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

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 ( > 0.05) did not change between one and two years postoperatively following both reverse ( = 146) and anatomic ( = 104) total shoulder arthroplasties. Range of motion increased slightly ( < 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.