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;
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;
Parallel
Dynavisc
DeviceDYNAVISC (1 ml) will be applied over/around the median nerve, including repair site, by the surgeon using the applicator provided with the product.
Pain using VAS
Change in pain and paresthesia will be determined by recording VAS Scores at baseline and each Visit following surgery up to 12 weeks following surgery. VAS Score is a 1-10 range, with 1 being the best result.
Resumption of hand function using the Quick DASH Score.
Resumption of hand function following repair of persistent or recurrent carpal tunnel syndrome will be measured by participant using the Quick DASH Score.
Grip strength of hand closing
Grip strength of hand closing is measured by participant using a Jamar Hand Dynamometer as recorded in kilogram-force (kgf).
Improvement in nerve conduction and lateral deviation
Change in velocity of nerve conduction and lateral deviation will be measured by Electroneuromyography (ENMG).
Evaluation of neuropathic pain using DN4 assessment
Change in neuropathic pain of the hand and fingers following repair of persistent or recurrent carpel tunnel syndrome will be performed by participant's scoring of DN4.
