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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFzioMed

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

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators