Post-Market Registry of the Patient Experience When Using UltraGuideCTR for Carpal Tunnel Release
- Conditions
- Carpal Tunnel SyndromeCTS
- Interventions
- Device: UltraGuideCTR (Device) with Ultrasound Guided Carpal Tunnel Release (CTR-US)Procedure: Open CTRProcedure: Endocscopic CTR
- Registration Number
- NCT06071468
- Lead Sponsor
- Sonex Health, Inc.
- Brief Summary
Multicenter prospective registry of patients with symptomatic Carpal Tunnel Syndrome treated with Ultrasound Guided Carpal Tunnel Release (CTR-US).
- Detailed Description
Multicenter prospective registry of patients with symptomatic Carpal Tunnel Syndrome treated with Ultrasound Guided Carpal Tunnel Release (CTR-US) to collect large scale, multidimensional real-world data.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2000
Not provided
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ultrasound Guided Carpal Tunnel Release (CTR-US) UltraGuideCTR (Device) with Ultrasound Guided Carpal Tunnel Release (CTR-US) Carpal Tunnel Release using CTR-US technique Open Carpal Tunnel Release (OCTR) Open CTR Carpal Tunnel Release Using Open Carpal Tunnel Release (OCTR) Endoscopic Carpal Tunnel Release (ECTR) Endocscopic CTR Carpal Tunnel Release Using Endoscopic Carpal Tunnel Release (ECTR)
- Primary Outcome Measures
Name Time Method Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS) 24 Months 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.
- Secondary Outcome Measures
Name Time Method Boston Carpal Tunnel Questionnaire - Functional Status Scale (BCTQ-FSS) 24 Months Scoring for the BCTQ-FSS ranges from 1 to 5, with higher scores indicating more functional limitation, and is calculated as the mean of each response. The change in BCTQ-FSS score at the 24-month follow-up relative to baseline.
Numeric Pain Scale 24 Months Subjects will be asked to rate their wrist pain severity on a scale of 0 to 10, where 0 represents "no pain" and 10 represents "worst possible pain". The change in Numeric Pain Scale score at the 24-month follow-up relative to baseline.
EuroQoL 5-Dimension 5-Level (EQ-5D-5L) 24 Months The EQ-5D-5L measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking consisting of: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. The change in EQ-5D-5L score at the 24-month follow-up relative to baseline.
Device and/or Procedure Related Adverse Events 24 Months Incidence of device- or procedure-related AEs within 24 months of treatment.
Global Satisfaction with Carpal Tunnel Release Procedure 24 Months Subjects will be asked to rate their satisfaction with the carpal tunnel release procedure and how likely they are to recommend their carpal tunnel release procedure to a friend or colleague on a scale from 0-10 with 0 being not at all likely and 10 being extremely likely. Satisfaction will be reported with the following options: Very Satisfied, Satisfied, Neither Satisfied or dissatisfied, Dissatisfied or Very dissatisfied.
Trial Locations
- Locations (37)
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
The Orthopaedic Institute (CTR-US)
🇺🇸Gainesville, Florida, United States
Central Florida Orthopaedic Surgery Associates, P.L (CTR-US)
🇺🇸Lakeland, Florida, United States
Melbourne Hand Center (OCTR)
🇺🇸Melbourne, Florida, United States
The Orthopaedic Hand and Arm Center (CTR-US)
🇺🇸Miami Lakes, Florida, United States
Miami Hand Center (NHVP)
🇺🇸Miami, Florida, United States
JMS Hand Associates (CTR-US)
🇺🇸Decatur, Illinois, 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)
🇺🇸Saint 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
Integris Health (CTR-US)
🇺🇸Oklahoma City, Oklahoma, United States
Northeast Oklahoma Hand and Upper Extremity Surgery (CTR-US)
🇺🇸Tulsa, Oklahoma, 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