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Clinical Evaluation of the NiTiBOND Stapes Prosthesis, an Optimized Shape Memory Alloy Design


Huber, A M; Schrepfer, T; Eiber, A (2012). Clinical Evaluation of the NiTiBOND Stapes Prosthesis, an Optimized Shape Memory Alloy Design. Otology and Neurotology, 33(2):132-6.

Abstract

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.

STUDY DESIGN: Prospective controlled trial.

SETTING: Tertiary referral center.

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

INTERVENTION(S): Stapedotomy.

MAIN OUTCOME MEASURE(S): 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.

CONCLUSION: Preliminary short-term results suggest safety and reliability for the new NiTiBOND stapes prosthesis.

Abstract

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.

STUDY DESIGN: Prospective controlled trial.

SETTING: Tertiary referral center.

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

INTERVENTION(S): Stapedotomy.

MAIN OUTCOME MEASURE(S): 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.

CONCLUSION: Preliminary short-term results suggest safety and reliability for the new NiTiBOND stapes prosthesis.

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10 citations in Web of Science®
12 citations in Scopus®
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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Clinic for Otorhinolaryngology
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:2012
Deposited On:26 Jan 2012 15:41
Last Modified:05 Apr 2016 15:30
Publisher:Lippincott Wiliams & Wilkins
ISSN:1531-7129
Publisher DOI:https://doi.org/10.1097/MAO.0b013e31823e28cb
PubMed ID:22215449

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