High Rate of Clinically Meaningful Achievement in Outcomes After Subacromial Balloon Spacer Implantation for Massive Irreparable Rotator Cuff Tears: A Systematic Review and Meta-analysis.

BACKGROUND Subacromial balloon spacers have been introduced as a potential treatment option for patients with massive irreparable rotator cuff tears. However, it is important to comprehensively assess the clinical efficacy of this procedure in the context of an increasing amount of contemporary literature. PURPOSE To perform a systematic review of the contemporary literature to understand the propensity for clinically meaningful improvements after subacromial balloon spacer implantation for massive irreparable rotator cuff tears. STUDY DESIGN Systematic review and meta-analysis; Level of evidence, 4. METHODS The PubMed, Ovid/MEDLINE, and Cochrane databases were queried in July 2022 for data pertaining to studies reporting clinically significant outcomes after subacromial balloon spacer implantation. Freeman-Tukey double arcsine transformation was used to quantify the pooled rate of clinically meaningful improvements in outcomes as evaluated using the minimal clinically important difference (MCID), Patient Acceptable Symptom State (PASS), and substantial clinical benefit (SCB). Qualitative analysis was performed when data were variably presented to avoid misleading reporting. RESULTS There were 10 studies included, all of which reported MCID achievement. The overall pooled rate of MCID achievement for the Constant-Murley score was 83% (95% CI, 71%-93%; range, 40%-98%), with 6 of 8 studies reporting rates equal to or exceeding 85%. One study reported a 98% rate of PASS achievement for the Constant-Murley score at 3-year follow-up. The rate of MCID achievement for the American Shoulder and Elbow Surgeons (ASES) score ranged between 83% and 87.5%. The rate of PASS achievement for the ASES score was 56% at 2-year follow-up, while the rate of SCB achievement for the ASES score was 83% and 82% at 1- and 2-year follow-up, respectively. At 1-year follow-up, 74% and 78% of patients achieved the MCID for the Numeric Rating Scale and Oxford Shoulder Score, respectively. At 3 years, 69% of patients achieved the MCID for the Numeric Rating Scale and 87% achieved it for the Oxford Shoulder Score. CONCLUSION Patients who underwent isolated subacromial balloon spacer implantation for massive irreparable rotator cuff tears demonstrated a high rate of clinically significant improvement in outcomes at short- to mid-term follow-up. A paucity of literature exists to appropriately define and evaluate the rates of achieving the PASS and SCB after subacromial balloon spacer implantation, necessitating further study.