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

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).

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome; CTS; Carpal Tunnel
• Intervention / Treatment: Procedure: mOCTR; Device: CTR with Ultrasound Guidance using the UltraGuideCTR device

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sonora, California, United States, 95370
      • Sierra Orthopedic Institute
  • Florida
    • Fort Walton Beach, Florida, United States, 32547
      • Orthopedic Associates
  • Indiana
    • Evansville, Indiana, United States, 47715
      • Tri-State Orthopaedics
    • Indianapolis, Indiana, United States, 46260
      • Indiana Hand to Shoulder
  • Kansas
    • Wichita, Kansas, United States, 67205
      • Kansas Orthopaedic Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Minnesota
    • Plymouth, Minnesota, United States, 55441
      • Twin Cities Orthopedics
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi
  • Missouri
    • Farmington, Missouri, United States, 63640
      • Midwest Orthopedic Group
    • Lee's Summit, Missouri, United States, 64064
      • Sano Orthopedics
    • Saint Louis, Missouri, United States, 63129
      • Washington University
  • Texas
    • Austin, Texas, United States, 78756
      • ATX Orthopedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carpal Tunnel Release with Ultrasound Guidance using the UltraGuideCTR device	Device: CTR with Ultrasound Guidance using the UltraGuideCTR device; Carpal Tunnel Release with Ultrasound Guidance using UltraGuideCTR device
Active Comparator: Mini Open Carpal Tunnel Release (mOCTR)	Procedure: mOCTR; Mini Open Carpal Tunnel Release

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) Change	The Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) is a Carpal Tunnel Syndrome specific questionnaire that has been shown to be highly reproducible, internally consistent, valid, and responsive to clinical change in Carpal Tunnel Syndrome (CTS) and subject status post-carpal tunnel release (CTR). The BCTQ consists of 11 symptom severity questions (BCTQ-SSS). Scoring for the BCTQ- SSS ranges from 1 to 5, with higher scores indicating more severe symptoms, and is calculated as the mean of each response. The mean change scores in BCTQ-SSS from baseline to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased symptom severity and positive change scores indicate increased symptom severity.	3 Month Follow-Up
Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) Change	The Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) additionally consists of 8 functional status questions. Scoring for the BCTQ-FSS ranges from 1 to 5, with higher scores indicating more functional limitation, and is calculated as the mean of each response. The mean change scores in BCTQ-FSS from baseline to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased functional limitation and positive change scores indicate increased functional limitation.	3 Month Follow-Up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Participants With Device or Procedure Related Adverse Events	Participants with 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 an endpoint of the study.	3 Month Follow-Up
Numeric Pain Scale Change	The Numeric Pain Scale measures pain severity. Scoring for the Numeric Pain Scale ranges from 0 (indicating no pain) to 10 (indicating worst pain possible). The mean change scores in the Numeric Pain Scale from baseline to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased pain severity and positive change scores indicate increased pain severity.	3 Month Follow-Up
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Change	The EuroQol 5-Dimension 5-Level (EQ-5D-5L) is a generic preference-based questionnaire developed by the EuroQol Group to measure health-related quality of life. The EQ-5D-5L measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking consisting of: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. Scoring for the EQ-5D-5L ranges from -0.57 (indicating lowest quality of life) to 1.00 (indicating highest quality of life). The mean change scores in the EQ-5D-5L from baseline to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased quality of life and positive change scores indicate increased quality of life.	3 Month Follow-Up
Participants Who Returned 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

Collaborators and Investigators

• Sponsor: Sonex Health, Inc.
• Investigators: Principal Investigator: Kyle Eberlin, MD, Massachusetts General Hospital

Publications and helpful links

General Publications

• Eberlin KR, Dy CJ, Fischer MD, Gluck JL, Kaplan FTD, McDonald TJ, Miller LE, Palmer A, Walker ME, Watt JF. Trial of ultrasound guided carpal tunnel release versus traditional open release (TUTOR). Medicine (Baltimore). 2022 Oct 14;101(41):e30775. doi: 10.1097/MD.0000000000030775.

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2022
• Primary Completion (Actual): April 6, 2023
• Study Completion (Actual): March 30, 2024

Study Registration Dates

• First Submitted: May 31, 2022
• First Submitted That Met QC Criteria: May 31, 2022
• First Posted (Actual): June 6, 2022

Study Record Updates

• Last Update Posted (Estimated): June 5, 2025
• Last Update Submitted That Met QC Criteria: May 16, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Median Neuropathy; Mononeuropathies; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome
• Other Study ID Numbers: 90079-TP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No