Clinical trial NCT05675046: Multicenter Prospective Trial of Office-based Carpal Tunnel Release With Ultrasound Guidance (ROBUST)
Official title: Multicenter Prospective Trial of Office-based Carpal Tunnel Release With Ultrasound Guidance (ROBUST)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Carpal Tunnel Syndrome
CTS
Keywords: Ultrasound Guided Carpal Tunnel Release
CTR-US
Office-Based
In Office
UltraGuideCTR
Lead sponsor: Sonex Health, Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-09
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multicenter prospective single-arm trial of subjects with symptomatic Carpal Tunnel Syndrome treated with the Carpal tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in an office-based setting.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS)
timeFrame: Baseline and 3 Months
Secondary outcomes:
measure: Time to Return To Normal Daily Activities (RTA)
timeFrame: 3 Months
measure: Time to Return To Work Among Employed Subjects (RTW)
timeFrame: 3 Months
measure: Boston Carpal Tunnel Questionnaire - Functional Status Scale (BCTQ-FSS)
timeFrame: Baseline and 3 Months
measure: Michigan Hand Questionnaire (MHQ)
timeFrame: Baseline and 3 Months
measure: Numeric Pain Scale
timeFrame: Baseline and 3 Months
measure: EuroQoL 5-Dimension 5-Level (EQ-5D-5L)
timeFrame: Baseline and 3 Months
measure: Number of Participants With Device and/or Procedure Related Adverse Events
timeFrame: 3 Months
measure: Global Satisfaction
timeFrame: 3 Months
Other outcomes:
Locations:
city: Fort Walton Beach
country: United States
facility: Orthopedic Associates
state: Florida
city: Vero Beach
country: United States
facility: Vero Orthopaedics
state: Florida
city: Atlanta
country: United States
facility: Georgia Hand, Shoulder & Elbow
state: Georgia
city: Lexington
country: United States
facility: Bluegrass Orthopaedics
state: Kentucky
city: Las Vegas
country: United States
facility: University of Nevada, Las Vegas
state: Nevada
city: Raleigh
country: United States
facility: The Bone & Joint Surgery Clinic
state: North Carolina
city: New Braunfels
country: United States
facility: New Braunfels Orthopaedic Surgery and Sports Medicine
state: Texas
Study officials:
affiliation: University of Nevada, Las Vegas
name: Ashley Pistorio, MD
role: PRINCIPAL_INVESTIGATOR
References: