Collagen scaffold augmentation to support Achilles tendon repair
Prospective Multi-Centre Randomised Controlled Trial on the Effect of Collagen Scaffold Augmentation in Achilles Tendon Rupture Repair
This trial will test whether adding a collagen scaffold during surgical repair helps adults with acute Achilles tendon ruptures recover better than standard repair.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Shatin, New Territories) |
| Trial ID | NCT07130357 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter, randomized controlled trial enrolling 48 adults with acute Achilles tendon rupture who will be assigned 1:1 to standard surgical repair or repair augmented with a bioinductive collagen scaffold. The primary outcome is tendon function measured by the VISA-A score, with secondary outcomes including ultrasound measures of tendon healing (thickness, neovascularity), calf muscle strength, ankle range of motion, and complication rates. All participants receive the same standardized four-phase rehabilitation program and are assessed at 6 weeks, 3 months, 6 months, and 12 months post-surgery. The surgical technique uses end-to-end repair with non-absorbable sutures, and the intervention group additionally receives a collagen scaffold placed over the repair site.
Who should consider this trial
Good fit: Adults (age >18) with an acute Achilles tendon rupture who can provide informed consent, are not allergic to bovine-derived materials, and can attend the required surgery and follow-up visits.
Not a fit: Patients with hypersensitivity to bovine materials, recent foot or ankle surgery within one year, ongoing litigation over the injury, or active psychiatric/neurological conditions are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, adding a collagen scaffold could improve tendon healing and functional recovery, potentially reducing long-term weakness and re-rupture risk.
How similar studies have performed: Collagen scaffold augmentation has shown promising results in tendon augmentation in other contexts (for example rotator cuff), but randomized evidence specifically for acute Achilles tendon repair is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Achilles tendon rupture. 2. Age \> 18 and able to provide written informed consent. Exclusion Criteria: 1. Hypersensitive to bovine-derived materials. 2. Prior foot/ankle surgery or intervention within 1 year 3. Ongoing litigation regarding current injury 4. Active psychological or physical condition pre-empting participation, including psychosis, mental retardation, stroke.
Where this trial is running
Shatin, New Territories
- Prince of Wales Hospital — Shatin, New Territories, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Samuel K Ling, MBChB (CUHK), ChM (Edin), MRCS
- Email: samuel.ling@link.cuhk.edu.hk
- Phone: +852 3505-2010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.