A592. CLINICAL RESULTS OF CERAMIC/ CERAMIC IN THR

Abstract

At ten years, alumina ceramic bearings are functioning well with low complication rates and a fewer number of revisions than the control cohort.

Alumina ceramic bearings have proven superior wear resistance, lubrication, and scratch resistance, without carrying the risk of metal ion release. In 1996 a U.S. IDE clinical trial was initiated utilizing newly improved alumina ceramic materials and implant design. The purpose of this multi-center, prospective, randomized study is to prove comparable safety and efficacy of alumina-alumina ceramic to a control cobalt chrome-polyethylene bearing.

Four hundred fifty two patients (475 hips) are followed in this study. Subjects include ceramic on ceramic, with either porous coated cup or arc deposited cup, or control group with metal on polyethylene with porous coated cup. Average age of subject at time of surgery was 53 years with 82% diagnosis of OA. The average Harris Hip Score was 96 and 94% of hips had little to no pain. Kaplan-Maier survivorship at 10 years, component revision for any reason, was 95.9% for ceramic bearings compared to 91.3% for metal on polyethylene control. There have been nine hips requiring revision of one or both components for any reason.

Data was recently collected on the subjects that participated in either the IDE or Continued Access arms of the ABC^® and Trident^® study. Data collection included revisions, complications, and noise. Out of 930 hips (848 patients) there were nine incidences of squeaking noise reported, no wear/osteolysis issues, and only two insert fractures (0.2%).

At ten years ceramic bearings show no wear, inconsequential lysis, minimal breakage, and occasion noise. Clinically, alumina ceramic bearings perform as well as the metal-on-polyethylene, with fewer revisions and less osteolysis, suggesting that they are a safe, viable option for younger, more active patients.