Two-Year Follow-up of a Group-Sequential, Multicenter Randomized Controlled Trial of a Subacromial Balloon Spacer for Irreparable Rotator Cuff Tears of the Shoulder (START:REACTS)

Background: The best management of irreparable rotator cuff tears remains uncertain, with multiple new techniques introduced over the past 2 decades. Two options for treatment are arthroscopic debridement and biceps tenotomy, or the subacromial balloon spacer. Early trial results favored the former option, but the 2-year results have not yet been reported. Purpose: To report the 2-year follow-up outcomes of the START:REACTS trial, investigating the use of a subacromial balloon spacer for irreparable rotator cuff tears of the shoulder. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Eligible participants had an irreparable rotator cuff tear, intrusive symptoms requiring surgery, and previous unsuccessful nonoperative care. Participants were randomized 1:1 to debridement of the subacromial space with biceps tenotomy (debridement only) or the same procedure with the addition of the subacromial balloon spacer (debridement with device). The 12-month primary outcome was previously reported; this article presents the 24-month results. Linear regression models were used to analyze the 24-month data. Results: Recruitment stopped early at the preplanned interim analysis, with 117 participants in the trial. A total of 99 (85%) participants out of 117 were followed up to 24 months. At 24 months, a significant difference in the Oxford Shoulder Score was not found (95% CI, –7.9 to 0.4; P = .08). The Western Ontario Rotator Cuff score (mean difference, –10.1; 95% CI, –19.5 to −0.8; P = .04) and Patient Global Impression of Change (odds ratio, 0.4; 95% CI, 0.2 to 0.8; P = .015) were found to significantly favor debridement only. The EQ-5D-5L (mean difference, −0.009; 95% CI, −0.107 to 0.088; P = .85) and satisfaction scores (odds ratio, 0.6; 95% CI, 0.3 to −1.2; P = .14) were not significantly different. Complications were evenly matched between groups over 24 months. Conclusion: Participants continued to show better results in the debridement-only group compared with the group who had debridement with the InSpace balloon. Therefore, we do not recommend the subacromial balloon spacer for the treatment of irreparable rotator cuff tears.