1. The control group (debridement-only) reported better clinical outcomes at 12 months compared to the intervention group (debridement with balloon spacer).
2. Majority of adverse events were mild and comparable between both groups.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Rotator cuff tears often cause severe pain and disability. Although most rotator cuff tears can be fixed, a small proportion are irreparable. These patients may experience increasing pain and declining functional status. The InSpace subacromial balloon spacer uses a biodegradable cushion to facilitate mobility of the affected joint. This novel technique received FDA approval in July 2021; however, evidence surrounding its clinical use is lacking. This randomized double-blind controlled trial aimed to determine the safety and efficacy of the subacromial balloon spacer for treatment of irreparable rotator cuff tears. The primary outcome was mean Oxford Shoulder Score (OSS; 0-48) at 12 months, while key secondary outcomes included the Western Ontario Rotator Cuff (WORC) index (0-100), EuroQol ED-5D-5L score, and adverse events. According to study results, the debridement-only group yielded better clinical outcomes, at 12 months, than the subacromial balloon spacer group. Recruitment and randomization for this study was interrupted after the first interim analysis as the OSS scores crossed the futility boundary. This study was limited by a small sample size of patients, affecting its generalizability.
In-depth [randomized-controlled trial]: Between Jun 1, 2018, and Jul 30, 2020, 385 patients were assessed for eligibility across 24 hospitals in the UK. Included were those with an irreparable rotator cuff tear requiring surgery. Altogether, 114 patients (59 in the debridement-only [control] group and 55 in the debridement with device [intervention] group) were included in the intention-to-treat analysis. The primary outcome of OSS at 12 months was greater in the control group compared to the intervention group (34.3, standard deviation [SD] 11.1 vs. 30.3, SD 10.9, p=0.037). Likewise, the secondary outcomes concerning WORC index (mean adjusted difference [MAD] -8.4, 95% confidence interval [CI] -16.8 to -0.1, p=0.055) and Euroqol EQ-5D-5L (MAD -0.056, 95% CI -0.150 to 0.035, p=0.24) favored the control group, although these were not statistically significant. Major adverse events were similar, with one patient in each group reporting pain and disability at 12 months. No deaths were reported. Overall, findings from this study suggest that the subacromial balloon spacer does not provide additional benefits, beyond what is currently available, for the treatment of irreparable rotator cuff tears.
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