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ACTIVE NOT RECRUITING
NCT06071468

Registry of the Patient Experience for Carpal Tunnel Release

Sponsor: Sonex Health, Inc.

View on ClinicalTrials.gov

Summary

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

Official title: Registry of the Patient Experience for Carpal Tunnel Release (MISSION)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

2000

Start Date

2024-01-26

Completion Date

2027-12-31

Last Updated

2026-02-06

Healthy Volunteers

Not specified

Interventions

DEVICE

UltraGuideCTR (Device) with Ultrasound Guided Carpal Tunnel Release (CTR-US)

The UltraGuideCTR is a commercially available medical device specifically developed to facilitate CTR-US. The device is a single-use, hand-held device that is inserted into the carpal tunnel through a small (typically \< 5 mm) wrist incision using continuous US guidance. The working tip of the UltraGuideCTR consists of two inflatable balloons that border a centrally located, retractable retrograde cutting knife. When inflated with sterile saline, the balloons increase the diameter of the tip from 4 mm to 8 mm. After the tip is positioned within the transverse safe zone of the carpal tunnel, the balloons are inflated to create space in the carpal tunnel, the blade is activated, and the TCL is transected in a retrograde manner. Following TCL transection, the blade is recessed, the balloons deflated, and the device is removed. The TCL is probed to ensure a complete release. The entire procedure is performed using US guidance.

PROCEDURE

Endocscopic CTR

Endoscopic CTR makes one or two short incisions to introduce instruments for visualizing. The key procedural steps involved in Endoscopic CTR are listed below. 1. Following the delivery of anesthesia, the surgeon makes a small wrist incision (usually less than 1.5 cm), with or without a small palmar incision (usually less than 1.5 cm, depending on whether they are using a single portal or double portal technique, respectively. 2. A series of dilators and raspers are used to create space in the carpal tunnel and clear synovial tissue from the undersurface fo the TCL. 3. A camera attached to a narrow tube (endoscope) is inserted into the carpal tunnel. 4. The transverse carpal ligament (which forms the roof of the carpal tunnel) is identified. 5. Using specialized cutting instruments and endoscopic guidance, the surgeon transects the TCL. 6. Endoscopic visualization and/or probing are used to confirm a complete release. 7. The wound(s) is/are typically closed with sutures.

PROCEDURE

Open CTR

OCTR is the most commonly used CTR technique in the United States.The key procedural steps involved in OCTR are listed below. 1. Following the delivery of anesthesia, an incision is made in the palm directly over the carpal tunnel. 2. The surgeon cuts through the palmar fascia to identify the TCL. 3. The surgeon transects the TCL with a scalpel and/or similar cutting instruments. 4. The surgeon inspects the carpal tunnel to ensure proper decompression. 5. The wound is closed with sutures.

Locations (33)

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

Foley, Alabama, United States

Phoenix Hand (CTR-US)

Scottsdale, Arizona, United States

Orthopaedics Associates of Hartford (OCTR)

Glastonbury, Connecticut, United States

Aventura Hand Center (CTR-US)

Aventura, Florida, United States

Orthopaedic Associates (CTR-US)

Fort Walton Beach, Florida, United States

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

Lakeland, Florida, United States

Melbourne Hand Center (OCTR)

Melbourne, Florida, United States

Miami Hand Center (NHVP)

Miami, Florida, United States

The Orthopaedic Hand and Arm Center (CTR-US)

Miami Lakes, Florida, United States

Tri-State Orthopaedics (CTR-US)

Evansville, Indiana, United States

Bluegrass Orthopaedics (CTR-US)

Lexington, Kentucky, United States

Cape Cod Orthopaedics (CTR-US)

Hyannis, Massachusetts, United States

Excel Orthopaedic Specialists (CTR-US)

Woburn, Massachusetts, United States

Mendelson Orthopedic PC (CTR-US)

Troy, Michigan, United States

Twin Cities Orthopedics (OCTR)

Edina, Minnesota, United States

Mississippi Sports Medicine& Orthopedic Center (ECTR)

Jackson, Mississippi, United States

Orthopedic Asociates (CTR-US)

St Louis, Missouri, United States

Hand Center of Nevada (CTR-US)

Las Vegas, Nevada, United States

Dartmouth Hitchcock Clinic (ECTR)

Lebanon, New Hampshire, United States

Mobility Bone and Joint Institute (CTR-US)

Salem, New Hampshire, United States

New Mexico Orthopedics (CTR-US)

Albuquerque, New Mexico, United States

Buffalo Surgery Center (CTR-US)

Amherst, New York, United States

The Bone&Joint Surgery Clinic (CTR-US)

Raleigh, North Carolina, United States

The Center (ECTR)

Bend, Oregon, United States

Slocum Research & Education Foundation (ECTR)

Eugene, Oregon, United States

Meadville Medical Center (ECTR)

Meadville, Pennsylvania, United States

University Orthopedics Center (OCTR)

State College, Pennsylvania, United States

University Orthopedics, Inc.(OCTR)

East Providence, Rhode Island, United States

Ortho SC (CTR-US)

Conway, South Carolina, United States

Prisma Health (ECTR)

Greenville, South Carolina, United States

Sports Orthopedics & Spine (CTR-US)

Jackson, Tennessee, United States

North Texas Hand Center (CTR-US)

Denton, Texas, United States

North Texas Orthopedics and Spine Center (CTR-US)

Fort Worth, Texas, United States