Dynavisc to reduce pain after revision carpal tunnel surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: gdizerega@fziomed.com
• Phone: 805-630-2800

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ultrasound-Guided Injection for Carpal Tunnel Syndrome: Hyaluronic Acid vs Corticosteroid vs 5% Glucose

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  Recruiting Early Phase 1 Tanta University · Tanta, Gharbia Governorate · NCT07825155

• Open vs ultrasound-guided carpal tunnel release ( CTS )

  This study compares two surgical approaches for carpal tunnel syndrome to see which helps people recover better after surgery.

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• Amniotic Membrane and Secretome Added to Carpal Tunnel Release

  This trial tests whether adding amniotic membrane and secretome to carpal tunnel surgery helps people with moderate-to-severe CTS recover better than surgery alone.

  Recruiting Early Phase 1 PT. Prodia Stem Cell Indonesia · Denpasar, Bali · NCT07723313

• Reliability and validity of hand function tests in carpal tunnel syndrome

  This study tests whether three hand function tests (JTHFT, MDT, and Nine-Hole Peg Test) are reliable and valid for people with carpal tunnel syndrome.

  Recruiting Izmir Bakircay University · Izmir · NCT07706296

• Neuromobilization, Tendon Gliding, or Both for Mild to Moderate Carpal Tunnel Syndrome

  This trial tests whether neuromobilization, tendon gliding exercises, or a combination of both help reduce pain and improve hand function in people with mild to moderate carpal tunnel syndrome.

  Recruiting Ibadat International University, Islamabad · Islamabad, ICT · NCT07653789

• MeDe: Carpal tunnel release with added lacertus release vs carpal tunnel release alone

  In adults with carpal tunnel syndrome, this trial tests whether adding a lacertus fibrosus release to the standard carpal tunnel release helps reduce symptoms and improve hand function.

  Recruiting at 2 sites Maasstad Hospital · Rotterdam, South Holland and 1 other locations · NCT07594821

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.