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 participants).

All participants will gently mobilize their wrist and fingers immediately following surgery and multiple times daily thereafter. Strenuous movements will be allowed beginning 6 weeks following surgery. Participant's hand will be evaluated at 1 week, 4 weeks, and 12-weeks following surgery.

Pain measurement will be recorded by participant using visual analog scale (VAS Score); hand function measurement will be recorded by participant using Disabilities of the Arm, Shoulder and Hand (Quick DASH Score); neuropathic pain will be measured by DN4 Score; median nerve recovery will be measured by electroneuromyography (sensory conduction speed and distal motor latency); and grip strength will be measured by dynamometer. This information will be obtained and recorded at baseline and at evaluations by a person blinded to treatment assignment.

Inclusion criteria

• 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.

Exclusion criteria

• Inability to understand the clinical trial and/or sign the Informed Consent;
• Unable or unwilling to attend all of the study prescribed visits and data collection forms;
• Active infection requiring medication;
• Drug requiring diabetes mellitus;
• Collagenopathies;
• Hypothyroidism requiring medication;
• Rheumatoid arthritis requiring medication;
• Autoimmune disease requiring medication;
• Cervical nerve compression;
• Hematopoietic disorders;
• Lacertus fibrosis;
• Psychiatric disorder requiring medical treatment;
• Subject of workers compensation claim;
• History of cancer, except for basal or squamous cell skin cancer;
• Known allergic reactions to components of DYNAVISC;
• Actively participating in another clinical trial.