Registry of the Patient Experience for Carpal Tunnel Release
MISSION
1 other identifier
observational
2,000
1 country
33
Brief Summary
Multi-center study to collect large scale, multidimensional real-world data on patients undergoing carpal tunnel release (CTR).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2024
Longer than P75 for all trials
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2023
CompletedFirst Posted
Study publicly available on registry
October 6, 2023
CompletedStudy Start
First participant enrolled
January 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
February 6, 2026
February 1, 2026
3.9 years
September 26, 2023
February 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS)
Scoring for the BCTQ- SSS ranges from 1 to 5, with higher scores indicating more severe symptoms, and is calculated as the mean of each response. The change in BCTQ-SSS score at the 24-month follow-up relative to baseline.
24 Months
Secondary Outcomes (5)
Boston Carpal Tunnel Questionnaire - Functional Status Scale (BCTQ-FSS)
24 Months
Numeric Pain Scale
24 Months
EuroQoL 5-Dimension 5-Level (EQ-5D-5L)
24 Months
Device and/or Procedure Related Adverse Events
24 Months
Global Satisfaction with Carpal Tunnel Release Procedure
24 Months
Other Outcomes (2)
Pain medication use through 24 months
24 Months
Additional surgical interventions through 24 months
24 Months
Study Arms (3)
Ultrasound Guided Carpal Tunnel Release (CTR-US)
Carpal Tunnel Release using CTR-US technique
Open Carpal Tunnel Release (OCTR)
Carpal Tunnel Release Using Open Carpal Tunnel Release (OCTR)
Endoscopic Carpal Tunnel Release (ECTR)
Carpal Tunnel Release Using Endoscopic Carpal Tunnel Release (ECTR)
Interventions
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.
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.
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.
Eligibility Criteria
Patients with Carpal Tunnel Syndrome meeting study eligibility criteria. Patients are invited to volunteer to participate at selected study sites.
You may qualify if:
- CTR-US: Confirmatory diagnostic testing with ultrasound (median nerve cross-sectional area ≥10 mm2 in the proximal carpal tunnel region)
- 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.
You may not qualify if:
- Patient meets any of the contraindications per Instruction For Use (IFU)
- Patient has other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from completing all registry requirements.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
The Orthopaedic Group P.C. (CTR-US)
Foley, Alabama, 36535, United States
Phoenix Hand (CTR-US)
Scottsdale, Arizona, 85260, United States
Orthopaedics Associates of Hartford (OCTR)
Glastonbury, Connecticut, 06033, United States
Aventura Hand Center (CTR-US)
Aventura, Florida, 33180, United States
Orthopaedic Associates (CTR-US)
Fort Walton Beach, Florida, 32547, United States
Central Florida Orthopaedic Surgery Associates, P.L (CTR-US)
Lakeland, Florida, 74137, United States
Melbourne Hand Center (OCTR)
Melbourne, Florida, 32935, United States
Miami Hand Center (NHVP)
Miami, Florida, 33133, United States
The Orthopaedic Hand and Arm Center (CTR-US)
Miami Lakes, Florida, 33014, United States
Tri-State Orthopaedics (CTR-US)
Evansville, Indiana, 47715, United States
Bluegrass Orthopaedics (CTR-US)
Lexington, Kentucky, 40509, United States
Cape Cod Orthopaedics (CTR-US)
Hyannis, Massachusetts, 02601-3825, United States
Excel Orthopaedic Specialists (CTR-US)
Woburn, Massachusetts, 01801, United States
Mendelson Orthopedic PC (CTR-US)
Troy, Michigan, 48080, United States
Twin Cities Orthopedics (OCTR)
Edina, Minnesota, 55435, United States
Mississippi Sports Medicine& Orthopedic Center (ECTR)
Jackson, Mississippi, 39202, United States
Orthopedic Asociates (CTR-US)
St Louis, Missouri, 63131, United States
Hand Center of Nevada (CTR-US)
Las Vegas, Nevada, 89123, United States
Dartmouth Hitchcock Clinic (ECTR)
Lebanon, New Hampshire, 03756, United States
Mobility Bone and Joint Institute (CTR-US)
Salem, New Hampshire, 03079, United States
New Mexico Orthopedics (CTR-US)
Albuquerque, New Mexico, 87110, United States
Buffalo Surgery Center (CTR-US)
Amherst, New York, 14226, United States
The Bone&Joint Surgery Clinic (CTR-US)
Raleigh, North Carolina, 27609, United States
The Center (ECTR)
Bend, Oregon, 97701, United States
Slocum Research & Education Foundation (ECTR)
Eugene, Oregon, 97401, United States
Meadville Medical Center (ECTR)
Meadville, Pennsylvania, 16335, United States
University Orthopedics Center (OCTR)
State College, Pennsylvania, 16801, United States
University Orthopedics, Inc.(OCTR)
East Providence, Rhode Island, 02914, United States
Ortho SC (CTR-US)
Conway, South Carolina, 29526, United States
Prisma Health (ECTR)
Greenville, South Carolina, 29615, United States
Sports Orthopedics & Spine (CTR-US)
Jackson, Tennessee, 38305, United States
North Texas Hand Center (CTR-US)
Denton, Texas, 76210, United States
North Texas Orthopedics and Spine Center (CTR-US)
Fort Worth, Texas, 76244, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Victor M Marwin, MD, MBA
Bluegrass Orthopaedics
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2023
First Posted
October 6, 2023
Study Start
January 26, 2024
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
February 6, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
This study is privately funded and IPD will not be available for use beyond the study Sponsor or the participating Investigational Sites.