A multicenter, prospective 2-year analysis of the Sidus stem-free shoulder arthroplasty system

Background The purpose of this multicenter, prospective study was to evaluate the efficacy and safety of a stemless total shoulder arthroplasty compared with a traditional stemmed control. Methods Ninety-five shoulders were selected for participation in this Food and Drug Administration investigational device exemption clinical trial and underwent stemless total shoulder arthroplasty. Subjects returned for follow-up at 6 weeks, 6 months, 12 months, and 2 years postoperatively. Outcome measures included pain; range of motion; American Shoulder and Elbow Surgeons, Western Ontario Osteoarthritis of the Shoulder, and Short Form 12 scores; and radiographic review. Baseline data were compared with 2-year follow-up data to determine the rate of composite clinical success compared with the stemmed control. Results All outcome assessments demonstrated significant improvements (P ≤ .007). The mean American Shoulder and Elbow Surgeons score improved from 20 to 89 (P Conclusions This study showed that a stemless rough-blasted humeral implant with metaphyseal bone fixation provides good clinical and radiographic outcomes and survivorship at 2 years, with outcomes comparable to a traditional stemmed implant.