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Multi-center study to collect large scale, multidimensional real-world data on patients undergoing carpal tunnel release (CTR).
Multicenter prospective Registry of patients with symptomatic carpal tunnel syndrome (CTS) treated (unilateral or simultaneous bilateral) by Ultrasound guided CTR (CTR-US), Endoscopic CTR (ECTR), or Open CTR (OCTR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound Guided Carpal Tunnel Release (CTR-US) | Carpal Tunnel Release using CTR-US technique |
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| Open Carpal Tunnel Release (OCTR) | Carpal Tunnel Release Using Open Carpal Tunnel Release (OCTR) |
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| Endoscopic Carpal Tunnel Release (ECTR) | Carpal Tunnel Release Using Endoscopic Carpal Tunnel Release (ECTR) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UltraGuideCTR (Device) with Ultrasound Guided Carpal Tunnel Release (CTR-US) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Boston Carpal Tunnel Questionnaire - Functional Status Scale (BCTQ-FSS) | 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. | 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain medication use through 24 months | Post-index procedure use of pain medication by type (prescription [Tramadol (Ultram) or tapentadol (Nucynta) vs other prescribed opioids / narcotics], non-prescription) | 24 Months |
| Additional surgical interventions through 24 months |
Inclusion Criteria 1. ≥18 years of age 2. Clinical diagnosis of unilateral or bilateral CTS 3. A clinical decision has been made to perform CTR on one or both hands 4. CTS-6 score ≥12 in the target hand(s)* 5. Confirmatory diagnostic testing in the target hand(s)*:
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:
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Patients with Carpal Tunnel Syndrome meeting study eligibility criteria. Patients are invited to volunteer to participate at selected study sites.
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| Name | Affiliation | Role |
|---|---|---|
| Victor M Marwin, MD, MBA | Bluegrass Orthopaedics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Orthopaedic Group P.C. (CTR-US) | Foley | Alabama | 36535 | United States | ||
| Phoenix Hand (CTR-US) |
This study is privately funded and IPD will not be available for use beyond the study Sponsor or the participating Investigational Sites.
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| Endocscopic CTR | Procedure | Endoscopic CTR makes one or two short incisions to introduce instruments for visualizing. The key procedural steps involved in Endoscopic CTR are listed below.
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| Open CTR | Procedure | OCTR is the most commonly used CTR technique in the United States.The key procedural steps involved in OCTR are listed below.
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| Numeric Pain Scale |
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. |
| 24 Months |
| EuroQoL 5-Dimension 5-Level (EQ-5D-5L) | 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. | 24 Months |
| Device and/or Procedure Related Adverse Events | Incidence of device- or procedure-related AEs within 24 months of treatment. | 24 Months |
| Global Satisfaction with Carpal Tunnel Release Procedure | 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. | 24 Months |
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| 24 Months |
| 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 |
| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
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