Reassessing the minimum two-year follow-up standard after total shoulder arthroplasty—Is one year sufficient?

Abstract

Background US Food and Drug Administration Investigation Device Exemption studies and academic journals emphasize the importance of two-year follow-up data in reporting outcomes of total shoulder arthroplasty, but there is limited data evaluating appropriate follow-up length. We aim to evaluate change in postoperative outcomes and complications between one and two years following anatomic and reverse total shoulder arthroplasties. Methods We retrospectively identified 250 patients who underwent anatomic and reverse total shoulder arthroplasties between 2013 and 2016 from a single surgeon arthroplasty registry. Patients without both one- and two-year follow-up data were excluded. We compared American Shoulder and Elbow Surgeons (ASES) score, Visual Analog Scale for pain, and goniometer-measured range of motion. Results Patient-reported outcome measurements ( p > 0.05) did not change between one and two years postoperatively following both reverse ( n = 146) and anatomic ( n = 104) total shoulder arthroplasties. Range of motion increased slightly ( p < 0.05), but this change was not clinically relevant. There were no additional complications. Discussion Minimum two-year clinical follow-up may not be necessary for future shoulder arthroplasty Investigation Device Exemption and other peer-reviewed investigations. Patient-reported outcomes (ASES and pain score) and range of motion plateau at one year postoperatively without additional complications. One-year follow-up is an acceptable minimum follow-up length. Level of evidence Level III—retrospective analysis.