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The Effect of Collagen Scaffold Augmentation in Achilles Tendon Rupture Repair
Sponsor: Chinese University of Hong Kong
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.
Official title: Prospective Multi-Centre Randomised Controlled Trial on the Effect of Collagen Scaffold Augmentation in Achilles Tendon Rupture Repair
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2025-12-25
Completion Date
2027-12-31
Last Updated
2026-03-25
Healthy Volunteers
No
Conditions
Interventions
Collagen Scaffold
The bioinductive collagen scaffold will be placed over the repair site and secured with soft tissue anchors.
Achilles tendon repair
Upon diagnosis of an Achilles tendon rupture, the participant will receive a temporary slab and surgical repair will be scheduled, and the operation will be performed under general anaesthesia with the patient lying prone. The ruptured ends of the right Achilles tendon will be marked, and a 3 cm longitudinal skin incision will be made along the medial border of the tendon. A standardized end-to-end direct surgical repair using non-absorbable sutures in a 2-strand core in a krackow locking fashion will be performed. The surgical site will be closed in layers using 3-0 vicryl and 4-0 ethilon.
Locations (1)
Prince of Wales Hospital
Shatin, New Territories, Hong Kong