Carpal Tunnel Syndrome Clinical Trial
— ROBUSTOfficial title:
Multicenter Prospective Trial of Office-based Carpal Tunnel Release With Ultrasound Guidance (ROBUST)
Verified date | February 2024 |
Source | Sonex Health, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 149 |
Est. completion date | December 31, 2025 |
Est. primary completion date | September 24, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Georgia Hand, Shoulder & Elbow | Atlanta | Georgia |
United States | Orthopedic Associates | Fort Walton Beach | Florida |
United States | University of Nevada, Las Vegas | Las Vegas | Nevada |
United States | Bluegrass Orthopaedics | Lexington | Kentucky |
United States | New Braunfels Orthopaedic Surgery and Sports Medicine | New Braunfels | Texas |
United States | The Bone & Joint Surgery Clinic | Raleigh | North Carolina |
United States | Vero Orthopaedics | Vero Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Sonex Health, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (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 change in BCTQ-SSS score at the 3-month follow-up relative to baseline. | 3 Months | |
Secondary | Time to Return To Normal Daily Activities (RTA) | 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. | 3 Months | |
Secondary | Time to Return To Work Among Employed Subjects (RTW) | 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. | 3 Months | |
Secondary | Boston Carpal Tunnel Questionnaire - Functional Status Scale (BCTQ-FSS) | 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. | 3 Months | |
Secondary | Michigan Hand Questionnaire (MHQ) | 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. |
3 Months | |
Secondary | Numeric Pain Scale | 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. | 3 Months | |
Secondary | EuroQoL 5-Dimension 5-Level (EQ-5D-5L) | 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. | 3 Months | |
Secondary | Device and/or Procedure Related Adverse Events | Incidence of device- or procedure-related AEs within 90 days of treatment. | 3 Months | |
Secondary | Global Satisfaction | 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. | 3 Months |
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