2,000
Participants
Start Date
January 26, 2024
Primary Completion Date
December 31, 2027
Study Completion Date
December 31, 2027
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."
ACTIVE_NOT_RECRUITING
Buffalo Surgery Center (CTR-US), Amherst
ACTIVE_NOT_RECRUITING
Meadville Medical Center (ECTR), Meadville
ACTIVE_NOT_RECRUITING
University Orthopedics Center (OCTR), State College
RECRUITING
The Bone&Joint Surgery Clinic (CTR-US), Raleigh
ACTIVE_NOT_RECRUITING
Ortho SC (CTR-US), Conway
ACTIVE_NOT_RECRUITING
Prisma Health (ECTR), Greenville
RECRUITING
Orthopaedic Associates (CTR-US), Fort Walton Beach
WITHDRAWN
The Orthopaedic Institute (CTR-US), Gainesville
ACTIVE_NOT_RECRUITING
Melbourne Hand Center (OCTR), Melbourne
ACTIVE_NOT_RECRUITING
The Orthopaedic Hand and Arm Center (CTR-US), Miami Lakes
ACTIVE_NOT_RECRUITING
Miami Hand Center (NHVP), Miami
ACTIVE_NOT_RECRUITING
Aventura Hand Center (CTR-US), Aventura
ACTIVE_NOT_RECRUITING
The Orthopaedic Group P.C. (CTR-US), Foley
ACTIVE_NOT_RECRUITING
Sports Orthopedics & Spine (CTR-US), Jackson
ACTIVE_NOT_RECRUITING
Mississippi Sports Medicine& Orthopedic Center (ECTR), Jackson
RECRUITING
Bluegrass Orthopaedics (CTR-US), Lexington
RECRUITING
Tri-State Orthopaedics (CTR-US), Evansville
ACTIVE_NOT_RECRUITING
Mendelson Orthopedic PC (CTR-US), Troy
ACTIVE_NOT_RECRUITING
Twin Cities Orthopedics (OCTR), Edina
WITHDRAWN
JMS Hand Associates (CTR-US), Decatur
ACTIVE_NOT_RECRUITING
Orthopedic Asociates (CTR-US), St Louis
WITHDRAWN
Integris Health (CTR-US), Oklahoma City
ACTIVE_NOT_RECRUITING
Central Florida Orthopaedic Surgery Associates, P.L (CTR-US), Lakeland
WITHDRAWN
Northeast Oklahoma Hand and Upper Extremity Surgery (CTR-US), Tulsa
ACTIVE_NOT_RECRUITING
North Texas Hand Center (CTR-US), Denton
TERMINATED
North Texas Orthopedics and Spine Center (CTR-US), Fort Worth
ACTIVE_NOT_RECRUITING
Phoenix Hand (CTR-US), Scottsdale
ACTIVE_NOT_RECRUITING
New Mexico Orthopedics (CTR-US), Albuquerque
ACTIVE_NOT_RECRUITING
Hand Center of Nevada (CTR-US), Las Vegas
ACTIVE_NOT_RECRUITING
Slocum Research & Education Foundation (ECTR), Eugene
ACTIVE_NOT_RECRUITING
The Center (ECTR), Bend
ACTIVE_NOT_RECRUITING
Orthopaedics Associates of Hartford (OCTR), Glastonbury
ACTIVE_NOT_RECRUITING
Cape Cod Orthopaedics (CTR-US), Hyannis
ACTIVE_NOT_RECRUITING
Excel Orthopaedic Specialists (CTR-US), Woburn
ACTIVE_NOT_RECRUITING
Dartmouth Hitchcock Clinic (ECTR), Lebanon
ACTIVE_NOT_RECRUITING
Mobility Bone and Joint Institute (CTR-US), Salem
ACTIVE_NOT_RECRUITING
University Orthopedics, Inc.(OCTR), East Providence
Sonex Health, Inc.
INDUSTRY