OBJECTIVE: The aim of this study was to present our experiences and results of stapedotomy performed with and without the piezoelectric device. DESIGN: The article evaluates and compares the use of the piezoelectric device in performing primary stapedotomy in patients affected by otosclerosis with the traditional method of microdrilling. SETTING: The study was conducted with 100 patients in the Department of Otolaryngology of the University of Genoa (Italy), between January 2007 and January 2008. METHODS: A prospective, randomized, controlled trial was undertaken on 100 stapedotomy patients performed using the piezoelectric device (50 patients) or the microdrill (50 patients). MAIN OUTCOME MEASURES: Before surgery and at 1 and 12 months afterward, all patients underwent the following: otomicroscopic evaluation of the external and middle ear, pure-tone audiometry, tympanometry, transient evoked otoacoustic emissions, distortion product otoacoustic emissions, and auditory brainstem response. RESULTS:All patients treated with the piezoelectric device had an air-bone gap reduction, with a closure of the air-bone gap within 10 dB; 44 (88%) patients who underwent traditional surgery had an air-bone gap reduction, with a closure of the air-bone gap within 10 dB. CONCLUSION: All of our postoperative data confirm the safety of the device on the anatomic structures of the middle and inner ear and demonstrate the efficacy of the piezoelectric device in terms of safety, cutting precision, and protection of anatomic structures and its applicability to stapedotomy.
RCT Entities:
OBJECTIVE: The aim of this study was to present our experiences and results of stapedotomy performed with and without the piezoelectric device. DESIGN: The article evaluates and compares the use of the piezoelectric device in performing primary stapedotomy in patients affected by otosclerosis with the traditional method of microdrilling. SETTING: The study was conducted with 100 patients in the Department of Otolaryngology of the University of Genoa (Italy), between January 2007 and January 2008. METHODS: A prospective, randomized, controlled trial was undertaken on 100 stapedotomy patients performed using the piezoelectric device (50 patients) or the microdrill (50 patients). MAIN OUTCOME MEASURES: Before surgery and at 1 and 12 months afterward, all patients underwent the following: otomicroscopic evaluation of the external and middle ear, pure-tone audiometry, tympanometry, transient evoked otoacoustic emissions, distortion product otoacoustic emissions, and auditory brainstem response. RESULTS: All patients treated with the piezoelectric device had an air-bone gap reduction, with a closure of the air-bone gap within 10 dB; 44 (88%) patients who underwent traditional surgery had an air-bone gap reduction, with a closure of the air-bone gap within 10 dB. CONCLUSION: All of our postoperative data confirm the safety of the device on the anatomic structures of the middle and inner ear and demonstrate the efficacy of the piezoelectric device in terms of safety, cutting precision, and protection of anatomic structures and its applicability to stapedotomy.