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

  • STATUS
    Recruiting
  • End date
    Mar 31, 2024
  • participants needed
    120
  • sponsor
    Sonex Health, Inc.
Updated on 22 October 2022
ultrasound guidance
carpal tunnel release

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).

Details
Condition Carpal Tunnel Syndrome, CTS, Carpal Tunnel
Treatment mOCTR, CTR-US
Clinical Study IdentifierNCT05405218
SponsorSonex Health, Inc.
Last Modified on22 October 2022

Eligibility

Yes No Not Sure

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 randomization
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
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