Trial of Ultrasound Guided Carpal Tunnel Release Versus Traditional Open Release (TUTOR)
NCT ID: NCT05405218
Last Updated: 2025-06-05
Study Results
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View full resultsBasic Information
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COMPLETED
NA
122 participants
INTERVENTIONAL
2022-08-08
2024-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Carpal Tunnel Release with Ultrasound Guidance using the UltraGuideCTR device
CTR with Ultrasound Guidance using the UltraGuideCTR device
Carpal Tunnel Release with Ultrasound Guidance using UltraGuideCTR device
Mini Open Carpal Tunnel Release (mOCTR)
mOCTR
Mini Open Carpal Tunnel Release
Interventions
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CTR with Ultrasound Guidance using the UltraGuideCTR device
Carpal Tunnel Release with Ultrasound Guidance using UltraGuideCTR device
mOCTR
Mini Open Carpal Tunnel Release
Eligibility Criteria
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Inclusion Criteria
2. Clinical diagnosis of unilateral or bilateral idiopathic CTS
3. CTS-6 score \>12 in target hand
4. 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
5. Median nerve cross-sectional area ≥10 mm2 in the proximal carpal tunnel region of the target hand measured by diagnostic ultrasound
6. Prior failure of one or more nonsurgical treatment options for the target hand (e.g., physical activity modification, bracing, splinting, corticosteroid injection)
7. Subject agrees to complete follow-up questionnaires over a 12-month period
8. Subject has a valid mobile phone number and email address to receive and answer follow-up questionnaires
Exclusion Criteria
2. History of prior surgical CTR procedure in the target hand
3. 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
4. Corticosteroid injection in the target wrist or hand within 6 weeks of study procedure date
5. Presence of additional process in the target wrist or hand requiring additional intervention beyond carpal tunnel release (e.g. neurolysis, mass removal, tenosynovectomy)
6. Clinically significant degenerative arthritis of the upper limb (shoulder to hand) on the target side
7. Clinically significant inflammatory disease (including tenosynovitis) of the upper limb (shoulder to hand) on the target side
8. Clinically significant trauma or deformity of the upper limb (shoulder to hand) on the target side
9. Clinically significant vascular disease (including Raynaud's phenomenon) of the upper limb (shoulder to hand) on the target side
10. Clinically significant neurological disorder (including complex regional pain syndrome) of the upper limb (shoulder to hand) on the target side
11. Planned surgical or interventional procedure on the contralateral wrist or hand
12. Systemic inflammatory disease (e.g., rheumatoid arthritis, lupus)
13. Amyloidosis
14. Chronic renal insufficiency requiring dialysis
15. Diabetes not controlled by a stable dose of medication over the past three months
16. Uncontrolled thyroid disease
17. Pregnant or planning pregnancy in the next 12 months
18. Workers compensation subjects
19. Inability to provide a legally acceptable Informed Consent Form and/or comply with all follow-up requirements
20. 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
18 Years
ALL
No
Sponsors
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Sonex Health, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Kyle Eberlin, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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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
Washington University
St Louis, Missouri, United States
ATX Orthopedics
Austin, Texas, United States
Countries
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References
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Eberlin KR, Amis BP, Berkbigler TP, Dy CJ, Fischer MD, Gluck JL, Kaplan FTD, McDonald TJ, Miller LE, Palmer A, Perry PE, Walker ME, Watt JF. Multicenter randomized trial of carpal tunnel release with ultrasound guidance versus mini-open technique. Expert Rev Med Devices. 2023 Jul;20(7):597-605. doi: 10.1080/17434440.2023.2218548. Epub 2023 May 30.
Eberlin KR, Dy CJ, Fischer MD, Gluck JL, Kaplan FTD, McDonald TJ, Miller LE, Palmer A, Walker ME, Watt JF. Trial of ultrasound guided carpal tunnel release versus traditional open release (TUTOR). Medicine (Baltimore). 2022 Oct 14;101(41):e30775. doi: 10.1097/MD.0000000000030775.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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90079-TP
Identifier Type: -
Identifier Source: org_study_id
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