Trial of Ultrasound Guided Carpal Tunnel Release Versus Traditional Open Release (TUTOR)
- Conditions
- Carpal Tunnel SyndromeCTSCarpal Tunnel
- Interventions
- Device: CTR-USProcedure: mOCTR
- 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
- ≥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
- 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
- Arm && Interventions
Group Intervention Description Carpal Tunnel Release with Ultrasound Guidance (CTR-US) CTR-US - Mini Open Carpel Tunnel Release (mOCTR) mOCTR -
- Primary Outcome Measures
Name Time Method Time to Return to Work Among Employed Subjects 3 Month Follow-Up The 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.
Return to normal daily activities within 3 days postoperatively 3 Month Follow-Up The 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.
Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-SSS) Change 3 Month Follow-Up Between-group mean difference in BCTQ-FSS change scores
Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) Change 3 Month Follow-Up Between-group mean difference in BCTQ-SSS change scores
Numeric Pain Scale Change 3 Month Follow-Up Between-group mean difference in Numeric Pain Scale change scores. Scoring is 0 to 10, 0 = No pain, 10 = Worst possible pain
EuroQol 5-Dimension 5-Level (EQ-5D-5L) change 3 Month Follow-Up Between-group mean difference in EQ-5D-5L change score
Device or Procedure related Adverse Events 3 Month Follow-Up Adverse events (AEs) occurring within 90 days of treatment and that are adjudicated as definitely related or probably related to the device, or definitely related or probably related to the procedure will be included in this endpoint. The incidence of device- or procedure-related AEs within 90 days of treatment in each study group will represent a secondary endpoint of the study.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Mississippi
🇺🇸Jackson, Mississippi, United States
Twin Cities Orthopedics
🇺🇸Plymouth, Minnesota, United States
Orthopedic Associates
🇺🇸Fort Walton Beach, Florida, United States
Sierra Orthopedic Institute
🇺🇸Sonora, California, United States
Tri-State Orthopaedics
🇺🇸Evansville, Indiana, United States
Indiana Hand to Shoulder
🇺🇸Indianapolis, Indiana, United States
Midwest Orthopedic Group
🇺🇸Farmington, Missouri, United States
Sano Orthopedics
🇺🇸Lee's Summit, Missouri, United States
ATX Orthopedics
🇺🇸Austin, Texas, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Kansas Orthopaedic Center
🇺🇸Wichita, Kansas, United States