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REAR
Superior Efficacy of Arthroscopic Bioaugmented Anterior Talofibular Ligament Repair With a Collagen Scaffold Compared With Internal Brace Augmentation: A Single-Center Randomized Controlled Trial
Sponsor study identifier
interventional
84
1 country
1
Study Start
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 11, 2026
Actual (reported)October 16, 2026
Actual (reported)September 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change from Baseline in Karlsson-Peterson Ankle Function Score at 12 Months
The Karlsson-Peterson ankle function score (range 0-100, higher = better) assesses subjective symptoms (30 points), objective clinical findings (30 points), and activity level (40 points). The change from baseline is calculated as the 12-month score minus the pre-operative score. The between-group difference (bioaugmentation vs. mechanical augmentation only) is compared using a superiority framework.
12 months post-operatively
FAOS Subscale Scores
3, 6, 12, and 24 months post-operatively
FAAM-ADL Score
3, 6, 12, and 24 months post-operatively
Arthroscopic ATFL repair combined with Internal Brace mechanical augmentation and REGENETEN collagen scaffold bioaugmentation. The REGENETEN scaffold is braided onto a TigerTape suture and fixed through fibular and talar bone tunnels with 4.75 mm SwiveLock anchors.
Arthroscopic ATFL repair combined with Internal Brace mechanical augmentation (FiberTape fixed with bioabsorbable anchors and 4.75 mm SwiveLock anchors) but without REGENETEN bioaugmentation.
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.
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Karlsson J, Peterson L. Evaluation of ankle joint function: the use of a scoring scale. The Foot. 1991;1(1):15-19.
Zongyou Pan, MD
Second Affiliated Hospital, Zhejiang University, School of Medicine
First Submitted
October 11, 2026
First Posted
October 16, 2026
Study Start
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
FAAM-Sports Score
3, 6, 12, and 24 months post-operatively
Tegner Activity Scale Score
3, 6, 12, and 24 months post-operatively
NRS Pain Score at Rest and After Activity
Each follow-up visit (3, 6, 12, and 24 months post-operatively)
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.
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.
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Primary Completion
September 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 16, 2026
Record last verified: 2026-09
De-identified individual participant data will not be publicly shared. Access to the de-identified dataset may be considered upon reasonable request to the principal investigator and subject to approval by the local institutional review board.
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Source: ClinicalTrials.gov.
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