Registry of the Patient Experience for Carpal Tunnel Release

Last updated: May 16, 2025
Sponsor: Sonex Health, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carpal Tunnel Syndrome

Treatment

Open CTR

Ultrasound Guided Carpal Tunnel Release (CTR-US)

Endocscopic CTR

Clinical Study ID

NCT06071468
90154-TP
  • Ages > 18
  • All Genders

Study Summary

Multi-center study to collect large scale, multidimensional real-world data on patients undergoing carpal tunnel release (CTR).

Eligibility Criteria

Inclusion

Inclusion Criteria 1. ≥18 years of age 2. Clinical diagnosis of unilateral or bilateral CTS 3. A clinical decision has been made to perform CTR on one or both hands 4. CTS-6 score ≥12 in the target hand(s)* 5. Confirmatory diagnostic testing in the target hand(s)*:

  1. CTR-US: Confirmatory diagnostic testing with ultrasound (median nervecross-sectional area ≥10 mm2 in the proximal carpal tunnel region)

  2. ECTR or OCTR: Confirmatory electrodiagnostic testing 6. Prior failure of one or morenonsurgical treatment options (e.g., physical activity modification, bracing,splinting, corticosteroid injection) in the target hand(s) 7. Patient agrees tocomplete follow-up questionnaires over a 24-month period 8. Patient has a validsmart phone number and/or email address to receive and answer follow-upquestionnaires

Note: An asterisk (*) denotes that this criterion must be applied to the target hand for unilateral CTR procedures, or to both hands for simultaneous bilateral CTR procedures.

Exclusion

Exclusion Criteria:

  1. Patient meets any of the contraindications per Instruction For Use (IFU)

  2. Patient has other medical, social, or psychological conditions that, in the opinionof the investigator, preclude them from completing all registry requirements.

Study Design

Total Participants: 2000
Treatment Group(s): 4
Primary Treatment: Open CTR
Phase:
Study Start date:
January 26, 2024
Estimated Completion Date:
December 31, 2027

Study Description

Multicenter prospective Registry of patients with symptomatic carpal tunnel syndrome (CTS) treated (unilateral or simultaneous bilateral) by Ultrasound guided CTR (CTR-US), Endoscopic CTR (ECTR), or Open CTR (OCTR).

Connect with a study center

  • The Orthopaedic Group P.C. (CTR-US)

    Foley, Alabama 36535
    United States

    Active - Recruiting

  • Phoenix Hand

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • Phoenix Hand (CTR-US)

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • Orthopaedics Associates of Hartford (OCTR)

    Glastonbury, Connecticut 06033
    United States

    Active - Recruiting

  • Aventura Hand Center

    Aventura, Florida 33180
    United States

    Active - Recruiting

  • Aventura Hand Center (CTR-US)

    Aventura, Florida 33180
    United States

    Site Not Available

  • Orthopaedic Associates (CTR-US)

    Fort Walton Beach, Florida 32547
    United States

    Active - Recruiting

  • The Orthopaedic Institute

    Gainesville, Florida 32607
    United States

    Site Not Available

  • The Orthopaedic Institute (CTR-US)

    Gainesville, Florida 32607
    United States

    Site Not Available

  • Central Florida Orthopaedic Surgery Associates, P.L

    Lakeland, Florida 74137
    United States

    Site Not Available

  • Central Florida Orthopaedic Surgery Associates, P.L (CTR-US)

    Lakeland, Florida 74137
    United States

    Site Not Available

  • Melbourne Hand Center (OCTR)

    Melbourne, Florida 32935
    United States

    Active - Recruiting

  • Miami Hand Center (NHVP)

    Miami, Florida 33133
    United States

    Site Not Available

  • The Orthopaedic Hand and Arm Center

    Miami Lakes, Florida 33014
    United States

    Active - Recruiting

  • The Orthopaedic Hand and Arm Center (CTR-US)

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • JMS Hand Associates

    Decatur, Illinois 62526
    United States

    Site Not Available

  • JMS Hand Associates (CTR-US)

    Decatur, Illinois 62526
    United States

    Site Not Available

  • Tri-State Orthopaedics

    Evansville, Indiana 47715
    United States

    Active - Recruiting

  • Tri-State Orthopaedics (CTR-US)

    Evansville, Indiana 47715
    United States

    Active - Recruiting

  • Bluegrass Orthopaedics

    Lexington, Kentucky 40509
    United States

    Active - Recruiting

  • Bluegrass Orthopaedics (CTR-US)

