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

Not Applicable

Active, not recruiting

• Conditions: Carpal Tunnel Syndrome; CTS
• Interventions: Device: Ultrasound Guided Carpal Tunnel Release (CTR-US)

• 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).

Study Timeline

• Study First Submitted: 2022-12-29
• Study First Submitted QC: 2022-12-29
• Study First Posted: 2023-01-09
• Study Start: 2023-02-16
• Primary Completion: 2023-09-24
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 149

Inclusion Criteria

1. ≥18 years of age
2. Clinical diagnosis of unilateral or bilateral idiopathic CTS
3. CTS-6 score >12 in target hand*
4. Median nerve cross-sectional area ≥10 mm2 in the proximal carpal tunnel region of the target hand measured by diagnostic ultrasound*
5. Prior failure of one or more nonsurgical treatment options (e.g., physical activity modification, bracing, splinting, corticosteroid injection)*
6. Subject agrees to complete follow-up questionnaires over a 24-month period
7. Subject has a valid smart phone number and/or email address to receive and answer follow-up questionnaires

Exclusion Criteria

1. 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*
2. History of prior surgical CTR in the target hand*
3. History of infection in the target hand*
4. 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
5. Planned surgical or interventional procedure on the contralateral hand within 3 months of the target hand procedure date*
6. Corticosteroid injection in the target hand within 6 weeks of study procedure date*
7. Presence of additional process in the target hand requiring additional intervention beyond carpal tunnel release (e.g. neurolysis, mass removal, tenosynovectomy)*
8. Clinically significant degenerative arthritis of the upper limb (shoulder to hand) on the target side*
9. Clinically significant inflammatory disease (including tenosynovitis) of the upper limb (shoulder to hand) on the target side*
10. Clinically significant trauma or deformity of the upper limb (shoulder to hand) on the target side*
11. Clinically significant vascular disease (including Raynaud's phenomenon) of the upper limb (shoulder to hand) on the target side*
12. Clinically significant neurological disorder (including complex regional pain syndrome) of the upper limb (shoulder to hand) on the target side*
13. Systemic inflammatory disease (e.g., rheumatoid arthritis, lupus)
14. Amyloidosis
15. Chronic renal insufficiency requiring dialysis
16. Diabetes not controlled by a stable dose of medication
17. Uncontrolled thyroid disease
18. Pregnant or planning pregnancy in the next 24 months
19. Workers' compensation subjects
20. Inability to provide a legally acceptable Informed Consent Form and/or comply with all follow-up requirements
21. 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

Arm && Interventions

Group	Intervention	Description
CTR-US	Ultrasound Guided Carpal Tunnel Release (CTR-US)	Ultrasound Guided Carpal Tunnel Release (CTR-US)

Primary Outcome Measures

Name	Time	Method
Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS)	3 Months	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 change in BCTQ-SSS score at the 3-month follow-up relative to baseline.

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.
Numeric Pain Scale	3 Months	Subjects will be asked to rate their wrist pain severity on a scale of 0 to 10, where 0 represents "no pain" and 10 represents "worst possible pain". The change in Numeric Pain Scale score at the 3-month follow-up relative to baseline.
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.
Device and/or Procedure Related Adverse Events	3 Months	Incidence of device- or procedure-related AEs within 90 days of treatment.
Global Satisfaction	3 Months	Subjects will be asked to rate their satisfaction with the carpal tunnel release procedure and how likely they are to recommend their carpal tunnel release procedure to a friend or colleague.
EuroQoL 5-Dimension 5-Level (EQ-5D-5L)	3 Months	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. The change in EQ-5D-5L score at the 3-month follow-up relative to baseline.
Boston Carpal Tunnel Questionnaire - Functional Status Scale (BCTQ-FSS)	3 Months	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 change in BCTQ-FSS score at the 3-month follow-up relative to baseline.
Michigan Hand Questionnaire (MHQ)	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; Change in the total MHQ score as well as each of its 6 domains score at the 3-month follow-up relative to baseline.

Trial Locations

Locations (7)

The Bone & Joint Surgery Clinic; 🇺🇸 Raleigh, North Carolina, United States

Orthopedic Associates; 🇺🇸 Fort Walton Beach, Florida, United States

Georgia Hand, Shoulder & Elbow; 🇺🇸 Atlanta, Georgia, United States

University of Nevada, Las Vegas; 🇺🇸 Las Vegas, Nevada, United States

Vero Orthopaedics; 🇺🇸 Vero Beach, Florida, United States

Bluegrass Orthopaedics; 🇺🇸 Lexington, Kentucky, United States

New Braunfels Orthopaedic Surgery and Sports Medicine; 🇺🇸 New Braunfels, Texas, United States