NCT00948025终止不适用
A Multicenter, Prospective, Randomized, Comparative Study of Hollow Nerve Conduit and Avance Nerve Graft Evaluating Recovery Outcomes of Nerve Repair in the Hand. (CHANGE)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 8
- 主要终点
- Recovery of Static 2-point Discrimination in the Affected Digit
研究概览
简要总结
This study is a comparison of sensory recovery outcomes following the use of AVANCE Nerve Graft or hollow tube conduit for peripheral nerve gap repairs in the hand.
详细描述
The CHANGE study is a post-marketing study designed as a prospective, single-blind, randomized, two phase study comparing clinical outcomes of AVANCE Nerve Graft to hollow tube conduits. The first phase (pilot phase) assesses projected differences expected between two treatment groups. The second phase of the study provides comparison data between the two treatment groups.
AVANCE Nerve Graft is current regulated in the United States as a 361 HCT/P Tissue for transplantation; not a Drug, Biologic, or Medical Device. Hollow tube conduits are currently regulated in the United States as medical devices.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Require primary or secondary nerve injury repair with Hollow Nerve Conduit or AVANCE™ in at least 1 digital nerve;
- •Undergo End to End nerve to nerve graft coaptation on both the proximal and distal portion of the nerve gap in the AVANCE™ group or nerve entubulation in the Hollow Nerve Conduit group;
- •Be willing to comply with all aspects of the treatment and evaluation schedule over a 12 Month duration; and
- •Sign and date an IRB-approved written informed consent prior to initiation of any study procedures, including screening procedures.
排除标准
- •Nerve gaps of < 5 mm or > 20 mm;
- •Estimated distance of regeneration of >125 mm (distance from injury site to sensory target)
- •Nerve crush or avulsion injuries;
- •Incomplete nerve transections;
- •Injury requiring replantation of target digit;
- •Contralateral digital injuries corresponding to the target digit;
- •Nerve injuries in the affected limb proximal to the crease of the wrist;
- •End to side nerve repair;
- •Injuries with significant vascular damage which may impair adequate perfusion of the target limb;
- •Subjects who are undergoing treatment with chemotherapy, radiation therapy, or other know treatment which affects the growth of neural and/or vascular system;
- •Use of bovine collagen based hollow nerve conduit in a subject with known or suspected bovine sensitivity;
- •Subjects age ≤18 years or ≥70 years;
- •History neuropathy, diabetic or any other known neuropathy;
- •Secondary nerve repair >12 weeks post initial injury;
- •Currently enrolled in another investigational study;
- •Expected use of medications during the study that are known to cause peripheral neuropathy;
- •History or Reynaud's or other disorder known to compromise circulation or sensation in the upper extremity; and
- •Any subject who at the discretion of the Investigator is not suitable for inclusion in the study.
结局指标
主要结局
Recovery of Static 2-point Discrimination in the Affected Digit
时间窗: 12 Months
Mean change in static 2-Point Discrimination between baseline and 12 months
次要结局
- Pain at 12-months(12-months)
- Moving 2-point Discrimination(12 months)
- Semmes-Weinstein Monofilament Assessment(12 months)
- 12-month DASH Core Module Scores(12 months)
- 12-month DASH (Work Module) Scores(12 month)
- Thermal Discretion at 12-months(12-month)
- 12- Month DASH (Sports/Performing Arts Module)(12 months)
- Protective Sensation Present at 12-months(12 months)
- Functional Recovery Classification (Medical Research Council Evaluation of Sensory Function) at 12-months(12 months)
研究者
研究点 (8)
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