Limited Clinical Benefit of the Subacromial Balloon Spacer in Massive Irreparable Rotator Cuff Tears: A Comprehensive Review of Clinical Outcomes and Cost-Effectiveness.

» Subacromial balloon spacer (SBS) implantation has been proposed as a minimally invasive treatment for massive irreparable rotator cuff tears (MIRCTs), particularly in elderly patients with preserved glenohumeral articulation and limited functional demands.» Across observational studies, SBS has been associated with short to midterm improvements in pain and shoulder function, reflected by increases in ASES and Constant-Murley scores.» Evidence from randomized controlled trials is mixed; the SPACE trial showed SBS is noninferior to partial repair, while the START:REACTS trial found it less effective than debridement alone.» Complications are uncommon and primarily include balloon migration, synovitis, and rare infections, supporting SBS's safety profile when patient selection is appropriate.» Based on current high-level evidence, SBS is not recommended for routine treatment of MIRCT. Its use should be restricted to carefully selected elderly patients with chronic, nonarthritic MIRCT who are poor candidates for other reconstructive procedures.