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

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 withnormal daily activities or work at the time of consent and are not anticipated tointerfere with return to activities or return to work within at least 3 monthspost-operatively

5. Median nerve cross-sectional area ≥10 mm2 in the proximal carpal tunnel region ofthe 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 answerfollow-up questionnaires

Exclusion Criteria:

1. Prior surgery on the target wrist or hand with the exception of trigger finger thathas 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 ofenrollment or with persistent symptoms that interfere with normal daily activitiesor work at the time of consent

4. Corticosteroid injection in the target wrist or hand within 6 weeks of studyprocedure date

5. Presence of additional process in the target wrist or hand requiring additionalintervention 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 upperlimb (shoulder to hand) on the target side

8. Clinically significant trauma or deformity of the upper limb (shoulder to hand) onthe target side

9. Clinically significant vascular disease (including Raynaud's phenomenon) of theupper limb (shoulder to hand) on the target side

10. Clinically significant neurological disorder (including complex regional painsyndrome) 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 withall follow-up requirements

20. Subject has other medical, social or psychological conditions that, in the opinionof the investigator, preclude them from receiving the pre-treatment, requiredtreatment, and post-treatment procedures and evaluations