Registry of the Patient Experience for Carpal Tunnel Release
NCT ID: NCT06071468
Last Updated: 2026-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
2000 participants
OBSERVATIONAL
2024-01-26
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Ultrasound Guided Carpal Tunnel Release (CTR-US)
Carpal Tunnel Release using CTR-US technique
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.
Open Carpal Tunnel Release (OCTR)
Carpal Tunnel Release Using Open Carpal Tunnel Release (OCTR)
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.
Endoscopic Carpal Tunnel Release (ECTR)
Carpal Tunnel Release Using Endoscopic Carpal Tunnel Release (ECTR)
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. ECTR or OCTR: Confirmatory electrodiagnostic testing 6. Prior failure of one or more nonsurgical treatment options (e.g., physical activity modification, bracing, splinting, corticosteroid injection) in the target hand(s) 7. Patient agrees to complete follow-up questionnaires over a 24-month period 8. Patient has a valid smart phone number and/or email address to receive and answer follow-up questionnaires
Note: An asterisk (\*) denotes that this criterion must be applied to the target hand for unilateral CTR procedures, or to both hands for simultaneous bilateral CTR procedures.
Exclusion Criteria
2. Patient has other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from completing all registry requirements.
18 Years
ALL
No
Sponsors
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Sonex Health, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Victor M Marwin, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
Bluegrass Orthopaedics
Locations
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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
Countries
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Other Identifiers
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90154-TP
Identifier Type: -
Identifier Source: org_study_id
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