NCT07130357 The Effect of Collagen Scaffold Augmentation in Achilles Tendon Rupture Repair
| NCT ID | NCT07130357 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Achilles Tendon Rupture |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2025-12-25 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2025-12-25 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This prospective multicenter randomized controlled trial evaluates the clinical efficacy of collagen scaffold augmentation in surgical repair for acute Achilles tendon ruptures. The study will enroll 48 adult participants randomly assigned to either the intervention group (surgical repair with collagen scaffold augmentation) or the control group (standard surgical repair without scaffold). The primary outcome is tendon function assessed using the VISA-A score, while secondary outcomes include tendon healing characteristics measured by ultrasound (thickness, neovascularity), calf muscle strength, ankle range of motion, and complication rates. Follow-up assessments will be conducted at 6 weeks, 3 months, 6 months, and 12 months post-surgery. The study aims to determine whether collagen scaffold augmentation enhances tendon healing and functional recovery compared to conventional repair methods, potentially offering a improved treatment approach for Achilles tendon injuries.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07130357 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Achilles Tendon Rupture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07130357 currently recruiting?
Yes, NCT07130357 is actively recruiting participants. Contact the research team at samuel.ling@link.cuhk.edu.hk for enrollment information.
Where is the NCT07130357 trial being conducted?
This trial is being conducted at Shatin, Hong Kong.
Who is sponsoring the NCT07130357 clinical trial?
NCT07130357 is sponsored by Chinese University of Hong Kong. The trial plans to enroll 48 participants.