Meander Medical Center, Amersfoort, The Netherlands.
J Bone Joint Surg Am. 2011 Jul 6;93(13):1249-55. doi: 10.2106/JBJS.I.01792.
Except for those reported by the designers, there are no published mid-term results of the use of the CementLess Spotorno (CLS) Total Hip Arthroplasty system. We present the results of (1) a ten to seventeen-year follow-up prospective cohort study of this system, and (2) retrospective analyses of factors influencing clinical and radiographic outcomes.
We studied a series of 102 consecutive CLS arthroplasties with a minimal duration of follow-up of ten years. Indications for the procedures were osteoarthritis (n = 90), rheumatoid arthritis (n = 8), and femoral head osteonecrosis (n = 4). The Merle d'Aubigné-Postel score, polyethylene wear, and radiographic status were recorded at regular intervals. Survival analyses, repeated-measures analysis of variance, and a nested case-control study (with the cases having early revision due to aseptic cup loosening within ten years after the index procedure and the controls having no early cup revision) were used for evaluation.
There were fourteen revisions, including nine due to aseptic cup loosening. The ten-year Kaplan-Meier survival rate was 92.2% (95% confidence interval [CI] = 86.9 to 97.5) with revision for any reason as the end point. The fifteen-year survival rate was 78.4% (95% CI = 63.9 to 92.9) with revision for any reason as the end point, 81.6% (95% CI = 66.7 to 96.5) with revision due to aseptic cup loosening as the end point, and 99.0% (95% CI = 97.0 to 100.0) with revision due to aseptic stem loosening as the end point. The average amount of polyethylene wear at the time of final follow-up was 1.92 mm (range, 0.6 to 4.3 mm). The wear rate in the cases was significantly higher than that in the controls (0.31 vs. 0.16 mm/yr, p < 0.001). Factors with a significant effect on polyethylene wear were age at surgery (a 0.3-mm increase per every ten years younger, p = 0.001) and a larger head component (an effect of 0.53 mm for the 32 vs. the 28-mm component; p < 0.0001). Male sex had an effect of -0.66 point (p = 0.07) on the final Merle d'Aubigné-Postel score.
The results of this CLS system, particularly with regard to the femoral stem, are comparable with those with other reliable cementless systems. Nevertheless, the prevalence of aseptic acetabular cup loosening in the second decade after the operation demonstrates a potentially substantial problem with regard to long-term survival. A high polyethylene wear rate, male sex, a younger age at the time of surgery, and a 32-mm head component size are related to inferior clinical outcomes and a higher risk of implant revision.
除设计者报告的内容外，目前尚无 CementLess Spotorno（CLS）全髋关节置换系统中期结果的相关文献。我们对该系统进行了（1）十年至十七年的前瞻性队列研究随访，（2）对影响临床和影像学结果的因素进行了回顾性分析。
我们研究了一系列连续的 102 例 CLS 髋关节置换术，最低随访时间为十年。手术适应证为骨关节炎（n = 90）、类风湿关节炎（n = 8）和股骨头坏死（n = 4）。采用 Merle d'Aubigné-Postel 评分、聚乙烯磨损和影像学状态进行定期评估。采用生存分析、重复测量方差分析和嵌套病例对照研究（病例为初次手术后十年内因无菌性髋臼杯松动而早期翻修，对照组无早期髋臼杯翻修）进行评估。
共有 14 例翻修，其中 9 例因无菌性髋臼杯松动。以任何原因翻修为终点时，十年 Kaplan-Meier 生存率为 92.2%（95%置信区间 [CI] = 86.9 至 97.5）。以任何原因翻修为终点时，十五年生存率为 78.4%（95%CI = 63.9 至 92.9），以无菌性髋臼杯松动翻修为终点时为 81.6%（95%CI = 66.7 至 96.5），以无菌性股骨柄松动翻修为终点时为 99.0%（95%CI = 97.0 至 100.0）。末次随访时平均聚乙烯磨损量为 1.92mm（范围：0.6 至 4.3mm）。病例组的磨损率明显高于对照组（0.31 比 0.16mm/yr，p < 0.001）。对聚乙烯磨损有显著影响的因素为手术时的年龄（每 10 岁增加 0.3mm，p = 0.001）和较大的股骨头组件（32mm 比 28mm 组件的影响为 0.53mm；p < 0.0001）。男性（p = 0.07）对最终 Merle d'Aubigné-Postel 评分有-0.66 分的影响。
该 CLS 系统的结果，尤其是股骨柄的结果，与其他可靠的非骨水泥系统相当。然而，术后第二个十年无菌性髋臼杯松动的发生率表明，长期生存存在潜在的重大问题。高聚乙烯磨损率、男性、手术时年龄较小和 32mm 股骨头组件尺寸与临床结局较差和植入物翻修风险增加有关。
