InSpace Balloon for the Management of Massive Irreparable Rotator Cuff Tears: A Systematic Review and Meta-Analysis.

Background: The best course of action for massive irreparable rotator cuff tears (MIRCTs) is not universally agreed upon. Numerous surgical techniques have been discussed. The implantation of a biodegradable spacer into the subacromial area has been documented since 2012 by several authors. The implantation method is touted as being simpler, repeatable, and less invasive than other solutions that are now available. The purpose of this systematic review and meta-analysis, being the first of its kind, was to evaluate the literature to see the efficacy of InSpace balloon (ISB) implantation in the management of MIRCTs. Methods: Following Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines, and with 2 researchers assessing and analyzing each study separately, an extensive electronic search of the literature was conducted in the PubMed database from 1961 until July 27, 2022. Results: Fourteen studies were included in this systematic review and three in the meta-analysis. Eleven out of fourteen studies favored ISB use for MIRCTs, while only three were against its use. All spacers were arthroscopically implanted in the subacromial space. Three studies were included in the meta-analysis. The differences in the compared outcomes were statistically insignificant. Conclusions: A controversy about the use of ISB remains in patients with MIRCTs. Both good and bad outcomes were reported. However, the majority of patients had good clinical outcomes across several grading scales, radiographic evidence of improved impingement, and self-report that they would redo the procedure in hindsight. To draw more solid conclusions and have statistically significant results in the meta-analysis, more randomized controlled trials and comparative studies comparing this device to other treatments are needed.