Subacromial Balloon Spacer for Irreparable Rotator Cuff Tears .
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Subacromial balloon spacer for irreparable rotator cuff tears of the shoulder (START:REACTS): a group-sequential, double-blind, multicentre randomised controlled trial
Lancet. 2022 Apr 21;S0140-6736(22)00652-3.117 patients with irreparable rotator cuff tears were randomized to receive debridment plus the insertion of a subacromial balloon spacer (n=56) or debridement only (n=61). The primary outcome of interest was the Oxford Shoulder Score (OSS) at 12 months. Secondary outcomes of interest included the Constant Shoulder Score, range of motion in flexion and abduction, the Western Ontario Rotator Cuff (WORC) index, the EuroQol EQ-5D-5L, change in symptoms, Participant Global Impression of Change (PGIC), resource use, and adverse events. Results revealed significantly better OSS scores in the debridement only group at 3, 6 and 12 months. Objective outcome measures were limited by missing data due to COVID-19 restrictions. Constant scores were also in favour of the debridement only group at 12 months. There were no differences in safety events between the two groups. The study was stopped early due to futility.
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