About this trial
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
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Dynavisc