    Lexington, Kentucky 40509
    United States

    Active - Recruiting

  • Cape Cod Orthopaedics

    Hyannis, Massachusetts 02601-3825
    United States

    Active - Recruiting

  • Cape Cod Orthopaedics (CTR-US)

    Hyannis, Massachusetts 02601-3825
    United States

    Site Not Available

  • Excel Orthopaedic Specialists

    Woburn, Massachusetts 01801
    United States

    Active - Recruiting

  • Excel Orthopaedic Specialists (CTR-US)

    Woburn, Massachusetts 01801
    United States

    Site Not Available

  • Mendelson Orthopedic PC

    Troy, Michigan 48080
    United States

    Active - Recruiting

  • Mendelson Orthopedic PC (CTR-US)

    Troy, Michigan 48080
    United States

    Site Not Available

  • Twin Cities Orthopedics (OCTR)

    Edina, Minnesota 55435
    United States

    Active - Recruiting

  • Mississippi Sports Medicine& Orthopedic Center (ECTR)

    Jackson, Mississippi 39202
    United States

    Site Not Available

  • Orthopedic Asociates

    Saint Louis, Missouri 63131
    United States

    Active - Recruiting

  • Orthopedic Asociates (CTR-US)

    Saint Louis, Missouri 63131
    United States

    Site Not Available

  • Hand Center of Nevada

    Las Vegas, Nevada 89123
    United States

    Active - Recruiting

  • Hand Center of Nevada (CTR-US)

    Las Vegas, Nevada 89123
    United States

    Site Not Available

  • Dartmouth Hitchcock Clinic (ECTR)

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Mobility Bone and Joint Institute

    Salem, New Hampshire 03079
    United States

    Site Not Available

  • Mobility Bone and Joint Institute (CTR-US)

    Salem, New Hampshire 03079
    United States

    Site Not Available

  • New Mexico Orthopedics (CTR-US)

    Albuquerque, New Mexico 87110
    United States

    Site Not Available

  • Buffalo Surgery Center

    Amherst, New York 14226
    United States

    Active - Recruiting

  • Buffalo Surgery Center (CTR-US)

    Amherst, New York 14226
    United States

    Site Not Available

  • The Bone&Joint Surgery Clinic

    Raleigh, North Carolina 27609
    United States

    Active - Recruiting

  • The Bone&Joint Surgery Clinic (CTR-US)

    Raleigh, North Carolina 27609
    United States

    Active - Recruiting

  • Integris Health

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Integris Health (CTR-US)

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Northeast Oklahoma Hand and Upper Extremity Surgery

    Tulsa, Oklahoma 74137
    United States

    Site Not Available

  • Northeast Oklahoma Hand and Upper Extremity Surgery (CTR-US)

    Tulsa, Oklahoma 74137
    United States

    Site Not Available

  • The Center (ECTR)

    Bend, Oregon 97701
    United States

    Site Not Available

  • Slocum Research & Education Foundation (ECTR)

    Eugene, Oregon 97401
    United States

    Active - Recruiting

  • Meadville Medical Center (ECTR)

    Meadville, Pennsylvania 16335
    United States

    Site Not Available

  • University Orthopedics Center (OCTR)

    State College, Pennsylvania 16801
    United States

    Active - Recruiting

  • University Orthopedics, Inc.(OCTR)

    East Providence, Rhode Island 02914
    United States

    Active - Recruiting

  • Ortho SC

    Conway, South Carolina 29526
    United States

    Active - Recruiting

  • Ortho SC (CTR-US)

    Conway, South Carolina 29526
    United States

    Site Not Available

  • Prisma Health (ECTR)

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Sports Orthopedics & Spine

    Jackson, Tennessee 38305
    United States

    Active - Recruiting

  • Sports Orthopedics & Spine (CTR-US)

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • North Texas Hand Center

    Denton, Texas 76210
    United States

    Active - Recruiting

  • North Texas Hand Center (CTR-US)

    Denton, Texas 76210
    United States

    Site Not Available

  • North Texas Orthopedics and Spine Center

    Fort Worth, Texas 76244
    United States

    Active - Recruiting

  • North Texas Orthopedics and Spine Center (CTR-US)

    Fort Worth, Texas 76244
    United States

    Terminated

  • University of Wisconsin Health

    Madison, Wisconsin 53715
    United States

    Site Not Available

  • University of Wisconsin Health(CTR-US)

    Madison, Wisconsin 53715
    United States

    Site Not Available

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