Ochs U, Ilchmann T, Ochs B G, Marx J, Brunnhuber K, Lüem M, Weise K
BG Trauma Centre, University of Tuebingen, Schnarrenbergstrasse 95, Tuebingen, Germany.
Z Orthop Unfall. 2007 Sep-Oct;145 Suppl 1:S20-4. doi: 10.1055/s-2007-965655.
In this prospective randomised study, the influence of different bearing materials on migration and wear was measured and their effect on the function of the artificial joint and the patient outcome was investigated. Mid-term results were recorded so that recommendations can be made on the use of certain bearings, which minimise wear and thus the danger of subsequent aseptic loosening.
Sixty-six patients met the inclusion criteria and were willing to take part in the study. These patients were randomised to 2 groups. All of them had total hip arthroplasty with implantation of a cementless Bicontact stem and Plasmacup using a cementless press-fit technique. Thirty-five of these patients were given a ceramic-ceramic bearing and 31 patients a ceramic-polyethylene bearing (gamma sterilised/nitrogen environment). At the most recent follow-up, they underwent detailed clinical and radiological examination and evaluation by means of the Harris Hip Score, Hannover function questionnaire and single-film X-ray analysis (EBRA).
The overall follow-up rate was 65.2 % (43 of 66) and the mean follow-up period was 8.1 (7.1 - 9.2) years. The median Harris Hip Score at the time of follow-up was 90.1 (58.7 - 99.9) points. The average Hannover function score was 87.14 % (63.9 - 100). In 4 of 66 cases (6.1 %) there was a tendency for the Plasmacup to subsidence in the first postoperative months that was slight but detectable by EBRA; however, this stopped subsequently. This primary subsidence was independent of the chosen bearing material. No significant difference in the clinical and radiological parameters was found between the two groups.
The very good results with regard to the rate of loosening confirm the press-fit cup fixation concept. The study shows a similar medium-term result for the ceramic-ceramic and ceramic-polyethylene bearing so that use of both bearings can continue to be recommended. Only long-term studies with sufficiently large numbers of patients will be able to show whether significant differences can be detected between the two slide bearings with regard to wear and migration behaviour and so that a recommendation can be given to the surgeon.
在这项前瞻性随机研究中,测量了不同轴承材料对移位和磨损的影响,并研究了它们对人工关节功能和患者预后的作用。记录中期结果,以便就某些轴承的使用提出建议,这些轴承可将磨损降至最低,从而降低随后无菌性松动的风险。
66例患者符合纳入标准并愿意参与研究。这些患者被随机分为两组。他们均接受了全髋关节置换术,采用非骨水泥压配技术植入非骨水泥双接触柄和等离子髋臼杯。其中35例患者使用陶瓷-陶瓷轴承,31例患者使用陶瓷-聚乙烯轴承(γ射线灭菌/氮气环境)。在最近一次随访时,他们接受了详细的临床和放射学检查,并通过Harris髋关节评分、汉诺威功能问卷和单张X线片分析(EBRA)进行评估。
总体随访率为65.2%(66例中的43例),平均随访时间为8.1(7.1 - 9.2)年。随访时Harris髋关节评分中位数为90.1(58.7 - 99.9)分。汉诺威功能平均评分为87.14%(63.9 - 100)。66例中有4例(6.1%)在术后最初几个月出现等离子髋臼杯轻微下沉趋势,EBRA可检测到;然而,随后这种情况停止了。这种初期下沉与所选轴承材料无关。两组在临床和放射学参数上未发现显著差异。
在松动率方面的良好结果证实了压配杯固定概念。该研究表明陶瓷-陶瓷轴承和陶瓷-聚乙烯轴承的中期结果相似,因此两种轴承的使用均可继续推荐。只有大量患者参与的长期研究才能表明这两种滑动轴承在磨损和移位行为方面是否能检测到显著差异,从而为外科医生提供建议。