The START:REACTS Trial: Have 30,000 People Had The Wrong Shoulder Operation?

Description

This transcript details a presentation given at a conference concerning a plenary session run by the BOA research committee, hosted by Hamish Simpson. The session highlights ongoing research initiatives and encourages participation from attendees. Among the topics discussed are the BOA OR UK research fellowships and efforts to connect specialist societies and their research leads, aiming to improve recognition of industry-funded trauma orthopedic research.



The session features several talks, including a notable presentation by Andrew Metcalfe on a clinical trial called Start Reacts. The trial investigates the effectiveness of the InSpace subacromial balloon, which is designed for patients with irreparable rotator cuff tears. Metcalfe explains the trial's design, methodology, and results, emphasizing that despite initial anticipations, the standard debridement procedure outperformed the procedure involving the balloon in terms of patient outcomes measured with the Oxford Shoulder Score.



There are insights into trial operations, such as blinding methods used to maintain objectivity and the challenge posed by the COVID-19 pandemic, which unexpectedly truncated the trial. The results indicated a significant mean difference favoring the debridement-only approach, with subgroup analyses revealing varying effects based on patient sex.



The presentation concludes with an emphasis on the necessity of clinical trials when introducing new medical devices and techniques, supporting calls for comprehensive data capture in clinical practice, and hinting at forthcoming two-year follow-up results.

DOI: 10.1302/3114-230290

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