Promising clinical results of an innovative self-crimping stapes prosthesis in otosclerosis surgery

Abstract

Objectives: This clinical study was performed to retrospectively analyze the hearing improvement of patients with otosclerosis who underwent stapesplasty with a novel nitinol prosthesis in comparison with the use of already established prostheses (titanium and clip prostheses) and to evaluate the suitability of the nitinol prosthesis for ear surgeons with limited experience in otosclerosis surgery.

Study design: Retrospective data analysis.

Setting: Tertiary referral center.

Patients: Sixty patients who underwent otosclerosis surgery between July 1, 2010, and June 30, 2012, in the ENT department of the University of Munich. Two patients were operated on both sides. For four patients, the stapesplasty was a revision surgery.

Interventions: Sixty-two procedures of otosclerosis surgery were performed by 6 ear surgeons, one of whom with profound experience in stapesplasty.

Main outcome measures: 1) Postoperative air-bone gap, determined for all surgeons together as well as itemized for the experienced and the nonexperienced stapes surgeons; 2) closure of the air-bone gap in 10 dB bins; and 3) change of high-tone bone-conduction level.

Results: Pure-tone audiometry documented less postoperative air-bone gap and a higher percentage of air-bone gap closure when using the nitinol prosthesis, especially in comparison with the clip prosthesis. Also, nonexperienced stapes surgeons received better audiometric results when using the novel nitinol prosthesis.

Conclusions: Clinical evaluation suggests the novel nitinol prosthesis to be a promising tool in otosclerosis surgery for experienced stapes surgeons as well as for ear surgeons with limited experience in stapes surgery.