Multicenter Prospective Trial of Office-based Carpal Tunnel Release With Ultrasound Guidance (ROB… (NCT05675046) | Clinical Trial Compass
CompletedNot Applicable
Multicenter Prospective Trial of Office-based Carpal Tunnel Release With Ultrasound Guidance (ROBUST)
United States149 participantsStarted 2023-02-16
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS)
. 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\*