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Clinical Evaluation of the NiTiBOND Stapes Prosthesis, an Optimized Shape Memory Alloy Design.
MedLine Citation:
PMID:  22215449     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
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.
Authors:
Alexander M Huber; Thomas Schrepfer; Albrecht Eiber
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-12-30
Journal Detail:
Title:  Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology     Volume:  -     ISSN:  1537-4505     ISO Abbreviation:  -     Publication Date:  2011 Dec 
Date Detail:
Created Date:  2012-1-4     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100961504     Medline TA:  Otol Neurotol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
*Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital of Zurich, Zurich, Switzerland; and †Institute of Engineering and Computational Mechanics, University of Stuttgart, Stuttgart, Germany.
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