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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

1424

Start Date

2024-01-26

Completion Date

2027-12-31

Last Updated

2026-09-14

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.

Foley, Alabama, United States

Phoenix Hand

Scottsdale, Arizona, United States

Orthopaedics Associates of Hartford

Glastonbury, Connecticut, United States

Aventura Hand Center

Aventura, Florida, United States

Orthopaedic Associates

Fort Walton Beach, Florida, United States

Lakeland Regional Health

Lakeland, Florida, United States

Melbourne Hand Center

Melbourne, Florida, United States

Miami Hand Center

Miami, Florida, United States

The Orthopaedic Hand and Arm Center

Miami Lakes, Florida, United States

Vero Orthopaedics

Vero Beach, Florida, United States

Tri-State Orthopaedics

Evansville, Indiana, United States

Cape Cod Orthopaedics

Hyannis, Massachusetts, United States

Excel Orthopaedic Specialists

Woburn, Massachusetts, United States

Mendelson Orthopedic PC

Troy, Michigan, United States

Twin Cities Orthopedics

Edina, Minnesota, United States

Mississippi Sports Medicine& Orthopedic Center

Jackson, Mississippi, United States

Orthopedic Asociates

St Louis, Missouri, United States

Hand Center of Nevada

Las Vegas, Nevada, United States

Dartmouth Hitchcock Clinic

Lebanon, New Hampshire, United States

Mobility Bone and Joint Institute

Salem, New Hampshire, United States

New Mexico Orthopedics

Albuquerque, New Mexico, United States

Buffalo Surgery Center

Amherst, New York, United States

The Bone&Joint Surgery Clinic

Raleigh, North Carolina, United States

The Center

Bend, Oregon, United States

Slocum Research & Education Foundation

Eugene, Oregon, United States

Meadville Medical Center

Meadville, Pennsylvania, United States

University Orthopedics Center

State College, Pennsylvania, United States

University Orthopedics, Inc.

East Providence, Rhode Island, United States

OrthoSC

Conway, South Carolina, United States

Prisma Health

Greenville, South Carolina, United States

Sports Orthopedics & Spine

Jackson, Tennessee, United States

North Texas Hand Center

Denton, Texas, United States

North Texas Orthopedics and Spine Center

Fort Worth, Texas, United States