Study to compare the safety and effectiveness of carpal tunnel release with ultrasound guidance (CTR-US) vs. mini-open carpal tunnel release (mOCTR) in patients with symptomatic carpal tunnel syndrome (CTS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
122
Carpal Tunnel Release with Ultrasound Guidance using UltraGuideCTR device
Mini Open Carpal Tunnel Release
Sierra Orthopedic Institute
Sonora, California, United States
Orthopedic Associates
Fort Walton Beach, Florida, United States
Tri-State Orthopaedics
Evansville, Indiana, United States
Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) Change
The Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) is a Carpal Tunnel Syndrome specific questionnaire that has been shown to be highly reproducible, internally consistent, valid, and responsive to clinical change in Carpal Tunnel Syndrome (CTS) and subject status post-carpal tunnel release (CTR). The BCTQ consists of 11 symptom severity questions (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 mean change scores in BCTQ-SSS from baseline to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased symptom severity and positive change scores indicate increased symptom severity.
Time frame: 3 Month Follow-Up
Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) Change
The Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) additionally consists of 8 functional status questions. 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 mean change scores in BCTQ-FSS from baseline to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased functional limitation and positive change scores indicate increased functional limitation.
Time frame: 3 Month Follow-Up
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Indiana Hand to Shoulder
Indianapolis, Indiana, United States
Kansas Orthopaedic Center
Wichita, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Twin Cities Orthopedics
Plymouth, Minnesota, United States
University of Mississippi
Jackson, Mississippi, United States
Midwest Orthopedic Group
Farmington, Missouri, United States
Sano Orthopedics
Lee's Summit, Missouri, United States
...and 2 more locations