Clinical Outcomes of USCTR vs. mOCTR

NCT ID: NCT04504019

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-02
• Study Completion Date: 2025-08-06

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 (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.

Detailed Description

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

Conditions

Carpal Tunnel

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

USCTR Procedure

Participants will undergo the USCTR procedure with SX-One MicroKnife®, also known as UltraGuideCTR

Group Type: EXPERIMENTAL

USCTR

Intervention Type: DEVICE

Ultrasound guided CTR via a single \< 1 cm wrist or palmar incision. The procedure will be performed using the SX-One MicroKnife®, also known as UltraGuideCTR

mOCTR Procedure

Participants will undergo the traditional mOCTR procedure.

Group Type: ACTIVE_COMPARATOR

mOCTR

Intervention Type: PROCEDURE

Mini-open CTR via a single 1-3cm palmar incision

Interventions

USCTR

Ultrasound guided CTR via a single \< 1 cm wrist or palmar incision. The procedure will be performed using the SX-One MicroKnife®, also known as UltraGuideCTR

Intervention Type: DEVICE

mOCTR

Mini-open CTR via a single 1-3cm palmar incision

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Uniformed Services University of the Health Sciences

FED

Sponsor Role: collaborator

Walter Reed National Military Medical Center

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Walter Reed National Military Medical Center

Locations

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

WRNMMC-2020-0278

Identifier Type: -

Identifier Source: org_study_id