Health TrialsbyHealthPanel

Mochida ReFeel for Digital Nerve Injuries

ConditionsDigital Nerve InjuryNerve Reconstruction
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-69
SponsorOrthoCarolina Research Institute, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

5 Participants
are divided into 1 treatment group
Group A: ReFeel deviceOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

Physician Satisfaction Score

Scale 0-5, with 0 being very difficult and 5 being very Easy the best score

Time frame
Operative
4

How many nerves were repaired with the provided graft sheet?

How many nerves were repaired with the provided graft sheet?

Time frame
Operative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

OrthoCarolina Research Institute, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: