A Multicenter, Evaluator-Blinded, Randomized Evaluation of DYNAVISC in Pain Reduction Following Revision Surgery for Persistent or Recurrent Carpal Tunnel Syndrome
The trial will evaluate the efficacy of DYNAVISC in subjects with a diagnosis of persistent or recurrent carpal tunnel syndrome. This is a prospective, multicenter, randomized, evaluator-blinded clinical trial. Results will be stratified based on the method used for median nerve coverage: Group 1 (standard of care surgery followed by DYNAVISC surrounding the median nerve, n=25 participants), Group 2 (standard of care surgery followed by coverage of the median nerve with a hypothenar fat pad flap, n=25
• Signed and dated informed consent form;
• Stated willingness to comply with all study procedures and availability for the duration of the study;
• Aged 18-65 years of age;
• In good general health;
• Patients experiencing recurrence or persistence of pain in the ipsilateral hand after previous carpal tunnel release for surgical treatment of primary carpal tunnel syndrome;
• All of the following physical examination tests must be performed; at least one must be positive:
‣ Physical examination demonstrates positive Phalen test;
⁃ Physical examination demonstrates positive Tinel's test;
⁃ Physical examination demonstrates positive monofilament test;
• ENMG demonstrates median nerve velocity and deviation consistent with the diagnosis of carpal tunnel syndrome.