Status:
COMPLETED
Clinical Outcomes of USCTR vs. mOCTR
Lead Sponsor:
Walter Reed National Military Medical Center
Collaborating Sponsors:
Uniformed Services University of the Health Sciences
Conditions:
Carpal Tunnel
Eligibility:
All Genders
18-89 years
Phase:
NA
Brief Summary
Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy and affects 3-6% of adults in the United States. In patients with severe or refractory symptoms, carpal tunnel release ...
Detailed Description
Clinical outcomes of up to 83 participants (updated target sample size) treated with USCTR vs. traditional mOCTR will be investigated.
Eligibility Criteria
Inclusion
- Adults age ≥18 years
- DEERS Eligible
- Fluent in speaking, reading, and understanding English
- Clinical diagnosis of Carpal Tunnel Syndrome (CTS)
- Candidate for surgical CTR based on severe and/or refractory symptoms
- Confirmatory electrodiagnostic test indicating median neuropathy at the wrist (abnormal findings)
- Ultrasound findings consistent with median nerve enlargement in the carpal tunnel
Exclusion
- Previous carpal tunnel release or previous wrist surgery on the ipsilateral side
- Carpal tunnel injection with corticosteroid within 6 weeks prior to anticipated study procedure
- Previous traumatic injury to the median nerve or any of its branches on the ipsilateral side
- History of medical condition that would preclude safe participation in study procedures (e. g. complex regional pain syndrome (CRPS), upper limb vascular disease (including thoracic outlet syndrome), Raynaud's phenomenon, etc.)
- Inability to stop anticoagulation medications (Plavix, Coumadin/Warfarin, Xarelto), or unable to be bridged with Lovenox
- Unable to understand and provide written informed consent
- Contraindication to proceeding with USCTR based on diagnostic ultrasound (i.e. identification of anomalous anatomic structures such as transligamentous thenar motor branch or space occupying lesions within the carpal tunnel)
- Electrodiagnostic evaluation of the carpal tunnel which indicates normal findings
Key Trial Info
Start Date :
March 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 6 2025
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04504019
Start Date
March 2 2021
End Date
August 6 2025
Last Update
September 26 2025
Active Locations (1)
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1
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20814