Collagen scaffold augmentation to support Achilles tendon repair
Official title: Prospective Multi-Centre Randomised Controlled Trial on the Effect of Collagen Scaffold Augmentation in Achilles Tendon Rupture Repair
Run by Chinese University of Hong Kong · NCT07130357 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 48 (estimated) |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Shatin, New Territories) |
| Status | Recruiting |
| Started | December 25, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | March 25, 2026 |
| Trial ID | NCT07130357 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.