Multicenter Prospective Trial of Office-based Carpal Tunnel Release With Ultrasound Guidance (ROBUST)

Not Applicable

Active, not recruiting

Conditions: Carpal Tunnel Syndrome
CTS

Registration Number: NCT05675046

Lead Sponsor: Sonex Health, Inc.

Brief Summary: Multicenter prospective single-arm trial of subjects with symptomatic Carpal Tunnel Syndrome treated with Ultrasound Guided Carpal Tunnel Release (CTR-US) in an office-based setting.

Detailed Description: Multicenter prospective single-arm trial of subjects with symptomatic Carpal Tunnel Syndrome treated with Ultrasound Guided Carpal Tunnel Release (CTR-US) in an office-based setting reporting the safety and effectiveness of office-based carpal tunnel release with ultrasound guidance (CTR-US) in patients with symptomatic carpal tunnel syndrome (CTS).

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 149

Inclusion Criteria

≥18 years of age
Clinical diagnosis of unilateral or bilateral idiopathic CTS
CTS-6 score >12 in target hand*
Median nerve cross-sectional area ≥10 mm2 in the proximal carpal tunnel region of the target hand measured by diagnostic ultrasound*
Prior failure of one or more nonsurgical treatment options (e.g., physical activity modification, bracing, splinting, corticosteroid injection)*
Subject agrees to complete follow-up questionnaires over a 24-month period
Subject has a valid smart phone number and/or email address to receive and answer follow-up questionnaires

Exclusion Criteria

Prior surgery on the target wrist or hand with the exception of (a) trigger finger release or similar minor finger procedure (e.g., digital ganglion cyst removal, foreign body removal) that has clinically recovered, or release for DeQuervain's syndrome (1st dorsal compartment) that has clinically recovered*
History of prior surgical CTR in the target hand*
History of infection in the target hand*
History of prior surgery in the non-target hand, including CTR, within 3 months of enrollment or with persistent symptoms that interfere with normal daily activities or work at the time of consent
Planned surgical or interventional procedure on the contralateral hand within 3 months of the target hand procedure date*
Corticosteroid injection in the target hand within 6 weeks of study procedure date*
Presence of additional process in the target hand requiring additional intervention beyond carpal tunnel release (e.g. neurolysis, mass removal, tenosynovectomy)*
Clinically significant degenerative arthritis of the upper limb (shoulder to hand) on the target side*
Clinically significant inflammatory disease (including tenosynovitis) of the upper limb (shoulder to hand) on the target side*
Clinically significant trauma or deformity of the upper limb (shoulder to hand) on the target side*
Clinically significant vascular disease (including Raynaud's phenomenon) of the upper limb (shoulder to hand) on the target side*
Clinically significant neurological disorder (including complex regional pain syndrome) of the upper limb (shoulder to hand) on the target side*
Systemic inflammatory disease (e.g., rheumatoid arthritis, lupus)
Amyloidosis
Chronic renal insufficiency requiring dialysis
Diabetes not controlled by a stable dose of medication
Uncontrolled thyroid disease
Pregnant or planning pregnancy in the next 24 months
Workers' compensation subjects
Inability to provide a legally acceptable Informed Consent Form and/or comply with all follow-up requirements
Subject has other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations

Note: An asterisk (*) denotes that this criterion must be applied to the target hand for unilateral CTR-US procedures, or to both hands for simultaneous bilateral CTR-US procedures.

Clinically significant is defined as likely to interfere with the performance of the procedure in a safe and/or effective manner.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS)	Baseline and 3 Months	The Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) is a Carpal Tunnel Syndrome specific questionnaire that has been shown to be highly reproducible, internally consistent, valid, and responsive to clinical change in Carpal Tunnel Syndrome (CTS) and subject status post-carpal tunnel release (CTR). The BCTQ consists of 11 symptom severity questions (BCTQ-SSS). Scoring for the BCTQ- SSS ranges from 1 to 5, with higher scores indicating more severe symptoms, and is calculated as the mean of each response. The mean change score in BCTQ-SSS from baseline and 3-month follow-up are reported. Negative change scores indicate decreased symptom severity and positive change scores indicate increased symptom severity. Bilateral patients with both hands treated are reported based on their averaged score.

