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

Carpal Tunnel Syndrome Clinical Trial

— TUTOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05405218
• Other study ID #: 90079-TP
• Status: Completed
• Phase: N/A
• Start date: July 26, 2022
• Est. completion date: March 30, 2024

Study information

• Verified date: March 2024
• Source: Sonex Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: March 30, 2024
• Est. primary completion date: April 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel
• Carpal Tunnel Syndrome
• CTS

Intervention

Device:
• CTR-US
Carpal Tunnel Release with Ultrasound Guidance

Procedure:
• mOCTR
Mini Open Carpal Tunnel Release

Locations

Country	Name	City	State
United States	ATX Orthopedics	Austin	Texas
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Tri-State Orthopaedics	Evansville	Indiana
United States	Midwest Orthopedic Group	Farmington	Missouri
United States	Orthopedic Associates	Fort Walton Beach	Florida
United States	Indiana Hand to Shoulder	Indianapolis	Indiana
United States	University of Mississippi	Jackson	Mississippi
United States	Sano Orthopedics	Lee's Summit	Missouri
United States	Twin Cities Orthopedics	Plymouth	Minnesota
United States	Washington University	Saint Louis	Missouri
United States	Sierra Orthopedic Institute	Sonora	California
United States	Kansas Orthopaedic Center	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Sonex Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Return to normal daily activities within 3 days postoperatively	The time to return to normal daily activities will be defined as the number of days between treatment and the time the subject reports returning to normal daily activities, irrespective of work status.	3 Month Follow-Up
Primary	Time to Return to Work Among Employed Subjects	The time to return to work will be defined as the number of days between treatment and the time the subject reports returning to work in any capacity.	3 Month Follow-Up
Primary	Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) Change	Between-group mean difference in BCTQ-SSS change scores	3 Month Follow-Up
Primary	Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-SSS) Change	Between-group mean difference in BCTQ-FSS change scores	3 Month Follow-Up
Primary	Numeric Pain Scale Change	Between-group mean difference in Numeric Pain Scale change scores. Scoring is 0 to 10, 0 = No pain, 10 = Worst possible pain	3 Month Follow-Up
Primary	EuroQol 5-Dimension 5-Level (EQ-5D-5L) change	Between-group mean difference in EQ-5D-5L change score	3 Month Follow-Up
Primary	Device or Procedure related Adverse Events	Adverse events (AEs) occurring within 90 days of treatment and that are adjudicated as definitely related or probably related to the device, or definitely related or probably related to the procedure will be included in this endpoint. The incidence of device- or procedure-related AEs within 90 days of treatment in each study group will represent a secondary endpoint of the study.	3 Month Follow-Up