Evaluation of Dynavisc Device Use in Reducing Pain After Revision Surgery for Persistent or Recurrent Carpal Tunnel Syndrome

What this Trial Is About

Researchers are evaluating the effectiveness of DYNAVISC in adults diagnosed with persistent or recurrent carpal tunnel syndrome after previous surgery. This prospective, multicenter, randomized, and evaluator-blinded clinical trial compares two methods for protecting the median nerve during revision surgery standard surgery followed by DYNAVISC application and standard surgery followed by coverage with a hypothenar fat pad flap. Participants will receive revision surgery, after which half will have DYNAVISC 1 ml applied around the median nerve by the surgeon, while the other half will have the nerve covered with a hypothenar fat pad flap. Following surgery, participants will begin gentle wrist and finger movements immediately and gradually increase activity to more strenuous movements starting six weeks after surgery. Follow-up visits for hand evaluations are scheduled at 1 week, 4 weeks, and 12 weeks post-surgery. Throughout the study, participants will report pain levels using a visual analog scale VAS, hand function using the Quick DASH Score, neuropathic pain using the DN4 assessment, and undergo nerve conduction tests with electroneuromyography. Grip strength will be measured with a dynamometer. All assessments will occur at baseline and follow-up visits with evaluators unaware of the treatment group. The main outcome is pain reduction at 12 weeks post-surgery, with additional measures of hand function, nerve recovery, and strength also monitored.

Evaluation of Dynavisc in Pain Reduction Following Revision Surgery for Persistent or Recurrent Carpal Tunnel Syndrome