Protocol for a randomised controlled trial of Subacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS)

Abstract

IntroductionShoulder pain due to irreparable rotator cuff tears can cause substantial disability, but treatment options are limited. A balloon spacer is a relatively simple addition to a standard arthroscopic debridement procedure, but it is costly and there is no current randomised trial evidence to support its use. This trial will evaluate the clinical and cost-effectiveness of a subacromial balloon spacer for individuals undergoing arthroscopic debridement for irreparable rotator cuff tears.New surgical procedures can provide substantial benefit to patients. Good quality randomised controlled trials (RCTs) are needed, but trials in surgery are typically long and expensive, exposing patients to risk and the healthcare system to substantial costs. One way to improve the efficiency of trials is with an adaptive sample size. Such methods are well established in drug trials but have rarely, if ever, been used in surgical trials.Methods and analysisSubacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS) is a participant and assessor blinded, adaptive, multicentre RCT comparing arthroscopic debridement with the InSpace balloon (Stryker, USA) to arthroscopic debridement alone for people with a symptomatic irreparable rotator cuff tear. It uses a group sequential adaptive design where interim analyses are performed using all of the 3, 6 and 12-month data that are available at each time point. A maximum of 221 participants will be randomised (1:1 ratio), this will provide 90% power (at the 5% level) for a 6 point difference in the primary outcome; the Oxford Shoulder Score at 12 months. A substudy will use deltoid-active MRI scans in 56 participants to assess the function of the balloon. Analysis will be on an intention-to-treat basis and reported according to principles established in the Consolidated Standards of Reporting Trials statement.Ethics and disseminationNRES number 18/WM/0025. The results will be disseminated via peer-reviewed publications, presentations at conferences, lay summaries and social media.Trial registration numberISRCTN17825590

How have researchers defined and used the concept of ‘efficiency’ in the context of trials? A review of existing literature and a proposed conceptual framework

“…The majority of the studies proposed improving trial efficiency by employing innovative trial designs, such as adaptive designs (33)(34)(35)(36)(37)(38)(39)(40)(41), master protocol trial designs(42) such as basket trials (32,43) and platform trials (44,45), sequential trial designs (8,46), clusters designs (47)(48)(49), factorial trials(28, 50) and registry-based trials (51). The primary rationale for proposing these novel designs to improve efficiency was to lower cost (9,32) and shorten the time (50) required in the traditional trials.…”

Treatment Options for Massive Irreparable Rotator Cuff Tears

“…There is a clear need for randomized controlled trials to compare subacromial balloon implantation with other methods of treatment for massive irreparable tears. Currently, a randomized adaptive clinical trial in the UK comparing the balloon spacer with debridement (START: REACTS trial) is underway, and a large multi-center randomized controlled trial comparing the balloon spacer to partial repair was recently completed in the USA, though results have yet to be published [46,47]. These trials will also ideally clarify specific indications for balloon spacers, which may include patients without arthritis who have intact passive range of motion and an intact subscapularis [48].…”

Clinical Trials Impacted by the COVID-19 Pandemic: Adaptive Designs to the Rescue?

“…Our second example is the Subacromial spacers for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS) (ISRCTN16912075), an adaptive design multicenter randomized controlled trial conducted in the United Kingdom comparing arthroscopic debridement with the InSpace balloon (Stryker, USA) to arthroscopic debridement alone for people with a symptomatic irreparable rotator cuff tear (Metcalfe et al 2020). Recruitment to the trial started in February 2018, with a planned total sample size of 221 with the potential to stop the study for efficacy or futility at a number of interim analyses.…”