Actively Recruiting
Effect of Collagen Scaffold Augmentation in Achilles Tendon Rupture Repair A Prospective Multi-Centre Randomised Controlled Trial
Led by Chinese University of Hong Kong · Updated on 2026-03-25
48
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
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.
CONDITIONS
Brief Title
The Effect of Collagen Scaffold Augmentation in Achilles Tendon Rupture Repair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Achilles tendon rupture
- Age over 18 years
- Able to provide written informed consent
You will not qualify if you...
- Allergic to bovine-derived materials
- Foot or ankle surgery or treatment within the past year
- Currently involved in legal disputes related to the injury
- Active psychological or physical conditions such as psychosis, mental retardation, or stroke that prevent participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo surgical repair of the Achilles tendon rupture. Those in the intervention group receive additional collagen scaffold augmentation during surgery. Participants are discharged the following day and begin a standardized rehabilitation plan.
1 surgical visit and hospital stay
Duration - 12 months
Participants follow a rehabilitation protocol divided into four phases: protection, early loading, strengthening, and return to function with progressive weight-bearing. Assessments of recovery and tendon healing are conducted.
Visits at 6 weeks, 3 months, 6 months, and 12 months post-surgery
Trial Site Locations
Total: 1 location
1
Prince of Wales Hospital
Shatin, New Territories, Hong Kong, 000000
Actively Recruiting
Research Team
S
Samuel K Ling, MBChB (CUHK), ChM (Edin), MRCS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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