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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
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.
OrthoCarolina Research Institute
Charlotte, North Carolina, United States
Change from Baseline in Static two-point discrimination
Presented in millimetres and in ASSH designation (less than 6 mm 'normal', 6-10 mm 'fair', and 11 to 15 mm 'poor')
Time frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months
Change in Visual Analog Scale (VAS)
Pain Score (1-10, 1 being the best and 10 being the worst pain)
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 3 months, 6 months, 12 months
Water emersion testing
Recommend patients submerge injured hand into water until other digits wrinkle. Report weekly if finger wrinkles like non-injured digits.
Time frame: 2 weeks, 6 weeks, 12 weeks, 3 months, 6 months, 12 months
Physician Satisfaction Score
Scale 0-5, with 0 being very difficult and 5 being very Easy the best score
Time frame: Operative
How many nerves were repaired with the provided graft sheet?
How many nerves were repaired with the provided graft sheet?
Time frame: Operative
Change in Range of Motion (ROM)
Change in Range of Motion (ROM) of the injured digit, measured in degrees, from baseline
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 3 months, 6 months, 12 months
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