Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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

Who May Be Eligible (Plain English)

Inclusion criteria - Signed and dated willing to sign a consent form 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 willing to sign a consent form; - 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 conditions (where your immune system attacks your own body) 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DEVICE

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.

Locations (4)

UZ Leuven
Leuven, Belgium, Belgium
AZ Delta
Roeselare, Belgium, Belgium
Hospital Angelina Caron
Araçatuba, Brazil, Brazil
Azienda Ospedale Universita Padova
Padova, Italy, Italy