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

Carpal Tunnel Syndrome Clinical Trial

— ROBUST  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05675046
• Other study ID #: 90098-TP
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 16, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Sonex Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• CTS

Intervention

Device:
• Ultrasound Guided Carpal Tunnel Release (CTR-US)
The UltraGuideCTR is a commercially available medical device specifically developed to facilitate CTR-US. The device is a single-use, hand-held device that is inserted into the carpal tunnel through a small (typically < 5 mm) wrist incision using continuous US guidance. The working tip of the UltraGuideCTR consists of two inflatable balloons that border a centrally located, retractable retrograde cutting knife. When inflated with sterile saline, the balloons increase the diameter of the tip from 4 mm to 8 mm. After the tip is positioned within the transverse safe zone of the carpal tunnel, the balloons are inflated to create space in the carpal tunnel, the blade is activated, and the TCL is transected in a retrograde manner. Following TCL transection, the blade is recessed, the balloons deflated, and the device is removed. The TCL is probed to ensure a complete release. The entire procedure is performed using US guidance.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sonex Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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