Clinical Outcomes of USCTR vs. mOCTR

Walter Reed National Military Medical Center

Status

Completed

Conditions

Carpal Tunnel

Treatments

Procedure: mOCTR

Device: USCTR

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT04504019

WRNMMC-2020-0278

Details and patient eligibility

About

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 or CTR-US). The primary objective is to assess the impact of USCTR vs mOCTR in a military population. Investigators hypothesize that USCTR using the SX-One MicroKnife, also known as UltraGuideCTR, will safely and non-inferiorly improve symptoms of carpal tunnel syndrome compared to traditional mOCTR, without greater less loss of military duty days. This study is a single-site randomized controlled trial.

Participants with CTS will be randomized to a study arm and receive treatment with USCTR vs. traditional 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, with the primary focus being on outcomes up to 1 year.

Full description

Clinical outcomes of up to 83 participants (updated target sample size) treated with USCTR vs. traditional mOCTR will be investigated.

Enrollment

41 patients

Sex

All

Ages

18 to 89 years old

Volunteers

Accepts Healthy Volunteers

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 transligamentous thenar motor branch or space occupying lesions within the carpal tunnel)
Electrodiagnostic evaluation of the carpal tunnel which indicates normal findings