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

Sonex Health

Status: Completed

Conditions: Carpal Tunnel Syndrome; CTS; Carpal Tunnel

Treatments: Procedure: mOCTR; Device: CTR with Ultrasound Guidance using the UltraGuideCTR device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05405218

90079-TP

Details and patient eligibility

About

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).

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

Carpal Tunnel Release with Ultrasound Guidance using the UltraGuideCTR device

Experimental group

Treatment:

Device: CTR with Ultrasound Guidance using the UltraGuideCTR device

Mini Open Carpal Tunnel Release (mOCTR)

Active Comparator group

Treatment:

Procedure: mOCTR