Clinical trial NCT05405218: Trial of Ultrasound Guided Carpal Tunnel Release Versus Traditional Open Release (TUTOR)
Official title: Trial of Ultrasound Guided Carpal Tunnel Release Versus Traditional Open Release (TUTOR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
CTS
Carpal Tunnel
Lead sponsor: Sonex Health, Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-06
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

1. ≥18 years of age
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:

1. Prior surgery on the target wrist or hand with the exception of trigger finger that has clinically recovered
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

Primary outcomes:
measure: Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) Change
timeFrame: 3 Month Follow-Up
measure: Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) Change
timeFrame: 3 Month Follow-Up
Secondary outcomes:
Other outcomes:
measure: Participants With Device or Procedure Related Adverse Events
timeFrame: 3 Month Follow-Up
measure: Numeric Pain Scale Change
timeFrame: 3 Month Follow-Up
measure: EuroQol 5-Dimension 5-Level (EQ-5D-5L) Change
timeFrame: 3 Month Follow-Up
measure: Time to Return to Work Among Employed Subjects
timeFrame: 3 Month Follow-Up
measure: Participants Who Returned to Normal Daily Activities Within 3 Days Postoperatively
timeFrame: 3 Month Follow-Up
Locations:
city: Sonora
country: United States
facility: Sierra Orthopedic Institute
state: California
city: Fort Walton Beach
country: United States
facility: Orthopedic Associates
state: Florida
city: Evansville
country: United States
facility: Tri-State Orthopaedics
state: Indiana
city: Indianapolis
country: United States
facility: Indiana Hand to Shoulder
state: Indiana
city: Wichita
country: United States
facility: Kansas Orthopaedic Center
state: Kansas
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Plymouth
country: United States
facility: Twin Cities Orthopedics
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi
state: Mississippi
city: Farmington
country: United States
facility: Midwest Orthopedic Group
state: Missouri
city: Lee's Summit
country: United States
facility: Sano Orthopedics
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Austin
country: United States
facility: ATX Orthopedics
state: Texas
Study officials:
affiliation: Massachusetts General Hospital
name: Kyle Eberlin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.