The Effect of Collagen Scaffold Augmentation in Achilles Tendon Rupture Repair
ConditionAchilles Tendon Rupture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong
About this trial
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
This trial does not accept healthy volunteersQualifiers
Achilles tendon rupture.
Age > 18 and able to provide written informed consent.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Collagen Scaffold
DeviceThe bioinductive collagen scaffold will be placed over the repair site and secured with soft tissue anchors.
Achilles tendon repair
Procedure/SurgeryUpon 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.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 2 interventions
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
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.
Time frame
6 weeks and 3, 6, 12 months after surgerySecondary outcomes
1
Surgical complications
Surgical complications will be recorded, such as would problems and early re-ruptures. Based on current evidence, approximately 1 in 9 patients undergoing operative repair of an acute Achilles tendon rupture developed a postoperative complication.
Time frame
During surgery2
Foot and Ankle outcome scores (FAOS)
The Foot and Ankle Outcome Score (FAOS) is a open-source, validated piece of instrument to evaluate overall foot and ankle function . It is extensively used in foot and ankle clinical research and is calculated using multiple Likert scale questions which are organized into 5 sub-categories: symptoms, pain, activities of daily living (ADL), sports and quality of life (QOL). The answers in each subcategory are then converted into a score from 0 to 100; with 100 resembling no symptoms and 0 resembling severe symptoms.
Time frame
6 weeks and 3, 6, 12 months3
Ultrasound measure of tendon thickness
B-mode ultrasound will be used to locate and measure the maximum thickness of the Achilles tendon (4-9mm) using a greyscale sonographic image. To minimize anisotropic effect, the transducer will be adjusted to ensure the ultrasound beam is perpendicular to the tendon fibers.
Time frame
6 weeks and 3, 6. 12 months4
Ultrasound measurement of tendon neovascularity
Doppler mode is used to measure tendon neovascularity. The transducer is placed perpendicular to obtain a sagittal view of the Achilles tendon. The assessor screens the tendon for the area of maximum Doppler flow and takes a sonographic image. The Öhberg score is then determined during the US examination. Scores range from 0 to 3, with a higher score indicating more Doppler flow in the peritendinous and intratendinous tissues. Pressure from the transducer will be kept to a minimum to prevent occlusion of neovascularization
Time frame
6 weeks and 3, 6 ,12 monthsSponsors and contacts
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Source ClinicalTrials.gov