Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07130357

The Effect of Collagen Scaffold Augmentation in Achilles Tendon Rupture Repair

Led by Chinese University of Hong Kong · Updated on 2026-03-25

48

Participants Needed

1

Research Sites

105 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

The Effect of Collagen Scaffold Augmentation in Achilles Tendon Rupture Repair

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Achilles tendon rupture
  • Age over 18 years
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Allergy to bovine-derived materials
  • Foot or ankle surgery or treatment within the past year
  • Ongoing legal case related to current injury
  • Active psychological or physical conditions preventing participation, including psychosis, intellectual disability, or stroke

AI-Screening

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Trial Site Locations

Total: 1 location

1

Prince of Wales Hospital

Shatin, New Territories, Hong Kong, 000000

Actively Recruiting

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Research Team

S

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

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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