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

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.

RCT Entities:   Population Interventions Outcomes