A Universal Ossicular Replacement Prosthesis: Clinical Trials of 152 Cases

Abstract

An ossicular replacement prosthesis is described that advances implant design in several respects. The head is a flattened egg shape, which eliminates pressure points against the pars tensa and provides balance on the stapes. Dense hydroxylapatite ceramic provides maximal biocompatibility. The shaft, of either Teflon or Plastipore, is easily cut to size and is replaceable to minimize wastage. Interchangeable partial or total shaft variants are provided. Trials in more than 200 patients have produced optimal results. Among 152 mature patients in 85% of the good-risk cases, the air-bone gap closed to within 20 dB and in 65% to within 10 dB; in 69% of all cases the gap closed to within 20 dB. Extrusion rates were 5% in good-risk cases and 7% overall. Long-term extrusions have not occurred. Inasmuch as cartilage interpositioning is unnecessary, the prosthesis is rapidly prepared and implanted by an easily mastered technique.