NCT04504019

Clinical Outcomes of USCTR vs. mOCTR

Clinical Outcomes of Carpal Tunnel Release With and Without Ultrasound Guidance

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Walter Reed National Military Medical Center · Federal
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	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
PROCEDURE	mOCTR	Mini-open CTR via a single 1-3cm palmar incision

Timeline

• Start date: 2021-03-02
• Primary completion: 2023-09-05
• Completion: 2025-08-06
• First posted: 2020-08-07
• Last updated: 2025-09-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study