The Effect of Collagen Scaffold Augmentation in Achilles Tendon Rupture Repair

NCT07130357 | Recruiting DMC

• 1 other identifier: 2025.416
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Achilles Tendon Rupture

Keywords

Achilles Tendon Rupture; Collagen Scaffold Augmentation; Regeneten; Achilles Tendon Rupture Repair

Outcome Measures

Primary Outcomes (1)

• Victorian Institute of Sports Assessment (VISA-A)

  The primary outcome is the score of the Victorian Institute of Sports Assessment - Achilles (VISA-A) questionnaire, which is explicitly designed for Achilles tendon. VISA-A will be used to evaluate pain and symptom severity with activity in participants with Achilles tendon rupture. Chinese-speaking participants will complete the validated Chinese VISA-A questionnaire . The VISA-A questionnaire covers three domains associated with AT: pain, function, and sporting activities. A deterioration in self-reported pain, function and sporting activities is the critical reason patients with Achilles tendon rupture come for medical consultation. Improving questions covered in VISA-A is often the rehabilitation goal for these patients.

  6 weeks and 3, 6, 12 months after surgery

Secondary Outcomes (12)

• Surgical complications

  During surgery

• Foot and Ankle outcome scores (FAOS)

  6 weeks and 3, 6, 12 months

• Ultrasound measure of tendon thickness

  6 weeks and 3, 6. 12 months

• Ultrasound measurement of tendon neovascularity

  6 weeks and 3, 6 ,12 months

• Ultrasound measurement of tendon elasticity

  6 weeks and 3, 6, 12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants in the intervention group will undergo Achilles tendon repair with Collagen Scaffold Augmentation. 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 bioinductive collagen scaffold will be placed over the repair site and secured with soft tissue anchors. The surgical site will be closed in layers using 3-0 vicryl and 4-0 ethilon. The patient will be discharged the following day and will follow a standardized rehabilitation plan by our physiotherapist. The rehabilitation is split into 4 phases: the protect

Device: Collagen Scaffold; Procedure: Achilles tendon repair

Control Group

ACTIVE COMPARATOR

Participants in the control group will undergo Achilles tendon repair using the same method as the intervention group, only without the additional collagen scaffold augmentation. The rehabilitation protocol will also be identical to the intervention group.

Procedure: Achilles tendon repair

Interventions

Collagen Scaffold DEVICE

The bioinductive collagen scaffold will be placed over the repair site and secured with soft tissue anchors.

Intervention group

Achilles tendon repair PROCEDURE

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.

Control Group; Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Achilles tendon rupture.
• Age \> 18 and able to provide written informed consent.

You may not qualify if:

• Hypersensitive to bovine-derived materials.
• Prior foot/ankle surgery or intervention within 1 year
• Ongoing litigation regarding current injury
• Active psychological or physical condition pre-empting participation, including psychosis, mental retardation, stroke.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, New Territories, 000000, Hong Kong

RECRUITING

Central Study Contacts

Samuel K Ling, MBChB (CUHK), ChM (Edin), MRCS

CONTACT

+852 3505-2010; samuel.ling@link.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 19, 2025
• Study Start: December 25, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

HK (1)