Surgery versus Conservative OsteOarthritis of Thumb Trial (SCOOTT)An RCT to determine clinical and cost effectiveness of treating arthritis of the base of the thumb, with or without surgery, and to determine the clinical and cost effectiveness of trapeziectomy versus base of thumb joint replacement.

RESEARCH QUESTIONS In line with the brief, the aim of this multi-centre, randomised three-arm trial is to answer two important questions: 1) Is surgery [Trapeziectomy or Carpometacarpal Joint Replacement (CMCJR)] superior to enhanced non-surgical management? 2) Is CMCJR non-inferior to trapeziectomy? BACKGROUND Basal thumb osteoarthritis (BTOA) is common and causes significant morbidity. Symptoms include thumb pain, tenderness and stiffness, which negatively impact activities of daily living and quality of life. A variety of non-surgical and surgical treatments are available. However, despite National Institute for Health and Care Excellence (NICE) guidelines advocating a stepped care approach for BTOA, our research suggests only 21-45% of patients referred to secondary care receive any non-surgical management at all, and even that is variable. We co produced an enhanced package of non-surgical treatment (the ’ENGAGE’ package), which offers patients a programme of personalised, psychologically informed treatments, supported by evidence based educational materials, and delivered by trained hand therapists. Trapeziectomy is currently the established surgical treatment undertaken, but CMCJR is increasingly offered to patients in the NHS, despite lack of high quality evidence for currently used treatment options. AIMS Primary: to quantify and draw inferences on observed differences in pain, as measured by the AUSCAN hand pain index between the three treatment groups at 12 months post-randomisation. Secondary:to investigate the comparative cost-effectiveness of the interventions at 12 months. To undertake qualitative analysis to investigate patients’ and clinicians’ experiences and the acceptability of the three treatment interventions. TARGET POPULATION Adults with symptomatic BTOA who may benefit from surgery according to the treating clinician. METHODS 656 consenting adult patients referred to secondary care will be randomised on a 3:3:2 basis to receive trapeziectomy, CMCJR or Enhanced Non-surGical manAGEment (ENGAGE). A pilot phase will assess recruitment rate and follow-up across eight NHS sites. A further minimum 12 sites will be set up for the main trial. TIMELINES FOR DELIVERY Trial duration 54 months: 0-6m study set up,7-18m internal pilot, 19-30m main trial recruitment, 31-48m follow-up, 49-54m analysis, report, dissemination. ANTICIPATED IMPACT/DISSEMINATION Guide best clinical practice and inform national guidelines via our professional networks. Write articles for peer-reviewed publication, and present our findings at national and international conferences; share videos/infographics on social media for patients and the global online hand community.