Clinical Outcomes of USCTR vs. mOCTR

  • STATUS
    Recruiting
  • End date
    Aug 29, 2023
  • participants needed
    510
  • sponsor
    Walter Reed National Military Medical Center
Updated on 29 May 2021
neuropathy
carpal tunnel release
entrapment neuropathies

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 (CTR) represents the definitive management option, and over 550,000 CTRs are performed annually in the United States with over 90% of patients reporting clinical improvement. Currently available CTR techniques include mini-open CTR via a single, 1-3 cm palmar incision (mOCTR), endoscopic CTR via one (wrist) or two (wrist and palm) 1-2 cm incisions (ECTR), and ultrasound guided CTR via a single < 1 cm wrist or palmar incision (USCTR). The primary objective is to assess the impact of USCTR vs mOCTR in a military population. This study is a multi-site prospective randomized comparative trial.

Participants with CTS will be randomized to a study arm and receive treatment with ultrasound guided carpal tunnel release (USCTR) vs. traditional mini-open carpal tunnel release (mOCTR). All patients will be followed for a period of 24 months with respect to standard clinical data, military relevant data, and validated patient related outcome measures (PROMs). Data will be collected at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, and 12 months, and 24 months post-CTR procedure.

Investigators hypothesize that USCTR using the SX-One MicroKnife will safely and more-effectively improve symptoms of carpal tunnel syndrome compared to traditional mOCTR, with less loss of military duty days.

Details
Condition Carpal Tunnel Syndrome
Treatment USCTR, mOCTR
Clinical Study IdentifierNCT04504019
SponsorWalter Reed National Military Medical Center
Last Modified on29 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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 bifid median nerve or space occupying lesions within the carpal tunnel)
Electrodiagnostic evaluation of the carpal tunnel which indicates normal findings
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