Investigator-led Observational Clinical Research Project Evaluating the Impact of the ReFeel for Digital Nerve Injuries.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change from Baseline in Static two-point discrimination
研究概览
简要总结
This is an Investigator Led single-center, Prospective and Observational, Clinical Research Project. The specific aim of this study is to test/observe the safety and effectiveness of the ReFeel Device for Digital nerve injury in improving recovery time and outcomes. The primary objective of this study is to monitor clinical and surgical procedural outcomes for the use of ReFeel device.
详细描述
ReFeel is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity, or the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
ReFeel is a device used in applications for patients with peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity, or the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
Despite this common injury there is continued debate on the best treatment algorithm for digital nerve injuries. Digital nerve repair is usually not an option as the field of injury is too large for direct repair. Both conduits and nerve allograft have been used with varying success. Nerve conduits have traditionally been used for gaps less than 2 cm, with allograft for larger gaps.
ReFeel has received 510(k) clearance for a new alginate-based nerve cuff. We propose to conduct an Investigator-led Observational Clinical Research of ReFeel for patients treated with alginate nerve cuff to assess the clinical function following reconstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-69 years
- •Digital nerve injury in at least one digit requiring repair with a gap of 1-25mm
- •Able to provide tension free end to end nerve coaptation
- •Have uninjured contralateral or adjacent digit that is suitable to serve as a referenced digit for baseline functional assessments.
- •Willing to comply with follow up for visits up to 12 months.
排除标准
- •Estimated distance of recovery greater than 150 mm (from proximal site of to the tip of the digit)
- •Injury distal to distal interphalangeal joint
- •Extensive soft tissue injury that will impair recovery assessment
- •Incomplete nerve transections
- •Injury requiring replantation of the target digit
- •Injuries to the affected nerve proximal to the superficial arch
- •Nerve injuries > 24 weeks after initial injury
- •End to side nerve repair
- •Injuries with vascular damage resulting in inadequate perfusion despite repair
- •Subjects with type 1 diabetes or type 2 diabetes requiring regular insulin therapy
- •Subjects who are undergoing or expected to undergo treatment with chemotherapy, radiation therapy, or other know treatment that affects the growth of neural and/or vascular system
- •History of neuropathy, diabetic neuropathy, or another known neuropathy
- •Excepted use of medication during the study that is known to impact nerve regeneration or cause peripheral neuropathy such as immunosuppressant's and Chemotherapeutic
- •History of chronic ischemic condition of the upper extremity.
- •Workers Compensation
研究组 & 干预措施
ReFeel device
Subjects who enroll in this study will receive ReFeel device for Digital nerve injury
干预措施: ReFeel (Device)
结局指标
主要结局
Change from Baseline in Static two-point discrimination
时间窗: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months
Presented in millimetres and in ASSH designation (less than 6 mm 'normal', 6-10 mm 'fair', and 11 to 15 mm 'poor')
次要结局
- Change in Visual Analog Scale (VAS)(Baseline, 2 weeks, 6 weeks, 12 weeks, 3 months, 6 months, 12 months)
- Water emersion testing(2 weeks, 6 weeks, 12 weeks, 3 months, 6 months, 12 months)
- Physician Satisfaction Score(Operative)
- How many nerves were repaired with the provided graft sheet?(Operative)
- Change in Range of Motion (ROM)(Baseline, 2 weeks, 6 weeks, 12 weeks, 3 months, 6 months, 12 months)