Secondary Outcome Measures

Name	Time	Method
Time to Return To Normal Daily Activities (RTA)	3 Months	Time to return to normal daily activities will be defined as the number of days between treatment and the time the subject reports returning to normal daily activities, irrespective of work status.
Time to Return To Work Among Employed Subjects (RTW)	3 Months	Time to return to work will be defined as the number of days between treatment and the time the subject reports returning to work in any capacity.
Boston Carpal Tunnel Questionnaire - Functional Status Scale (BCTQ-FSS)	Baseline and 3 Months	The Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) additionally consists of 8 functional status questions. Scoring for the BCTQ-FSS ranges from 1 to 5, with higher scores indicating more functional limitation, and is calculated as the mean of each response. The mean change score in BCTQ-FSS from baseline to the 3-month follow-up are reported. Negative change scores indicate decreased functional limitation and positive change scores indicate increased functional limitation.
Michigan Hand Questionnaire (MHQ)	Baseline and 3 Months	Michigan Hand Questionnaire (MHQ) is a validated, hand-specific questionnaire consisting of 37 questions in 6 domains: * Overall hand function * Activities of daily living * Work performance * Pain * Aesthetics * Satisfaction The total score ranges from 0 to 100. Higher scores indicate better hand performance; lower scores indicate lower hand performance. Mean change in the total MHQ score at the 3-month follow-up relative to baseline is reported.
Numeric Pain Scale	Baseline and 3 Months	The Numeric Pain Scale measures pain severity. Scoring for the Numeric Pain Scale ranges from 0 (indicating no pain) to 10 (indicating worst pain possible). The mean change scores in the Numeric Pain Scale from baseline and 3-month follow-up are reported. Negative change scores indicate decreased pain severity and positive change scores indicate increased pain severity. Bilateral patients with both hands treated are reported based on their averaged score.
EuroQoL 5-Dimension 5-Level (EQ-5D-5L)	Baseline and 3 Months	The EuroQol 5-Dimension 5-Level (EQ-5D-5L) is a generic preference-based questionnaire developed by the EuroQol Group to measure health-related quality of life. The EQ-5D-5L measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking consisting of: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. Scoring for the EQ-5D-5L ranges from -0.57 (indicating lowest quality of life) to 1.00 (indicating highest quality of life). The mean change score in the EQ-5D-5L from baseline to the 3-month follow-up are reported. Negative change scores indicate decreased quality of life and positive change scores indicate increased quality of life.
Number of Participants With Device and/or Procedure Related Adverse Events	3 Months	Participants with adverse events (AEs) occurring within 90 days of treatment and that are adjudicated as definitely related or probably related to the device or definitely related or probably related to the procedure will be included in this endpoint. The number of device- or procedure-related AEs within 90 days of treatment will represent an endpoint of the study.
Global Satisfaction	3 Months	Subjects were asked to rate their satisfaction with the carpal tunnel release procedure. The global satisfaction scale ranges from 1 to 5, with 1 = Very Dissatisfied, 2 = Dissatisfied, 3 = Neither Satisfied nor Dissatisfied, 4 = Satisfied and 5 = Very Satisfied. The mean satisfaction score at the 3-month follow-up is reported. Bilateral patients with both hands treated are reported based on their averaged score. Higher scores indicate higher satisfaction; lower scores indicate lower satisfaction.

Trial Locations

Locations (7): Orthopedic Associates
🇺🇸
Fort Walton Beach, Florida, United States
Vero Orthopaedics
🇺🇸
Vero Beach, Florida, United States
Georgia Hand, Shoulder & Elbow
🇺🇸
Atlanta, Georgia, United States
Bluegrass Orthopaedics
🇺🇸
Lexington, Kentucky, United States
University of Nevada, Las Vegas
🇺🇸
Las Vegas, Nevada, United States
The Bone & Joint Surgery Clinic
🇺🇸
Raleigh, North Carolina, United States
New Braunfels Orthopaedic Surgery and Sports Medicine
🇺🇸
New Braunfels, Texas, United States
Orthopedic Associates
🇺🇸Fort Walton Beach, Florida, United States