The Effect of Collagen Scaffold Augmentation in Achilles Tendon Rupture Repair

NCT ID: NCT07130357

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2027-12-31

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.

Detailed Description

This study is a prospective multi-center randomized controlled trial investigating the effects of collagen scaffold augmentation in surgical repair of acute Achilles tendon ruptures. The research builds upon existing clinical experience and literature suggesting that while surgical techniques have improved mechanical stability of repaired tendons, biological healing remains a limiting factor in recovery. The trial will compare two treatment approaches: one group will receive standard surgical repair augmented with a collagen scaffold, while the control group will undergo conventional repair without scaffold augmentation.

A total of 48 participants will be recruited from five hospitals and randomly assigned to either group with a 1:1 allocation ratio. The surgical procedure involves end-to-end tendon repair using non-absorbable sutures, with the intervention group additionally receiving a bioinductive collagen scaffold placed over the repair site. All participants will follow the same standardized rehabilitation protocol divided into four phases: protection, early loading, strengthening, and return to function.

Intervention Group:

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 protection phase, early loading phase, strengthening phase and return to function phase. This plan includes non-weight-bearing walking for 2 weeks, partial weight-bearing walking for 4 weeks, then full weight-bearing walking.

Control Group:

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.

The primary outcome measure is the Victorian Institute of Sports Assessment-Achilles (VISA-A) score, which evaluates pain, function, and sporting activity. Secondary outcomes include surgical complications, Foot and Ankle Outcome Score (FAOS), ultrasound measurements of tendon thickness and neovascularity, shear wave elastography for tendon elasticity, Achilles tendon resting angle, calf muscle strength, ankle range of motion, and photoacoustic imaging of tendon oxygen saturation. Participants will be assessed at baseline, 6 weeks, 3 months, 6 months, and 12 months post-surgery.

Conditions

Achilles Tendon Rupture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

Collagen Scaffold

Intervention Type: DEVICE

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

Achilles tendon repair

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Achilles tendon repair

Intervention Type: 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.

Interventions

Collagen Scaffold

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

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Samuel KK Ling

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

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

Role: CONTACT

samuel.ling@link.cuhk.edu.hk

+852 3505-2010

Other Identifiers

2025.416

Identifier Type: -

Identifier Source: org_study_id