Cemented versus uncemented fixation of humeral components in total shoulder arthroplasty for osteoarthritis of the shoulder: a prospective, randomized, double-blind clinical trial—A JOINTs Canada Project

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• 作者：Robert B. Litchfield MD ; FRCSC^a ; Micheal D. McKee MD ; FRCSC^b ; Robert Balyk MD ; FRCSC^c ; Scott Mandel MD ; FRCSC^d ; Richard Holtby MD ; FRCSC^e ; Robert Hollinshead MD ; FRCSC^f ; Darren Drosdowech MD ; FRCSC^g ; S. Elizabeth Wambolt CRA^h ; Sharon H. Griffin CSS ; CIM^a ; Robert McCormack MD ; FRCSCⁱ ; ^{bobmccormack@telus.net"" rel=""nofollow}
• 关键词：TSA ; randomized clinical trial ; cemented fixation ; press-fit fixation
• 刊名：Journal of Shoulder and Elbow Surgery
• 出版年：2011
• 出版时间：June 2011
• 年：2011
• 卷：20
• 期：4
• 页码：529-536
• 全文大小：187 K

文摘

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.