Overview
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
Description
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.
Eligibility
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.
