Immediate Accelerated Shoulder Rehabilitation (IASR) vs. Standard Protocol following Reverse Total Shoulder Arthroplasty: A Randomized Controlled Trial.

Abstract

Background: Recently, the reverse total shoulder arthroplasty (rTSA) became the most frequently performed form of shoulder replacement in the United States and abroad. While physical therapy is universally accepted and routinely practiced, published postoperative rehabilitation guidelines and modifications are based on protocols developed in 1975. Since then, the principle components and temporal concepts of timing and intensity of postoperative rehabilitation and protected immobilization have been controversially applied and expertly discussed without a prevailing consensus. Comparative literature that prospectively addresses treatment differences, influences on outcomes, and superiority or inferiority versus control does not exist. Thus, the objective of this pilot study is to compare an accelerated and immediate active shoulder rehabilitation (IASR) rehabilitation program with standard care in patients following rTSA. Methods:A prospective, randomized, controlled, parallel-designed, two-armed, non-blinded, superiority pilot trial. The comparator arms are an accelerated rehabilitation (IASR) strategy versus standardized care following rTSA (CPT: 23472). The primary outcome measures will be the change from pre-surgical baseline to 52 weeks post-surgery in the American Shoulder and Elbow (ASES) score, Simple Shoulder Test (SST), and global health assessment (PROMIS-10. Secondary and tertiary outcomes will assess subscapularis integrity, implant status, and overall rehabilitation costs compared to formal control. Patients will be recruited from a single site (TRIA Orthopaedic Center, Bloomington, MN) neighboring the fourteenth largest US metropolitan area.Discussion: This trial will be the first study to compare the efficacy and safety of two different postoperative rehabilitation strategies for patients following rTSA. Further, this will be the first study to investigate an accelerated rehabilitation program without a period of protected immobilization following rTSA. Finally, the results will assist in the shared clinical and surgical treatment decisionmaking process.