Trial of Ultrasound Guided Carpal Tunnel Release Versus Traditional Open Release (TUTOR)

Not Applicable

Completed

Conditions: Carpal Tunnel Syndrome
CTS
Carpal Tunnel

Registration Number: NCT05405218

Lead Sponsor: Sonex Health, Inc.

Brief Summary: Study to compare the safety and effectiveness of carpal tunnel release with ultrasound guidance (CTR-US) vs. mini-open carpal tunnel release (mOCTR) in patients with symptomatic carpal tunnel syndrome (CTS).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 122

Inclusion Criteria

≥18 years of age
Clinical diagnosis of unilateral or bilateral idiopathic CTS
CTS-6 score >12 in target hand
Absence of carpal tunnel symptoms in the contralateral hand that interfere with normal daily activities or work at the time of consent and are not anticipated to interfere with return to activities or return to work within at least 3 months post-operatively
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 for the target hand (e.g., physical activity modification, bracing, splinting, corticosteroid injection)
Subject agrees to complete follow-up questionnaires over a 12-month period
Subject has a valid mobile phone number and email address to receive and answer follow-up questionnaires

Exclusion Criteria

Prior surgery on the target wrist or hand with the exception of trigger finger that has clinically recovered
History of prior surgical CTR procedure in the target hand
History of prior surgical CTR in the contralateral hand within 3 months of enrollment or with persistent symptoms that interfere with normal daily activities or work at the time of consent
Corticosteroid injection in the target wrist or hand within 6 weeks of study procedure date
Presence of additional process in the target wrist or 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
Clinically significant inflammatory disease (including tenosynovitis) of the upper limb (shoulder to hand) on the target side
Clinically significant trauma or deformity of the upper limb (shoulder to hand) on the target side
Clinically significant vascular disease (including Raynaud's phenomenon) of the upper limb (shoulder to hand) on the target side
Clinically significant neurological disorder (including complex regional pain syndrome) of the upper limb (shoulder to hand) on the target side
Planned surgical or interventional procedure on the contralateral wrist or hand
Systemic inflammatory disease (e.g., rheumatoid arthritis, lupus)
Amyloidosis
Chronic renal insufficiency requiring dialysis
Diabetes not controlled by a stable dose of medication over the past three months
Uncontrolled thyroid disease
Pregnant or planning pregnancy in the next 12 months
Workers compensation subjects
Inability to provide a legally acceptable Informed Consent Form and/or comply with all follow-up requirements
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) Change	3 Month Follow-Up	The Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) is a Carpal Tunnel Syndrome specific questionnaire that has been shown to be highly reproducible, internally consistent, valid, and responsive to clinical change in Carpal Tunnel Syndrome (CTS) and subject status post-carpal tunnel release (CTR). The BCTQ consists of 11 symptom severity questions (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 mean change scores in BCTQ-SSS from baseline to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased symptom severity and positive change scores indicate increased symptom severity.
Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) Change	3 Month Follow-Up	The Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) additionally consists of 8 functional status questions. 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 mean change scores in BCTQ-FSS from baseline to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased functional limitation and positive change scores indicate increased functional limitation.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (12): Sierra Orthopedic Institute
🇺🇸
Sonora, California, United States
Orthopedic Associates
🇺🇸
Fort Walton Beach, Florida, United States
Tri-State Orthopaedics
🇺🇸
Evansville, Indiana, United States
Indiana Hand to Shoulder
🇺🇸
Indianapolis, Indiana, United States
Kansas Orthopaedic Center
🇺🇸
Wichita, Kansas, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Twin Cities Orthopedics
🇺🇸
Plymouth, Minnesota, United States
University of Mississippi
🇺🇸
Jackson, Mississippi, United States
Midwest Orthopedic Group
🇺🇸
Farmington, Missouri, United States
Sano Orthopedics
🇺🇸
Lee's Summit, Missouri, United States
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Sierra Orthopedic Institute
🇺🇸Sonora, California, United States