A Randomized Controlled Trial Evaluating High-Purity Type I Collagen Wrap Around Extensor Tendon Repair Sites in Zones VI-VIII of the Hand to Prevent Adhesions and Improve Functional Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Total Active Motion (TAM) of Involved Finger(s)
研究概览
简要总结
Tendon injuries of the hand, particularly extensor tendons, are prone to postoperative adhesions, extensor lag, and stiffness, leading to functional impairment. This multicentric randomized controlled trial evaluates whether wrapping repaired extensor tendons with a high-purity Type I collagen (HPTC) biologic membrane can reduce adhesion formation and improve functional outcomes compared with standard repair alone.
详细描述
Extensor tendon injuries of the hand are common due to the superficial location of the tendons and the thin soft tissue envelope over the dorsum of the hand and wrist. These injuries, particularly in zones VI-VIII, are frequently associated with postoperative adhesions and extensor lag, leading to functional impairment and delayed return to work. Postsurgical adhesions may occur in up to 30-40% of tendon injuries and remain a major clinical challenge despite advances in suture techniques and rehabilitation protocols.
Several strategies have been investigated to minimize tendon adhesions, including optimized suture techniques, early mobilization, anti-adhesive agents, and biologic barrier membranes. Recent clinical work has shown that wrapping repaired extensor tendons with an amniotic membrane in zone VI can improve range of motion (ROM), Quick DASH scores, and recovery time, suggesting a true reduction in peritendinous fibrosis. Experimental models have also demonstrated that collagen-glycosaminoglycan (GAG) wraps can reduce early postoperative tendon adhesions while preserving tendon healing strength.
HPTC is a bioengineered, acellular dermal replacement product composed of >97% pure Type I collagen, free of elastin, lipids, and immunogenic proteins. It is manufactured to preserve the native triple helical structure and bioactivity of collagen, providing a cell-conducive scaffold that promotes neovascularization, granulation tissue formation, and tissue remodelling. HPTC is flexible, translucent, moderately tacky, and can be cut, sutured or stapled, making it feasible to be fashioned as a wrap or sleeve around tendons.
Multiple randomized controlled trials and clinical series by Narayan et al. have demonstrated the safety and efficacy of high-purity Type I collagen-based skin substitute HPTC in chronic and acute wounds.
These studies collectively show that high-purity Type I collagen membranes are safe, well tolerated, promote faster wound healing, and have favourable scarring and pain profiles in a variety of clinical settings.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years.
- •Acute open laceration of extensor tendons in zone VI, VII, or VIII of the hand / wrist (according to Verdan's classification), involving digits 2-5 and/or wrist extensors.
- •Complete tendon laceration (≥50% tendon cross-sectional area), requiring primary repair.
- •Time from injury to surgical repair ≤72 hours.
- •Single upper limb involved.
- •Ability and willingness to comply with postoperative rehabilitation protocol and follow-up visits.
- •Provision of written informed consent.
排除标准
- •Crush, avulsion, or segmental tendon loss requiring graft or tendon transfer.
- •Associated open fractures requiring dorsal plating across the repair site, or extensive bone loss affecting joint stability.
- •Previous surgery or significant scarring over the injured extensor tendon region.
- •Associated major nerve injury requiring graft or complex reconstruction (digital nerve repair without grafting may be allowed if balanced between groups).
- •Uncontrolled systemic illness (e.g., HbA1c > 8.5% for diabetes, severe peripheral vascular disease, chronic steroid use, severe malnutrition).
- •Active infection at the injury site.
- •Known allergy or hypersensitivity to bovine/ovine collagen or any component of HPTC.
- •Pregnancy or lactation.
- •Inability to provide informed consent or comply with follow-up.
研究组 & 干预措施
HPTC Wrap + Standard Extensor Tendon Repair
After completion of standard extensor tendon repair, a sterile high-purity Type I collagen sheet is hydrated, trimmed, and loosely wrapped circumferentially around the repaired tendon segment to act as a resorbable biologic barrier aimed at reducing peritendinous adhesions.
干预措施: High-Purity Type I Collagen (HPTC) Wrap (Device)
Standard Extensor Tendon Repair Alone
Primary extensor tendon repair using standard core and epitendinous sutures without use of any biologic wrap or anti-adhesion adjunct.
干预措施: Standard Extensor Tendon Repair (Procedure)
HPTC Wrap + Standard Extensor Tendon Repair
After completion of standard extensor tendon repair, a sterile high-purity Type I collagen sheet is hydrated, trimmed, and loosely wrapped circumferentially around the repaired tendon segment to act as a resorbable biologic barrier aimed at reducing peritendinous adhesions.
干预措施: Standard Extensor Tendon Repair (Procedure)
结局指标
主要结局
Total Active Motion (TAM) of Involved Finger(s)
时间窗: 8 weeks postoperatively
Total Active Motion (TAM) is calculated as the sum of active flexion at the metacarpophalangeal (MCP), proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints minus the extension deficits. TAM is expressed in degrees. Higher values indicate better functional outcome.
次要结局
- Number of Participants With Clinically Significant Tendon Adhesions(Up to 8 weeks postoperatively)
- Grip Strength(8 weeks postoperatively)
- QuickDASH Score(6 weeks and 8 weeks postoperatively)
- Extensor Lag(8 weeks postoperatively)
- Adhesion-Related Events(Up to 8 weeks postoperatively)
- Complication Rates(From surgery to 8 weeks postoperatively)
- Time to Return to Work or Activities of Daily Living(Up to 8 weeks postoperatively)
- Patient Satisfaction(8 weeks postoperatively)