Department of Orthopaedic and Trauma Surgery, Caen Côte de Nacre Teaching Hospital, Center, avenue de la Côte-de-Nacre, 14033 Caen cedex France.
Orthop Traumatol Surg Res. 2010 Oct;96(6):609-15. doi: 10.1016/j.otsr.2010.04.007. Epub 2010 Jul 23.
The use of dual mobility cups is an effective method to prevent dislocations. However, the specific design of these implants can raise the suspicion of increased wear and subsequent periprosthetic osteolysis.
Using radiostereometric analysis (RSA), migration of the femoral head inside the cup of a dual mobility implant can be defined to apprehend polyethylene wear rate.
The study aimed to establish the precision of RSA measurement of femoral head migration in the cup of a dual mobility implant, and its intra- and interobserver variability.
A total hip prosthesis phantom was implanted and placed under weight loading conditions in a simulator. Model-based RSA measurement of implant penetration involved specially machined polyethylene liners with increasing concentric wear (no wear, then 0.25, 0.5 and 0.75mm). Three examiners, blinded to the level of wear, analyzed (10 times) the radiostereometric films of the four liners. There was one experienced, one trained, and one inexperienced examiner. Statistical analysis measured the accuracy, precision, and intra- and interobserver variability by calculating Root Mean Square Error (RMSE), Concordance Correlation Coefficient (CCC), Intra Class correlation Coefficient (ICC), and Bland-Altman plots.
Our protocol, that used a simple geometric model rather than the manufacturer's CAD files, showed precision of 0.072mm and accuracy of 0.034mm, comparable with machining tolerances with low variability. Correlation between wear measurement and true value was excellent with a CCC of 0.9772. Intraobserver reproducibility was very good with an ICC of 0.9856, 0.9883 and 0.9842, respectively for examiners 1, 2 and 3. Interobserver reproducibility was excellent with a CCC of 0.9818 between examiners 2 and 1, and 0.9713 between examiners 3 and 1.
Quantification of wear is indispensable for the surveillance of dual mobility implants. This in vitro study validates our measurement method. Our results, and comparison with other studies using different measurement technologies (RSA, standard radiographs, Martell method) make model-based RSA the reference method for measuring the wear of total hip prostheses in vivo.
Level 3. Prospective diagnostic study.
双动杯的使用是预防脱位的有效方法。然而,这些植入物的具体设计可能会增加磨损的嫌疑,并随后导致假体周围骨溶解。
使用放射立体测量分析(RSA),可以定义股骨头在双动植入物杯内的迁移,以了解聚乙烯的磨损率。
本研究旨在确定 RSA 测量双动植入物杯内股骨头迁移的精度及其在观察者内和观察者间的可变性。
将全髋关节假体模型植入模拟器中,并在负重条件下放置。基于模型的 RSA 测量包括专门加工的具有不同同心磨损的聚乙烯衬垫(无磨损、0.25mm、0.5mm 和 0.75mm)。三位观察者在不知道磨损程度的情况下分析了(10 次)四个衬垫的放射立体照片。其中一位经验丰富,一位有培训,一位没有经验。统计分析通过计算均方根误差(RMSE)、一致性相关系数(CCC)、组内相关系数(ICC)和 Bland-Altman 图来测量准确性、精密度和观察者内和观察者间的可变性。
我们的方案使用简单的几何模型而不是制造商的 CAD 文件,精度为 0.072mm,准确性为 0.034mm,与加工公差相比具有低变异性。磨损测量与真实值之间的相关性极好,CCC 为 0.9772。观察者内重复性非常好,观察者 1、2 和 3 的 ICC 分别为 0.9856、0.9883 和 0.9842。观察者间重复性极好,观察者 2 和 1 之间的 CCC 为 0.9818,观察者 3 和 1 之间的 CCC 为 0.9713。
双动植入物的磨损量化对于监测是必不可少的。本体外研究验证了我们的测量方法。我们的结果以及与使用不同测量技术(RSA、标准射线照片、Martell 方法)的其他研究的比较使基于模型的 RSA 成为测量体内全髋关节假体磨损的参考方法。
3 级。前瞻性诊断研究。