Clinical Research Directory
Browse clinical research sites, groups, and studies.
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
1424
Start Date
2024-01-26
Completion Date
2027-12-31
Last Updated
2026-09-14
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.
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