Protocol of a Multicenter Prospective Trial of Office-Based Carpal Tunnel Release With Ultrasound Guidance (ROBUST).

Abstract

Background Carpal tunnel release (CTR) is a common surgical procedure for patients with severe or refractory carpal tunnel syndrome (CTS) symptoms. Historically, CTR procedures have been performed in a hospital or an ambulatory surgery center (ASC). However, due to advancements in techniques, greater patient demand, and concerns about growing healthcare costs, there is a distinct trend toward performing CTR procedures in an office-based setting. Several small studies with limited follow-up duration have demonstrated the feasibility of CTR with ultrasound guidance (CTR-US) when performed in an office-based setting. The objective of this study is to evaluate the safety and effectiveness of office-based CTR-US in a large cohort of patients (n=140) with symptomatic CTS followed for two years post-treatment. Design and methods ROBUST is a prospective multicenter observational study in which 140 subjects at up to 12 sites in the United States will be treated with CTR-US in an office-based setting. The primary endpoint of the study is the change in the Boston Carpal Tunnel Questionnaire Symptom Severity Scale score. Secondary endpoints include time to return to normal daily activities, time to return to work among employed subjects, change in the Boston Carpal Tunnel Questionnaire Functional Status Scale score, change in the Michigan Hand Questionnaire overall and domain scores, change in the Numeric Pain Scale score, change in the EuroQoL-5 Dimension 5-Level score, global satisfaction scores, and the incidence of device or procedure-related adverse events. The primary analysis of study endpoints will occur three months post-treatment. Patient follow-up in this study will continue for two years. Conclusions A central institutional review board approved the study protocol, and a data safety monitoring board will provide study oversight. The authors plan to report study results at medical conferences and in peer-reviewed medical journals. The outcomes of ROBUST will provide physicians, patients, and payors with important safety and effectiveness data regarding the clinical utility of CTR-US when performed in an office setting.