Research Study: TUTOR

Trial of Ultrasound guided carpal tunnel release versus Traditional Open Release

Sonex Health aims 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). This is a randomized controlled trial with symptomatic CTS who will be randomized at a ratio of 2:1 to treat with CTR with UltraSound or a mini-open CTR procedure. We will be looking at time to return to work as the main data point for study outcomes.

Are you eligible to participate in this study?

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 randomization
  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

What do you need to know?

Participation in research is entirely voluntary. If you think you qualify to be part of this study, ask your doctor about participation.

Contact us if you are eligible and interested in this study

Please contact Lexie Reissaus, Clinical Research Manager at

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