Investigator-led Observational Clinical Research Project Evaluating the Impact of the ReFeel for Digital Nerve Injuries.
OrthoCarolina Research Institute, Inc.
Summary
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.
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 digit…
Eligibility
- Age range
- 18–69 years
- Sex
- All
- Healthy volunteers
- No
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 rec…
Interventions
- DeviceReFeel
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.
Location
- OrthoCarolina Research InstituteCharlotte, North Carolina