Clinical evaluation of the NiTiBOND stapes prosthesis, an optimized shape memory alloy design.
OBJECTIVE
To prospectively analyze short-term (3 mo) results in patients with otosclerosis who underwent stapedotomy with the newly designed NiTiBOND prosthesis and compare them with patients that underwent SMart piston stapedotomy. We aimed to assess "noninferiority" for the new prosthesis.


METHODS
Prospective controlled trial.


METHODS
Tertiary referral center.


METHODS
Thirty-eight patients were included in the NiTiBOND group (41 ears), and 74 patients were included in the SMart Piston group (75 ears).


METHODS
Stapedotomy.


METHODS
Pure-tone audiometry 3 months after surgery, intraoperative prosthesis handling as assessed using a questionnaire, and complications were analyzed.


RESULTS
Pure-tone audiometry showed postoperative air-bone gap means (standard deviation) of 8.1 (8.3) and 9.9 (5.4) dB; air-bone gap closure within 10 dB was achieved in 71% and 72% and within 20 dB in 93% and 96% for the NiTiBOND and the SMart piston prosthesis, respectively. Noninferiority was shown at all frequencies and in the pure-tone average. The NiTiBOND prosthesis provides excellent intraoperative handling, and no adverse reactions were reported.


CONCLUSIONS
Preliminary short-term results suggest safety and reliability for the new NiTiBOND stapes prosthesis.
Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital of Zurich, Zurich, Switzerland. alex.huber@usz.ch
Alexander M
AM
Huber
Thomas
T
Schrepfer
Albrecht
A
Eiber
D000328:Adult; D000368:Aged; D000497:Alloys; D000758:Anesthesia; D001301:Audiometry, Pure-Tone; D001309:Auditory Threshold / Q000502:physiology; D001672:Biocompatible Materials; D004867:Equipment Design / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016343:Monitoring, Intraoperative / Q000379:methods; D009998:Ossicular Prosthesis; D010040:Otosclerosis / Q000601:surgery; D017060:Patient Satisfaction; D011446:Prospective Studies; D013067:Speech Perception / Q000502:physiology; D013201:Stapes Surgery; D011795:Surveys and Questionnaires; D014025:Titanium; D016896:Treatment Outcome; D055815:Young Adult
D000497:Alloys; D001672:Biocompatible Materials; C013616:nitinol; D014025:Titanium