Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
This trial is for adults over 18 with severe or persistent Carpal Tunnel Syndrome (CTS), confirmed by tests showing nerve issues at the wrist. They must speak English and be eligible for military healthcare. People can't join if they've had previous CTS surgery, can't stop blood thinners, have had certain injuries or conditions affecting the arm, or received a recent steroid injection in the carpal tunnel.Inclusion Criteria
Adults age ≥18 years
DEERS Eligible
Fluent in speaking, reading, and understanding English
+4 more
Exclusion Criteria
Unable to understand and provide written informed consent
Previous carpal tunnel release or previous wrist surgery on the ipsilateral side
Inability to stop anticoagulation medications (Plavix, Coumadin/Warfarin, Xarelto), or unable to be bridged with Lovenox
+5 more
Participant Groups
The study compares two surgical techniques for CTS: ultrasound-guided carpal tunnel release (USCTR) using SX-One MicroKnife® versus traditional mini-open release (mOCTR). Participants will be randomly assigned to one of these treatments and followed up for two years to measure recovery and effectiveness.
2Treatment groups
Experimental Treatment
Active Control
Group I: USCTR ProcedureExperimental Treatment1 Intervention
Participants will undergo the USCTR procedure with SX-One MicroKnife®, also known as UltraGuideCTR
Group II: mOCTR ProcedureActive Control1 Intervention
Participants will undergo the traditional mOCTR procedure.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Walter Reed National Military Medical CenterBethesda, MD
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Who Is Running the Clinical Trial?
Walter Reed National Military Medical CenterLead Sponsor
Uniformed Services University of the Health SciencesCollaborator