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Registry of the Patient Experience for Carpal Tunnel Release
Sponsor: Sonex Health, Inc.
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
Conditions
Interventions
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.
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.
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