OBJECTIVE: To describe a new titanium clip prosthesis for partial ossicular reconstruction with a micro ball joint in the headplate for compensation of tympanic membrane displacements. PATIENTS: Laboratory experiments followed by 18 consecutive patients. INTERVENTIONS: A micro ball joint was implemented into a headplate of titanium middle ear prosthesis. First, the new prosthesis was tested in the laboratory in temporal bone experiments. Second, the new prosthesis was clinically installed in 18 patients. OUTCOME MEASURES: Results of laser Doppler vibrometry and force measurements in the laboratory experiments, analysis of a questionnaire, and preoperative and postoperative pure tone audiometry. RESULTS: The frictional resistance in the joint was measured to be 12 mN that should allow for adequate mobility under physiologic conditions. The effective sound transmission of the prosthesis was demonstrated by laser Doppler vibrometry. Intraoperatively, the installation of the prosthesis was always straightforward with headplate prosthesis shaft angles between 60 and 90 degrees. Postoperatively, pure tone audiometry revealed satisfying hearing results with a remaining average air-bone gap of 18.2 dB over the frequencies 500, 1,000, 2,000, and 3,000 Hz. No signs of prosthesis dislocation were discovered within the follow-up period of approximately 6 months. CONCLUSION: The experimental data show that the new modified prosthesis headplate fulfills the requirements necessary for sound transmission. The joint allows the plate to follow movements of the tympanic membrane. This characteristic in conjunction with the proven clip design ensure for optimal prosthesis placement and effectiveness.
OBJECTIVE: To describe a new titanium clip prosthesis for partial ossicular reconstruction with a micro ball joint in the headplate for compensation of tympanic membrane displacements. PATIENTS: Laboratory experiments followed by 18 consecutive patients. INTERVENTIONS: A micro ball joint was implemented into a headplate of titanium middle ear prosthesis. First, the new prosthesis was tested in the laboratory in temporal bone experiments. Second, the new prosthesis was clinically installed in 18 patients. OUTCOME MEASURES: Results of laser Doppler vibrometry and force measurements in the laboratory experiments, analysis of a questionnaire, and preoperative and postoperative pure tone audiometry. RESULTS: The frictional resistance in the joint was measured to be 12 mN that should allow for adequate mobility under physiologic conditions. The effective sound transmission of the prosthesis was demonstrated by laser Doppler vibrometry. Intraoperatively, the installation of the prosthesis was always straightforward with headplate prosthesis shaft angles between 60 and 90 degrees. Postoperatively, pure tone audiometry revealed satisfying hearing results with a remaining average air-bone gap of 18.2 dB over the frequencies 500, 1,000, 2,000, and 3,000 Hz. No signs of prosthesis dislocation were discovered within the follow-up period of approximately 6 months. CONCLUSION: The experimental data show that the new modified prosthesis headplate fulfills the requirements necessary for sound transmission. The joint allows the plate to follow movements of the tympanic membrane. This characteristic in conjunction with the proven clip design ensure for optimal prosthesis placement and effectiveness.