From June 1997 to June 2003 we performed 194 total hip arthroplasties on 173 patients using alumina ceramic-on-ceramic bearings as part of a prospective United States Food and Drug Administration/Investigational Device Exemption study. The average patient age at surgery was 49.9 years. Minimum followup time was 2 years (mean 4.3 years, range 2-9 years). We evaluated survival rate, implant- and nonimplant-related complications. Clinical outcomes included the Merle d'Aubigné score. We assessed radiographs for signs of osteolysis, component loosening, and implant wear. No patients had osteolysis and there were no hip dislocations. Implant survivorship for all hips with aseptic revision of any component was 96% (CI, 91-100) at 9 year; survivorship for hips without prior surgery was 99.3%, (CI, 98-100). There was a 1.7% incidence of implant-related complications. Our data help confirm two United States FDA/IDE studies on alumina ceramic-on-ceramic total hip arthroplasty that reported low aseptic revision rates and low revision rates for instability. Total hip arthroplasty using alumina ceramic-on-ceramic implants is a safe and reliable procedure in the comparably young and active patient.
Level of Evidence: Level IV, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.
From the Center for Computer Assisted and Reconstructive Surgery, New England Baptist Hospital, Tufts University School of Medicine, Boston, MA.
One or more of the authors (MT, TME) has received funding from of the Swiss National Science Foundation (SNF), and the Research Funding Awards Program of the New England Baptist Hospital.
Each author certifies that his institution has approved the human protocol for this investigation and that all investigations were conducted in conformity with ethical principles of research, and that informed consent was obtained.
Correspondence to: Stephen B. Murphy, MD, Center for Computer Assisted and Reconstructive Surgery, Tufts University School of Medicine, 125 Parker Hill Avenue, Suite 545, Boston, MA 02120. Phone: 617-232-3040; Fax: 617-754-6436; E-mail: firstname.lastname@example.org.