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Active Not Recruiting
NCT06071468
Registry of the Patient Experience for Carpal Tunnel Release
Conditions: Carpal Tunnel Syndrome, CTS
Sex: All
Ages: 18 Years – N/A
Enrollment: 1424
Sponsor: Sonex Health, Inc.
Location: The Orthopaedic Group P.C. Foley Alabama
Summary
Multi-center study to collect large scale, multidimensional real-world data on patients undergoing carpal tunnel release (CTR).
Eligibility Criteria
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)\*:
1. CTR-US: Confirmatory diagnostic testing with ultrasound (median nerve cross-sectional area ≥10 mm2 in the proximal carpal tunnel region)
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:
1. Patient meets any of the contraindications per Instruction For Use (IFU)
2. Patient has other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from completing all registry requirements.
Source: ClinicalTrials.gov (NCT06071468). StuddyBuddy aggregates publicly available trial information.