Mochida ReFeel for Digital Nerve Injuries
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ReFeel.
- Who it may be relevant to
- Registry conditions: Digital Nerve Injury, Nerve Reconstruction. Basic parameters: 18 years — 69 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Investigator-led Observational Clinical Research Project Evaluating the Impact of the ReFeel for Digital Nerve Injuries.
Overview
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.
Detailed description
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.
Interventions
- Device ReFeel
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 tis
Primary outcome measures
- Change from Baseline in Static two-point discrimination [Time frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months]
Secondary outcome measures (5)
- Change in Visual Analog Scale (VAS) [Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 3 months, 6 months, 12 months]
- Water emersion testing [Time frame: 2 weeks, 6 weeks, 12 weeks, 3 months, 6 months, 12 months]
- Physician Satisfaction Score [Time frame: Operative]
- How many nerves were repaired with the provided graft sheet? [Time frame: Operative]
- Change in Range of Motion (ROM) [Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 3 months, 6 months, 12 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- OrthoCarolina Research Institute — Charlotte
Identifiers
NCT: NCT07524465 · 9220 (ReFeel - 0001)