Dynavisc: DYNAVISC (1 ml) will be applied over/around the median nerve, including repair site, by the surgeon using the applicator provided with the product.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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:
1. Physical examination demonstrates positive Phalen test;
2. Physical examination demonstrates positive Tinel's test;
3. 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.
Primary outcome measure(s)
Pain using VAS — 12 weeks 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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