Dynavisc to reduce pain after revision carpal tunnel surgery

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

This study will test whether applying Dynavisc around the median nerve reduces pain in adults who have persistent or recurrent carpal tunnel symptoms after prior surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: FzioMed (industry)
• Locations: 4 sites (Leuven, Belgium and 3 other locations)
• Trial ID: NCT06593977 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, randomized, evaluator-blinded trial enrolling adults with recurrent or persistent carpal tunnel syndrome after prior release. Participants undergo standard-of-care revision surgery and are randomized to have the median nerve covered with Dynavisc or with a hypothenar fat pad flap, with 25 participants planned per group. Outcomes include patient-reported pain (VAS), hand function (QuickDASH), neuropathic pain (DN4), nerve conduction studies, and grip strength measured at baseline and at 1, 4, and 12 weeks postoperatively. Patients will begin gentle finger and wrist mobilization immediately and resume strenuous activity at six weeks, and assessments are performed by personnel blinded to treatment assignment.

Who should consider this trial

Good fit: Adults 18–65 in generally good health who have recurrent or persistent symptoms in the same hand after prior carpal tunnel release, with at least one positive clinical test (Phalen, Tinel, or monofilament) and ENMG findings consistent with CTS are ideal candidates.

Not a fit: Patients outside the 18–65 age range, those with other causes of hand pain or severe systemic disease, or those unable to attend follow-up visits are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, Dynavisc could lower postoperative pain and improve nerve recovery and hand function after revision carpal tunnel surgery.

How similar studies have performed: Anti-adhesion and nerve coverage approaches have shown promise in smaller series, but randomized evidence specifically supporting Dynavisc for revision carpal tunnel is limited.

Eligibility criteria

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.

Where this trial is running

Leuven, Belgium and 3 other locations

• UZ Leuven — Leuven, Belgium, Belgium (RECRUITING)
• AZ Delta — Roeselare, Belgium, Belgium (RECRUITING)
• Hospital Angelina Caron — Araçatuba, Brazil, Brazil (RECRUITING)
• Azienda Ospedale Universita Padova — Padova, Italy, Italy (RECRUITING)

Study contacts

• Study coordinator: Gere diZerega, MD

Conditions: Carpal Tunnel Syndrome, carpal tunnel, revision