Carpal Tunnel Syndrome (CTS)
Conditions
Keywords
carpal tunnel, revision
Brief 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
Detailed 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.
Interventions
DEVICEDynavisc
DYNAVISC (1 ml) will be applied over/around the median nerve, including repair site, by the surgeon using the applicator provided with the product.
Sponsors
FzioMed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of neuropathic pain using DN4 assessment | 12 weeks | Change in neuropathic pain of the hand and fingers following repair of persistent or recurrent carpel tunnel syndrome will be performed by participant's scoring of DN4. |
| Resumption of hand function using the Quick DASH Score. | 12 weeks | Resumption of hand function following repair of persistent or recurrent carpal tunnel syndrome will be measured by participant using the Quick DASH Score. |
| Grip strength of hand closing | 12 weeks | Grip strength of hand closing is measured by participant using a Jamar Hand Dynamometer as recorded in kilogram-force (kgf). |
| Improvement in nerve conduction and lateral deviation | 12 weeks | Change in velocity of nerve conduction and lateral deviation will be measured by Electroneuromyography (ENMG). |
Countries
Belgium, Brazil, Italy
Contacts
CONTACTGere diZerega, MD
CONTACTStephanie Cortese, MS
STUDY_DIRECTORGere M diZerega, MD
Fziomed Inc.
Outcome results
None listed