MISSION: Post-Market Registry of the Patient Experience When Using UltraGuideCTR for Carpal Tunnel Release
Study Details
Study Description
Brief Summary
Multicenter prospective registry of patients with symptomatic Carpal Tunnel Syndrome treated with Ultrasound Guided Carpal Tunnel Release (CTR-US).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| CTR-US Ultrasound Guided Carpal Tunnel Release (CTR-US) |
Device: 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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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
- Time to Return To Normal Daily Activities (RTA) [24 Months]
Time to return to normal daily activities will be defined as the number of days between treatment and the time the subject reports returning to normal daily activities, irrespective of work status.
- Time to Return To Work Among Employed Subjects (RTW) [24 Months]
Time to return to work will be defined as the number of days between treatment and the time the subject reports returning to work in any capacity.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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≥18 years of age
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Clinical diagnosis of unilateral or bilateral CTS
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A clinical decision has been made to perform CTR-US using UltraGuideCTR on one or both hands
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CTS-6 score >12 in the target hand(s)
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Confirmatory diagnostic testing with ultrasound (median nerve cross-sectional area ≥10 mm2 in the proximal carpal tunnel region)
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Prior failure of one or more nonsurgical treatment options (e.g., physical activity modification, bracing, splinting, corticosteroid injection) in the target hand(s)
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Patient agrees to complete follow-up questionnaires over a 24-month period.
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Patient has a valid smart phone number and/or email address to receive and answer follow-up questionnaires
Exclusion Criteria:
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Patient meets any of the contraindications per Instruction For Use (IFU)
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Patient has other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from completing all registry requirements.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bluegrass Orthopaedics | Lexington | Kentucky | United States | 40509 |
Sponsors and Collaborators
- Sonex Health, Inc.
Investigators
- Principal Investigator: Victor M Marwin, MD, MBA, Bluegrass Orthopaedics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 90154-TP