Final 2-year Results From the ROBUST Trial of Office-based Ultrasound-guided Carpal Tunnel Release.

BACKGROUND: There has been a growing interest in transitioning carpal tunnel release procedures to the office setting. We report the final 2-year safety and effectiveness outcomes of office-based ultrasound-guided carpal tunnel release (UGCTR). METHODS: ROBUST was a prospective multicenter observational study of adults with idiopathic carpal tunnel syndrome who underwent office-based UGCTR. Main outcomes included time to return to normal activities and work, Boston Carpal Tunnel Questionnaire Symptom Severity Scale and Functional Status Scale, Michigan Hand Questionnaire, pain severity (0-10 scale), health-related quality of life measured using the EuroQoL 5-Dimension 5-Level index, overall patient satisfaction, and complications. A subgroup analysis compared outcomes of unilateral and simultaneous bilateral procedures. RESULTS: The trial enrolled 149 patients across 7 sites who underwent office-based UGCTR under wide-awake local anesthesia no-tourniquet (72 unilateral; 77 simultaneous bilateral). Median time to return to normal activities and work was 2 and 4 days, respectively. Follow-up compliance was 92.6% at 2 years. All patient-reported outcomes improved significantly from baseline (P < 0.001). At 2 years, mean scores were 1.25 for Boston Carpal Tunnel Questionnaire Symptom Severity Scale, 1.19 for Boston Carpal Tunnel Questionnaire Functional Status Scale, 88 for Michigan Hand Questionnaire, 0.5 for pain severity, and 0.91 for the EuroQoL 5-Dimension 5-Level index. Overall satisfaction was 95.7% at the 2-year follow-up. One complication (0.4% per hand) occurred, and no revisions for persistent/recurrent symptoms were performed through 2 years. Results were comparable between unilateral and simultaneous bilateral procedures across all outcomes (all P > 0.1). CONCLUSIONS: Office-based UGCTR safely provided durable symptom relief, functional improvement, and high patient satisfaction during the 2-year follow-up, with comparable outcomes between unilateral and simultaneous bilateral procedures.