Carpal Tunnel Release Using Ultrasound

Terminated

• Conditions: Carpal Tunnel Syndrome
• Interventions: Procedure: Carpal Tunnel Release

• Registration Number: NCT05031338
• Lead Sponsor: Sonex Health, Inc.

Brief Summary

The goal of the Carpal Tunnel Release Using Ultrasound registry (CiTRUS Registry) is to collect experience information from patients scheduled to undergo carpal tunnel release surgery with either the SX-One MicroKnife® with ultrasound guidance or the traditional mini-open technique without US guidance.

Detailed Description

The CiTRUS registry is an observational study designed to better understand the overall patient experience following a carpal tunnel release surgery using either the SX-One MicroKnife with ultrasound guidance or the traditional mini-open technique without ultrasound guidance. The determination of which surgical technique to uses will be determined by the treating physician and the patient. The patient registry outcomes are intended to help direct future clinical care, educate patients with carpal tunnel syndrome, and design future research.

Study Timeline

• Study Start: 2021-07-02
• Study First Submitted: 2021-08-26
• Study First Submitted QC: 2021-08-26
• Study First Posted: 2021-09-01
• Status Verified: 2022-08
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-15
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 411

Inclusion Criteria

• Scheduled to undergo carpal tunnel release surgery on the right and/or left wrist using either the SX-One MicroKnife with US guidance or the traditional mini-open technique without US guidance
• 18 years of age or older
• Agree to complete questionnaires over a 12-month period
• Valid mobile phone number and email address to receive and answer questions

Exclusion Criteria

• Age less than 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SX-One MicroKnife with ultrasound guidance	Carpal Tunnel Release	Carpal Tunnel Release using the SX-One MicroKnife with ultrasound guidance
Traditional mini-open technique without ultrasound guidance	Carpal Tunnel Release	Carpal Tunnel Release using the traditional mini-open technique without ultrasound guidance

Primary Outcome Measures

Name	Time	Method
Change from baseline Quick Form of the Disabilities of the Shoulder and Hand scores at 12 months	12 months	To assess the overall patient experience following carpal tunnel release using either the SX-One MicroKnife® with ultrasound (US) guidance or the traditional mini-open technique without ultrasound guidance patients will complete the Quick Form of the Disabilities of the Shoulder and Hand scale. The Quick Form of the Disabilities of the Shoulder and Hand scale consists of 11 items scored 1-5 with lower scores indicating less symptoms or better function.
Change from baseline Boston Carpal Tunnel Questionnaire scores at 12 months	12 months	To assess the overall patient experience following carpal tunnel release using either the SX-One MicroKnife® with ultrasound guidance or the traditional mini-open technique without ultrasound guidance patients will complete the Boston Carpal Tunnel Questionnaire at 12 months. The Boston Carpal Tunnel Questionnaire consists of two subscales: symptom severity (11 items scored 1-5) and functional status (8 items scored 1-5) with lower scores indicating less symptoms or better function.

Secondary Outcome Measures

Name	Time	Method
Patient reported time to return to activities	Post-operative days 1-14, 2 weeks, 1,3,6 and 12 months	Patient reported time to return to normal activities as measured in days.

Trial Locations

Locations (1)

Sonex Health, Inc.; 🇺🇸 Eagan, Minnesota, United States