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Background: Although cemented humeral fixation is recognized as the standard of care in total shoulder arthroplasty (TSA), uncemented fixation has the potential to provide stable fixation, decrease operative time, and simplify potential revision procedures. This prospective, randomized, double-blind clinical trial compared cemented and uncemented humeral fixation in TSA for primary shoulder osteoarthritis., Methods: Patients with primary shoulder osteoarthritis requiring replacement were screened for eligibility. After providing informed consent, subjects received baseline clinical and radiologic assessments, computed tomography scans, and standardized TSA. After glenoid component insertion, patients were randomized to either a cemented or uncemented humeral component. The primary outcome was the WOOS (Western Ontario Arthritis of the Shoulder Index) score at 2 years. Other outcomes included the Short Form 12 score, American Shoulder and Elbow Surgeons score, McMaster-Toronto Arthritis Patient Preference Disability Questionnaire, operative time, complications, and revisions. Patients were assessed by a blinded evaluator at 2 and 6 weeks and 3, 6, 12, 18, and 24 months postoperatively., Results: In total, 161 patients consented to be included and were randomized: 80 in the cemented group and 81 in the uncemented group. There were no significant differences in demographics or baseline evaluations between groups, except for gender. The 12-, 18-, and 24-month WOOS scores showed a significant difference in favor of the cemented group. The cemented group also had better strength and forward flexion. As expected, the operative time was significantly less for the uncemented group., Conclusions: These findings provide level I evidence that cemented fixation of the humeral component provides better quality of life, strength, and range of motion than uncemented fixation., (Copyright © 2011 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.)