Two-Year Follow-up of a RCT on Subacromial Balloon Spacer for Irreparable Rotator Cuff Tears .
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).
Am J Sports Med . 2025 May;53(6):1291-1298.One hundred seventeen patients with irreparable rotator cuff tears were randomized to receive either arthroscopic debridement with biceps tenotomy (n=61) or the same procedure with the addition of a subacromial balloon spacer (n=56). The primary outcome was the Oxford Shoulder Score (OSS) at 24 months. Secondary outcomes included the Western Ontario Rotator Cuff Index (WORC), EQ-5D-5L, patient satisfaction, and the Participant Global Impression of Change. Outcomes were assessed up to 24 months. Overall, the results of the study revealed no statistically significant difference in OSS at 24 months, and the WORC and patient global impression scores significantly favored the debridement-only group. The findings suggest that adding a subacromial balloon spacer offers no functional benefit and may be associated with worse subjective outcomes.
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