibular ligament (ATFL) using the LassoLoop self-locking suture technique via standard anteromedial and anterolateral portals. The residual ligament is debrided and reattached to its anatomic footprint on the fibula.
Internal Brace Augmentation
Mechanical augmentation of the ATFL repair using a FiberTape high-strength suture tape anchored to the fibula with a bioabsorbable suture anchor and to the talus with a 4.75 mm SwiveLock anchor, providing immediate post-operative stability and protecting the repair during early healing. The Internal Brace system is manufactured by Arthrex.
REGENETEN Bioinductive Collagen Scaffold
Intervention Description (\*) Biological augmentation using a REGENETEN bioinductive, absorbable type I collagen scaffold (Smith \& Nephew) braided onto a TigerTape suture, passed through fibular and talar bone tunnels, and fixed with 4.75 mm SwiveLock anchors. The scaffold has a porous microstructure and aligned fiber orientation that supports host cell migration and tissue ingrowth, gradually degrades over approximately six months, and is replaced by host tendon-/ligament-like tissue.
Locations (1)
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China