Bourne Robert B, Corten Kristoff
Adult Reconstructive Unit, University Hospital, University of Western Ontario, London, Ontario, Canada.
Orthopedics. 2010 Sep 7;33(9):638. doi: 10.3928/01477447-20100722-24.
The purpose of this randomized clinical trial was to compare the >20-year outcomes of cemented (n=124) versus cementless (n=126) total hip replacements (THRs) in patients with end-stage, unilateral hip osteoarthritis. At 20 years, 168 patients (67%) were available for follow-up, 78 (31%) had died, and 4 (2%) were lost. A power analysis was performed to determine the number of patients needed in each study cohort. Patients were assessed pre- and postoperatively by validated disease-specific Western Ontario McMaster Osteoarthritis Score, patient-specific McMaster Arthritis Score, global health (sickness impact profile), functional capacity (6-minute walk), and cost utility (cost-to-quality adjusted life years). Patients were followed every 2 years clinically and radiographically.The cementless THR outperformed its cemented counterpart in terms of overall (P=.01), socket (P=.009), and stem (P<.0001) Kaplan-Meier survivorships. Patients younger than 65 years had significantly poorer cemented and cementless socket survivorships, and male sex adversely affected cementless socket survivorship. The cementless tapered stem had 100% survivorship with aseptic loosening as the endpoint at 20 years. Although this study has demonstrated the superiority of the cementless THR over its cemented counterpart, care must be taken in generalizing these results to other cemented and cementless THRs.
这项随机临床试验的目的是比较终末期单侧髋关节骨关节炎患者中,骨水泥型(n = 124)与非骨水泥型(n = 126)全髋关节置换术(THR)的20年以上疗效。20年后,168例患者(67%)可供随访,78例(31%)死亡,4例(2%)失访。进行了效能分析以确定每个研究队列所需的患者数量。术前和术后通过验证的疾病特异性西安大略和麦克马斯特大学骨关节炎评分、患者特异性麦克马斯特关节炎评分、整体健康状况(疾病影响概况)、功能能力(6分钟步行试验)和成本效用(成本-质量调整生命年)对患者进行评估。每2年对患者进行临床和影像学随访。非骨水泥型THR在总体(P = .01)、髋臼(P = .009)和股骨柄(P < .0001)的Kaplan-Meier生存率方面优于骨水泥型THR。年龄小于65岁的患者,骨水泥型和非骨水泥型髋臼的生存率明显较差,男性对非骨水泥型髋臼的生存率有不利影响。以无菌性松动为终点,非骨水泥型锥形股骨柄在20年时的生存率为100%。尽管本研究已证明非骨水泥型THR优于骨水泥型THR,但将这些结果推广到其他骨水泥型和非骨水泥型THR时仍需谨慎。