Paul F Lachiewicz1, Scott S Kelley, Elizabeth S Soileau. 1. Department of Orthopaedics, University of North Carolina at Chapel Hill, 3151 Bioinformatics Building, CB 7055, 130 Mason Farm Road, Chapel Hill, NC 27514, USA. Paul_Lachiewicz@med.unc.edu
Abstract
BACKGROUND: The optimal surface finish for cemented femoral components remains controversial. The purpose of this randomized clinical trial was to compare the survival of two femoral components with similar geometry but substantially different surface finishes. METHODS: During a five-year period, 201 patients (219 hips) were prospectively randomized to be treated with a total hip arthroplasty with either a polished (Ra, 0.18 to 0.3 microm) or a precoated roughened (Ra, 1.8 to 2.3 microm) cemented femoral component with similar geometry. There were no significant differences between the patient groups in terms of age, sex, weight, preoperative diagnosis, component size, or cement grade. So-called third-generation cementing techniques were used. One hundred and thirteen polished components and 106 precoated roughened components were followed for a mean of 5.3 years. Complete clinical and radiographic data were available for 134 hips at a minimum of five years (mean, 6.1 years; range, five to ten years) postoperatively. RESULTS: In the entire cohort of 219 hips, there was no significant difference (log rank p = 0.66) in survival, with the end point defined as component removal for any reason or definite radiographic loosening, between the precoated components (96.2%; 95% confidence interval, 90.9% to 100%) and the polished components (97.1%; 95% confidence interval, 93.8% to 100%). There was a periprosthetic fracture in three hips with a polished component. Two precoated roughened components were revised because of loosening, and two polished components were revised: one because of loosening and one because of a nonunion of a periprosthetic fracture. There was no significant difference between the groups with regard to the Harris hip scores or the clinical results. There was also no significant difference with regard to the presence or number of bone-cement radiolucent lines. CONCLUSIONS: Kaplan-Meier survival analysis showed no significant differences between two types of cemented femoral components with similar geometry but substantially different surface finishes at seven years. In the patient population selected for treatment with a cemented femoral component, the surface finish may not be a crucial factor affecting component survival at a minimum of five years, provided that good cement technique is used.
RCT Entities:
BACKGROUND: The optimal surface finish for cemented femoral components remains controversial. The purpose of this randomized clinical trial was to compare the survival of two femoral components with similar geometry but substantially different surface finishes. METHODS: During a five-year period, 201 patients (219 hips) were prospectively randomized to be treated with a total hip arthroplasty with either a polished (Ra, 0.18 to 0.3 microm) or a precoated roughened (Ra, 1.8 to 2.3 microm) cemented femoral component with similar geometry. There were no significant differences between the patient groups in terms of age, sex, weight, preoperative diagnosis, component size, or cement grade. So-called third-generation cementing techniques were used. One hundred and thirteen polished components and 106 precoated roughened components were followed for a mean of 5.3 years. Complete clinical and radiographic data were available for 134 hips at a minimum of five years (mean, 6.1 years; range, five to ten years) postoperatively. RESULTS: In the entire cohort of 219 hips, there was no significant difference (log rank p = 0.66) in survival, with the end point defined as component removal for any reason or definite radiographic loosening, between the precoated components (96.2%; 95% confidence interval, 90.9% to 100%) and the polished components (97.1%; 95% confidence interval, 93.8% to 100%). There was a periprosthetic fracture in three hips with a polished component. Two precoated roughened components were revised because of loosening, and two polished components were revised: one because of loosening and one because of a nonunion of a periprosthetic fracture. There was no significant difference between the groups with regard to the Harris hip scores or the clinical results. There was also no significant difference with regard to the presence or number of bone-cement radiolucent lines. CONCLUSIONS: Kaplan-Meier survival analysis showed no significant differences between two types of cemented femoral components with similar geometry but substantially different surface finishes at seven years. In the patient population selected for treatment with a cemented femoral component, the surface finish may not be a crucial factor affecting component survival at a minimum of five years, provided that good cement technique is used.
Authors: Jonathan Hutt; Alexandra Hazlerigg; Ansari Aneel; Geoffrey Epie; Husam Dabis; Roy Twyman; Andrew Cobb Journal: Int Orthop Date: 2014-01-29 Impact factor: 3.075