A randomized trial of hydroxyapatite coated prostheses in total hip arthroplasty.

In a prospective randomized trial, 62 consecutive primary cementless total hip arthroplasties in 55 patients were performed by one surgeon using either hydroxyapatite coated (35 hips) or nonhydroxyapatite coated femoral prostheses (27 hips). The dual tapered femoral stem had a Ti-6AI-4V plasma sprayed circumferential proximal porous coat applied to the proximal 1/3 of the stem. The middle 1/3 had a roughened blasted textured surface, and the distal 1/3 had a smooth surface. The hydroxyapatite coated femoral stems had an additional hydroxyapatite coating applied to the proximal porous coat with use of an air plasma process. The patients in the two groups were not significantly different regarding age (48.2 +/- 9.0 years hydroxyapatite group, 50.4 +/- 8.7 years control group), gender, Charnley class, or length of followup (4.4 +/- 0.7 years hydroxyapatite group, 4.9 +/- 1.0 years control group). Forty-nine patients (54 hips) were available for clinical followup, and 45 patients (50 hips) had radiographic followup. A minimum 3-year followup was recorded. To date, there have been no femoral prostheses failures. No femoral implant has migrated or subsided. Radiographically, the hydroxyapatite coated stems showed trends toward increased distal stem related cortical hypertrophy, increased cancellous condensation and less endosteal cavitation. Two nonhydroxyapatite coated stems had distal endosteal cavitation, whereas no hydroxyapatite coated stems did. There were two cases of acetabular osteolysis (revision in one) and two cases of acetabular cup migration (nonrevised), all occurring in the control group. The overall revision rate was 4%. There was no difference in Harris hip scores at 6 months (80.6 +/- 13.0 points hydroxyapatite group, 83.8 +/- 12.4 points control group) or at last followup (85.6 +/- 15.4 points hydroxyapatite group, 89.7 +/- 13.4 control group). The Harris hip pain scores also were not significantly different at 6 months or at last followup. Multiple linear regression analysis controlling for age, gender, and length of followup revealed no significant predictors of Harris hip or pain scores. The results of this study at an average of 4.6 years do not indicate a significant clinical advantage to the use of hydroxyapatite coated femoral prostheses in primary cementless total hip arthroplasty when judged by the criteria of Harris hip scores and femoral stem survivorship.

RCT Entities:   Population Interventions Outcomes