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

NCT05405218 | Completed Results DMC FDA Device

• 1 other identifier: 90079-TP
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 12

Brief 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).

Conditions

Carpal Tunnel Syndrome; CTS; Carpal Tunnel

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Participants With Device or Procedure Related Adverse Events

  3 Month Follow-Up

• Numeric Pain Scale Change

  3 Month Follow-Up

• EuroQol 5-Dimension 5-Level (EQ-5D-5L) Change

  3 Month Follow-Up

Study Arms (2)

Carpal Tunnel Release with Ultrasound Guidance using the UltraGuideCTR device

EXPERIMENTAL

Device: CTR with Ultrasound Guidance using the UltraGuideCTR device

Mini Open Carpal Tunnel Release (mOCTR)

ACTIVE COMPARATOR

Procedure: mOCTR

Interventions

CTR with Ultrasound Guidance using the UltraGuideCTR device DEVICE

Carpal Tunnel Release with Ultrasound Guidance using UltraGuideCTR device

Carpal Tunnel Release with Ultrasound Guidance using the UltraGuideCTR device

mOCTR PROCEDURE

Mini Open Carpal Tunnel Release

Mini Open Carpal Tunnel Release (mOCTR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age
• Clinical diagnosis of unilateral or bilateral idiopathic CTS
• CTS-6 score \>12 in target hand
• 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
• Median nerve cross-sectional area ≥10 mm2 in the proximal carpal tunnel region of the target hand measured by diagnostic ultrasound
• Prior failure of one or more nonsurgical treatment options for the target hand (e.g., physical activity modification, bracing, splinting, corticosteroid injection)
• Subject agrees to complete follow-up questionnaires over a 12-month period
• Subject has a valid mobile phone number and email address to receive and answer follow-up questionnaires

You may not qualify if:

• Prior surgery on the target wrist or hand with the exception of trigger finger that has clinically recovered
• History of prior surgical CTR procedure in the target hand
• 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
• Corticosteroid injection in the target wrist or hand within 6 weeks of study procedure date
• Presence of additional process in the target wrist or hand requiring additional intervention beyond carpal tunnel release (e.g. neurolysis, mass removal, tenosynovectomy)
• Clinically significant degenerative arthritis of the upper limb (shoulder to hand) on the target side
• Clinically significant inflammatory disease (including tenosynovitis) of the upper limb (shoulder to hand) on the target side
• Clinically significant trauma or deformity of the upper limb (shoulder to hand) on the target side
• Clinically significant vascular disease (including Raynaud's phenomenon) of the upper limb (shoulder to hand) on the target side
• Clinically significant neurological disorder (including complex regional pain syndrome) of the upper limb (shoulder to hand) on the target side
• Planned surgical or interventional procedure on the contralateral wrist or hand
• Systemic inflammatory disease (e.g., rheumatoid arthritis, lupus)
• Amyloidosis
• Chronic renal insufficiency requiring dialysis
• Diabetes not controlled by a stable dose of medication over the past three months

Sponsors & Collaborators

• Sonex Health, Inc.: lead

Study Sites (12)

Sierra Orthopedic Institute

Sonora, California, 95370, United States

Location

Orthopedic Associates

Fort Walton Beach, Florida, 32547, United States

Location

Tri-State Orthopaedics

Evansville, Indiana, 47715, United States

Location

Indiana Hand to Shoulder

Indianapolis, Indiana, 46260, United States

Location

Kansas Orthopaedic Center

Wichita, Kansas, 67205, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Twin Cities Orthopedics

Plymouth, Minnesota, 55441, United States

Location

University of Mississippi

Jackson, Mississippi, 39216, United States

Location

Midwest Orthopedic Group

Farmington, Missouri, 63640, United States

Location

Sano Orthopedics

Lee's Summit, Missouri, 64064, United States

Location

Washington University

St Louis, Missouri, 63129, United States

Location

ATX Orthopedics

Austin, Texas, 78756, United States

Location

Related Publications (2)

• Eberlin KR, Amis BP, Berkbigler TP, Dy CJ, Fischer MD, Gluck JL, Kaplan FTD, McDonald TJ, Miller LE, Palmer A, Perry PE, Walker ME, Watt JF. Multicenter randomized trial of carpal tunnel release with ultrasound guidance versus mini-open technique. Expert Rev Med Devices. 2023 Jul;20(7):597-605. doi: 10.1080/17434440.2023.2218548. Epub 2023 May 30.

  PMID: 37254502 DERIVED

• 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.

  PMID: 36254038 DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Median Neuropathy

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Results Point of Contact

• Title: Amy Stegner, Vice President Clinical Affairs
• Organization: Sonex Health, Inc.

astegner@sonexhealth.com

(888) 518-8780

Study Officials

• Kyle Eberlin, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 6, 2022
• Study Start: August 8, 2022
• Primary Completion: April 6, 2023
• Study Completion: March 30, 2024
• Last Updated: June 5, 2025
• Results First Posted: June 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)