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

Study Overview
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Brief Summary
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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).

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

Conditions
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CTS, Carpal Tunnel Syndrome, Carpal Tunnel

Intervention / Treatment
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* Device: CTR-US
* Procedure: mOCTR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carpal Tunnel Release with Ultrasound Guidance (CTR-US)<br> | Device: CTR-US<br>* Carpal Tunnel Release with Ultrasound Guidance<br>|
| Active Comparator: Mini Open Carpel Tunnel Release (mOCTR)<br> | Procedure: mOCTR<br>* Mini Open Carpal Tunnel Release<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return to normal daily activities within 3 days postoperatively | 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. | 3 Month Follow-Up | 
| Time to Return to Work Among Employed Subjects | 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. | 3 Month Follow-Up | 
| Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) Change | Between-group mean difference in BCTQ-SSS change scores | 3 Month Follow-Up | 
| Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-SSS) Change | Between-group mean difference in BCTQ-FSS change scores | 3 Month Follow-Up | 
| Numeric Pain Scale Change | Between-group mean difference in Numeric Pain Scale change scores. Scoring is 0 to 10, 0 = No pain, 10 = Worst possible pain | 3 Month Follow-Up | 
| EuroQol 5-Dimension 5-Level (EQ-5D-5L) change | Between-group mean difference in EQ-5D-5L change score | 3 Month Follow-Up | 
| Device or Procedure related Adverse Events | 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. | 3 Month Follow-Up |