Design and development of a contoured ossicular replacement prosthesis: clinical trials of 125 cases.

A columellar ossicular replacement prosthesis has been developed to simplify ossiculoplasties. The hydroxylapatite head has flattened egg-shaped contours set on a teflon shaft. One hundred and twenty-five prostheses have been implanted and the results of eighty-two cases between five and eighteen months' maturity are presented. Sixty-six percent of good risk partial ossicular replacement prosthesis (PORP) cases achieved air-bone closure within ten decibels and eighty-five percent within twenty decibels. Of all total ossicular replacement prosthesis (TORP) and PORP cases, 51.5 percent closed to within ten decibels and 69.5 percent to within twenty decibels. The design has simplified the preparation and implantation techniques and the prosthesis can be used in most ossiculoplasty situations. A malleus handle is not required and interposition of cartilage is unnecessary. The simplicity of the prosthesis should provide particular benefits for the occasional or trainee otologist.