London Health Sciences Centre, University Campus, 339 Windermere Road, London, ON N6A 5A5, Canada.
Clin Orthop Relat Res. 2011 Jan;469(1):209-17. doi: 10.1007/s11999-010-1459-5. Epub 2010 Jul 13.
Total hip arthroplasty (THA) has been associated with high survival rates, but debate remains concerning the best fixation mode of THA.
QUESTIONS/PURPOSES: We conducted a randomized controlled trial (RCT) with 250 patients with a mean age of 64 years between October 1987 and January 1992 to compare the results of cementless and cemented fixation.
Patients were evaluated for revision of either of the components. One hundred twenty-seven patients had died (51%) and 12 (4.8%) were lost to followup. The minimum 17-year followup data (mean, 20 years; range, 17-21 years) for 52 patients of the cementless group and 41 patients of the cemented group were available for evaluation.
Kaplan-Meier survivorship analysis at 20 years revealed lower survival rates of cemented compared with cementless THA. The cementless tapered stem was associated with a survivorship of 99%. Age younger than 65 years and male gender were predictors of revision surgery.
The efficacy of future RCTs can be enhanced by randomizing patients in specific patient cohorts stratified to age and gender in multicenter RCTs. Including only younger patients might improve the efficacy of a future RCT with smaller sample sizes being required. A minimum 10-year followup should be anticipated, but this can be expected to be longer if the difference in level of quality between the compared implants is smaller.
Level I, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.
全髋关节置换术（THA）的存活率很高，但关于 THA 的最佳固定模式仍存在争议。
问题/目的：我们进行了一项随机对照试验（RCT），纳入了 1987 年 10 月至 1992 年 1 月间的 250 名平均年龄为 64 岁的患者，比较了骨水泥固定和非骨水泥固定的结果。
评估了两种固定方式的翻修情况。127 名患者死亡（51%），12 名（4.8%）患者失访。我们获得了非骨水泥组 52 名患者和骨水泥组 41 名患者的最低 17 年随访数据（平均 20 年；范围 17-21 年），用于评估。
20 年的 Kaplan-Meier 生存分析显示，骨水泥固定的 THA 生存率低于非骨水泥固定。非骨水泥锥形柄的生存率为 99%。年龄小于 65 岁和男性是翻修手术的预测因素。
在多中心 RCT 中，按年龄和性别分层将患者随机分组，可以提高未来 RCT 的有效性。只纳入年轻患者可能会提高未来 RCT 的效果，所需的样本量更小。预计需要至少 10 年的随访，但如果比较的植入物之间的质量差异较小，则可能需要更长的时间。
I 级，治疗性研究。有关证据水平的完整描述，请参见作者指南。
