RecruitingNot ApplicableNCT06593977

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

A Multicenter, Evaluator-Blinded, Randomized Evaluation of DYNAVISC in Pain Reduction Following Revision Surgery for Persistent or Recurrent Carpal Tunnel Syndrome

Sponsor

FzioMed

Enrollment

50 participants

Start Date

Mar 26, 2026

Study Type

INTERVENTIONAL

Conditions

Carpal Tunnel Syndrome (CTS)

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria10

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 Criteria16

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.