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羟基磷灰石对全膝关节假体微动的影响。一项前瞻性、随机、双盲研究。

The effect of hydroxyapatite on the micromotion of total knee prostheses. A prospective, randomized, double-blind study.

作者信息

Nelissen R G, Valstar E R, Rozing P M

机构信息

Department of Orthopaedic Surgery, Leiden University Medical Centre, The Netherlands.

出版信息

J Bone Joint Surg Am. 1998 Nov;80(11):1665-72. doi: 10.2106/00004623-199811000-00014.

Abstract

A prospective, randomized, double-blind study was performed to evaluate three different means of fixing tibial components during total knee arthroplasty. Eleven components fixed with cement, ten hydroxyapatite-coated components fixed without cement, and ten noncoated components fixed without cement were studied. A posterior cruciate ligament-retaining total condylar implant was used. Micromotion of the components was assessed with roentgen stereophotogrammetric analysis during the two-year follow-up period. There were no significant differences among the patients with regard to age (mean [and standard deviation], 68 +/- 11.6 years), body-mass index (mean, 23 +/- 2.8 kilograms per square meter), or stage of osteoarthrosis (mean, 4 +/- 2.4 according to the classification system of Ahlback and 5 +/- 0.6 according to that of Larsen et al.). The diagnosis was osteoarthrosis in five knees, and it was rheumatoid arthritis in twenty-six. The clinical scores were similar among the study groups. According to the system of the Knee Society, the mean preoperative functional score was 10 +/- 2.9 points and the mean preoperative knee score was 24 +/- 3.2 points. At the two-year follow-up evaluation, these scores were 41 +/- 8.3 and 79 +/- 3.2 points, respectively. A significant difference with regard to micromotion was found between the noncoated components fixed without cement and the hydroxyapatite-coated components fixed without cement as well as between the noncoated components fixed without cement and the components fixed with cement (p < 0.001, analysis of variance). The hydroxyapatite-coated components fixed without cement and the components fixed with cement both had far less micromotion along the longitudinal axis (subsidence) throughout the follow-up period than did the noncoated components fixed without cement. At the two-year follow-up evaluation, the subsidence of the noncoated components was -0.73 +/- 0.924 millimeter, the subsidence of the cemented components was -0.05 +/- 0.109 millimeter, and the subsidence of the hydroxyapatite-coated components was -0.06 +/- 0.169 millimeter. The cemented components as well as the hydroxyapatite-coated components also had less translation along the transverse axis (p < 0.001, analysis of variance) and the sagittal axis (p < 0.001, analysis of variance) compared with the noncoated components. In conclusion, micromotion of hydroxyapatite-coated tibial components fixed without cement was similar to that of tibial components fixed with cement. Therefore, hydroxyapatite, a biological mediator, may be necessary for the adequate fixation of tibial components when cement is not used.

摘要

进行了一项前瞻性、随机、双盲研究,以评估全膝关节置换术中固定胫骨组件的三种不同方法。研究了11个用骨水泥固定的组件、10个无骨水泥固定的羟基磷灰石涂层组件和10个无骨水泥固定的非涂层组件。使用了保留后交叉韧带的全髁植入物。在两年的随访期内,采用X线立体摄影测量分析评估组件的微动情况。患者在年龄(平均[及标准差],68±11.6岁)、体重指数(平均,23±2.8千克/平方米)或骨关节炎分期(根据阿尔贝克分类系统平均为4±2.4,根据拉森等人的分类系统平均为5±0.6)方面无显著差异。诊断为骨关节炎的有5例膝关节,类风湿关节炎的有26例。各研究组的临床评分相似。根据膝关节协会系统,术前平均功能评分为10±2.9分,术前平均膝关节评分为24±3.2分。在两年的随访评估中,这些评分分别为41±8.3分和79±3.2分。发现无骨水泥固定的非涂层组件与无骨水泥固定的羟基磷灰石涂层组件之间以及无骨水泥固定的非涂层组件与用骨水泥固定的组件之间在微动方面存在显著差异(方差分析,p<0.001)。在整个随访期内,无骨水泥固定的羟基磷灰石涂层组件和用骨水泥固定的组件沿纵轴(下沉)的微动均远少于无骨水泥固定的非涂层组件。在两年的随访评估中,非涂层组件的下沉为-0.73±0.924毫米,骨水泥固定组件的下沉为-0.05±0.109毫米,羟基磷灰石涂层组件的下沉为-0.06±0.169毫米。与非涂层组件相比,骨水泥固定组件以及羟基磷灰石涂层组件在横轴(方差分析,p<0.001)和矢状轴(方差分析,p<0.001)上的平移也较少。总之,无骨水泥固定的羟基磷灰石涂层胫骨组件的微动与用骨水泥固定的胫骨组件相似。因此,当不使用骨水泥时,作为生物介质的羟基磷灰石可能是胫骨组件充分固定所必需的。

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