Off-label use of reverse total shoulder arthroplasty: the American Academy of Orthopedic Surgeons Shoulder and Elbow Registry

Abstract

HypothesisAfter the popularity of reverse total shoulder arthroplasty (rTSA) in Europe, the United States Food and Drug Administration (FDA) cleared the Delta rTSA system (DePuy Inc., Warsaw, IN, USA) for use in late 2003. The original FDA approved indications for rTSA in the United States were limited to a “Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint.” Surgeons began to use rTSA for many off-label indications: osteoarthritis (OA) without rotator cuff tear (RCT), massive RCT without OA, proximal humerus fractures (PHFx), inflammatory arthritis (IA), and chronic glenohumeral joint dislocation (GHJD). Since 2006, The FDA has approved PHFx as an indication for some but not all reverse implants. The purpose of this study is to evaluate the trends in off-label rTSA use in the American Academy of Orthopaedic Surgeons Shoulder and Elbow Registry (AAOS-SER). MethodsAll rTSA procedures reported to the AAOS-SER from January 2015 to March 2021 were analyzed. Diagnoses associated with the use of rTSA including RCT arthropathy, OA without RCT, RCT without OA, PHFx, IA, and GHJD were evaluated, and trends were assessed over the data collection period. ResultsAt the time of data analysis the AAOS-SER contained 3850 cases of rTSA. Only 24.4% of rTSA surgeries were performed for original on-label use (RCT arthropathy). Off-label use of rTSA was seen in 75.6% of cases. When reviewing those rTSA done off-label, the majority (41.4%) were done for OA without RCT. Other off-label rTSA use included 15.1% for RCT without OA, 13% potentially off-label for PHFx, 4.6% for IA, and 1.6% for GHJD. Proportionally, off-label use is increasing over time while on-label use is decreasing. ConclusionIn the AAOS-SER, the majority of rTSA were performed for indications originally considered off-label by the FDA-a trend increasing over time. Some implant manufacturers have expanded indications for rTSA without providing clinical data to support changing FDA approved indications for use. The incremental expansion of indications for use without supportive data, a practice known as predicate creep, is occurring with rTSA. Performing rTSA for off-label indications may create liability risk for surgeons and implant manufacturers. Device manufacturers should formally expand indications of use for rTSA with the FDA to be consistent with published literature and trends.