A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Peripheral Nerve Repair (NeuroSpan-1)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 14
- 主要终点
- Safety- Complications and adverse events including infections, inflammation, tissue rejections, neuroma formation, chronic pain, and device malfunctions occurring between the treatment procedure and the 12-month follow-up visit.
研究概览
简要总结
This is a multicenter, prospective, randomized, subject and evaluator blinded clinical trial to asses the efficacy of Auxilium's NeuroSpan Bridge.
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)
盲法说明
Blinding will occur to the subject and the blinded assessor. The blinded assessor will remain blinded from the device that was implanted. For subjects, blinding will be accomplished by informing subjects during the consent process that they may or may not also receive a secondary procedure in which they could have an incision in their leg that is not dependent on the device in which they are randomized to receive. Blinding will be assessed by the use of blinding assessment to both the assessor at the patient at the 12 month follow-up visit.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 80 with upper or lower extremity nerve injury with a gap of 0.5 to 3.0 cm.
- •Nerve diameter at injury site ≤3mm.
- •Nerve injury location is the arm from the shoulder to the wrist, including the hand or the leg from the hip to the ankle including the foot.
- •For Motor Nerve Injuries: Distance from site of injury to the nearest innervated muscle: ≤100mm
- •For Sensory and Mixed Nerve injuries: Distance from the site of injury to the nearest sensory nerve target: ≤250mm
- •Repair must take place within 3 months from injury
- •No contraindications to surgical repair (e.g., risk of concurrent infection, dog bite)
排除标准
- •Previous history of nerve repair attempt at the treated nerve.
- •Concurrent disease that reduces nerve regeneration: diabetes, previous diagnosis of non-traumatic peripheral neuropathy, chemotherapy treatment, other causes of peripheral neuropathy.
- •Allergy to Bovine products such as Bovine Collagen Nerve Cuff.
- •Pregnancy or planning to become pregnant
研究组 & 干预措施
NeuroGen Nerve Guide
The control arm will comprise of subjects requiring injury repair of 0.5-1.0cm. These subjects will receive the NeuraGen Nerve Guide.
干预措施: NeuroSpan Bridge (Device)
NeuroGen Nerve Guide
The control arm will comprise of subjects requiring injury repair of 0.5-1.0cm. These subjects will receive the NeuraGen Nerve Guide.
干预措施: NeuroGen Nerve Guide (Device)
Nerve Autograft
The control arm will comprise of subjects requiring injury repair of 1.1-3.0cm. These subjects will receive the Nerve Autograft.
干预措施: NeuroSpan Bridge (Device)
Nerve Autograft
The control arm will comprise of subjects requiring injury repair of 1.1-3.0cm. These subjects will receive the Nerve Autograft.
干预措施: Nerve Autograft (Device)
结局指标
主要结局
Safety- Complications and adverse events including infections, inflammation, tissue rejections, neuroma formation, chronic pain, and device malfunctions occurring between the treatment procedure and the 12-month follow-up visit.
时间窗: 12 months
This endpoint will examine complications and adverse events including infections, inflammation, tissue rejections, neuroma formation, chronic pain, and device malfunctions occurring between the treatment procedure and the 12-month follow-up visit.
Efficacy- Static two-point discrimination (s2PD) measured at 12 months.
时间窗: 12 months
This endpoint will examine the change in Static two-point discrimination (s2PD) measured at 12 months.
次要结局
- The summary score from the Disabilities of the Arm Shoulder and Hand (DASH) questionnaire at 12 months.(12 months)
- The summary score from the Disabilities of the Arm Shoulder and Hand (DASH) Sports/Performing Arts Module at 12 months.(12 months)
- Moving 2 Point Discrimination test (m2PD) in the target digit at 12 months.(12 months)
- The summary score from the Disabilities of the Arm Shoulder and Hand (DASH) Work Module at 12 months.(12 months)
- Motor function assessed by the British Medical Research Council grading system (categories 0, 1, 2, 3, 4, 5) at 12 months.(12 months)
- Sensory function assessed by the British Medical Research Council grading system at 12 months.(12 months)