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Office-based Unilateral versus Simultaneous Bilateral Carpal Tunnel Release with Ultrasound Guidance: 1-year Results from the ROBUST Trial
Ashley L Pistorio, MD, MS
1; Victor M Marwin, MD, MBA
2; Paul D Paterson, MD
3; Randall D Alexander, MD
4; Johnny T Nelson, MD
5; Larry E Miller, PhD
61Kirk Kerkorian School of Medicine at UNLV, Las Vegas, NV; 2Bluegrass Orthopaedics, Lexington, KY; 3Vero Beach Orthopaedics, Vero Beach, FL; 4Georgia Hand, Shoulder, & Elbow, Atlanta, GA; 5The Bone and Joint Surgery Clinic, Raleigh, NC; 6Miller Scientific, Johnson City, TN
Introduction: Carpal tunnel release with ultrasound guidance (CTR-US) is a promising technique for carpal tunnel syndrome treatment in office settings. The comparative performance of unilateral (UL) versus simultaneous bilateral (SBL) office-based CTR-US remains incompletely characterized.
Materials & Methods: We conducted a prospective multicenter trial of patients undergoing in-office CTR-US. Outcome measures included resumption of normal activities, return to work, Boston Carpal Tunnel Questionnaire (BCTQ) Symptom Severity Scale (SSS) and Functional Status Scale (FSS), Michigan Hand Questionnaire (MHQ), numeric pain scale (0-10), EuroQol 5-Dimension 5-Level (EQ-5D-5L), patient satisfaction, and complications. A linear mixed model analyzed longitudinal outcomes through 1 year, with least-squares mean (LSM) differences comparing UL and SBL groups.
Results: The trial included 149 patients (mean age 58 years; 52% female) treated with CTR-US (mean incision length=5 mm) at 7 centers, with 72 receiving UL and 77 receiving SBL (226 hands). Procedures were performed in-office using wide-awake local anesthesia without a tourniquet; none were discontinued or converted to open repair. Comparing UL to SBL, the median time to resume normal activities was 2 days in each group, and time to return to work was 3 and 4 days, respectively. At 1 year, both groups demonstrated statistically significant and clinically important improvements across all outcomes (all p<0.001). BCTQ-SSS improved from 3.1 to 1.2 in UL and 3.0 to 1.2 in SBL (LSM difference=0.0; p=0.88). BCTQ-FSS improved from 2.2 to 1.2 for UL and 2.3 to 1.2 for SBL (LSM difference=0.0; p=0.92). Global MHQ scores increased from 53 to 91 for UL and 56 to 92 for SBL (LSM difference=-1; p=0.63). Mean pain scores decreased from 4.8 to 0.6 for UL and 4.1 to 0.5 for SBL (LSM difference=0.1; p=0.82). EQ-5D-5L index scores improved from 0.77 to 0.88 with UL and 0.78 to 0.92 with SBL, with a statistically significant, minor difference favoring SBL procedures (LSM=-0.05; p=0.01). Patient satisfaction was high in both groups (94% UL vs. 95% SBL; p>0.99) One (0.4%) adverse event occurred; a nerve contusion with a small epineurial injury successfully treated with neurolysis and nerve wrap resulting in full functional recovery. There were no infections or revisions for persistent or recurrent carpal tunnel syndrome symptoms.
Conclusions: Office-based CTR-US demonstrated comparable safety and efficacy for UL and SBL procedures, with sustained clinically important improvements at 1 year. In-office CTR-US safely facilitates same-day treatment of unilateral or bilateral carpal tunnel syndrome, potentially optimizing patient care efficiency and clinical workflow.
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