Prospective Multi-Centre Randomised Controlled Trial on the Effect of Collagen Scaffold Augmentation in Achilles Tendon Rupture Repair
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 主要终点
- Victorian Institute of Sports Assessment (VISA-A)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Achilles tendon rupture.
- •Age > 18 and able to provide written informed consent.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Collagen Scaffold (Device)
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
干预措施: Achilles tendon repair (Procedure)
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.
干预措施: Achilles tendon repair (Procedure)
结局指标
主要结局
Victorian Institute of Sports Assessment (VISA-A)
时间窗: 6 weeks and 3, 6, 12 months after surgery
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.
次要结局
- 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)
- Achilles tendon resting angle(6 weeks and 3, 6, 12 months)
- Calf muscle strength(6 weeks and 3, 6, 12 months)
- Ankle range of motion(6 weeks; 3, 6, 12 months)
- Jump test(6 weeks; 3, 6, 12 months)
- Tendon oxygenation and vascularity(6 weeks; 3, 6, 12 months)
- Thermographic tendon temperature(6 weeks; 3, 6, 12 months)
- Achilles Tendon Total Rupture Score(6 weeks; 3, 6, 12 months)
研究者
Samuel KK Ling
Dr.
Chinese University of Hong Kong