title: [NiTiBOND an optimized self-crimping stapes prosthesis for treatment of otosclerosis].
abstract: BACKGROUND
  Compared to traditional stapes prostheses, self-crimping prostheses have been shown to result in similar, if not better, closure of the air bone gap in patients undergoing stapedotomy for otosclerosis. To achieve self-crimping, nitinol, a shape memory alloy, has been used for several years but concerns have been raised regarding possible damage to the incus and its muco-periosteum. We investigate these concerns with regard to the newer NiTiBOND stapes prosthesis in an observational multi-centre study.
  
  
  METHODS
  In a multicentre, prospective observational study, 76 patients undergoing stapedotomy with the NiTiBond prosthesis across 4 centres were compared to 75 -retrospectively selected control SMart patients. Complications, intra-operative user-friendliness and audiological results at 3 months were documented.
  
  
  RESULTS
  Audiological improvement and the rate of complications were similar in both groups. Non inferiority was shown at all frequencies and in the pure-tone average. The NiTiBOND prosthesis was described as very user-friendly.
  
  
  CONCLUSIONS
  By eliminating manual crimping, stapedotomy using the NiTiBOND prosthesis can be facilitated and standardized. Furthermore, intraoperative handling characteristics of the prosthesis are very good which may further reduce operative risk. Importantly, we show that these benefits are not to the detriment of audiological outcome. Larger and longer-term studies are required to further evaluate results.
authors.affiliation: Klinik für Ohren-, Nasen-, Hals- und Gesichtschirurgie, Universitätsspital Zürich, Schweiz.
authors.forename: A M
authors.initials: AM
authors.lastname: Huber
authors.affiliation: HNO-Klinik, Kopf- und Halschirurgie, Universität Erlangen-Nürnberg, Erlangen.
authors.forename: J
authors.initials: J
authors.lastname: Hornung
authors.affiliation: Universitätsklinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie, Universitätsklinikum Halle (Saale).
authors.forename: S
authors.initials: S
authors.lastname: Plontke
authors.affiliation: Klinik für Ohren-, Nasen-, Hals- und Gesichtschirurgie, Universitätsspital Zürich, Schweiz.
authors.forename: C
authors.initials: C
authors.lastname: Röösli
authors.affiliation: HNO-Klinik, Kopf- und Halschirurgie, Universität Erlangen-Nürnberg, Erlangen.
authors.forename: H
authors.initials: H
authors.lastname: Iro
authors.affiliation: HNO-Klinik, Universitätsklinik Regensburg.
authors.forename: J
authors.initials: J
authors.lastname: Strutz
authors.affiliation: Universitätsklinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie, Universitätsklinikum Halle (Saale).
authors.forename: T
authors.initials: T
authors.lastname: Rahne
authors.affiliation: Klinik für Ohren-, Nasen-, Hals- und Gesichtschirurgie, Universitätsspital Zürich, Schweiz.
authors.forename: T F
authors.initials: TF
authors.lastname: Pezier
authors.affiliation: HNO-Klinik, Universitätsklinik Regensburg.
authors.forename: P
authors.initials: P
authors.lastname: Kwok
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000497:Alloys; D001301:Audiometry, Pure-Tone; D001309:Auditory Threshold; D001844:Bone Conduction; D002648:Child; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009998:Ossicular Prosthesis; D010040:Otosclerosis / Q000601:surgery*; D011474:Prosthesis Design; D012189:Retrospective Studies; D014025:Titanium; D055815:Young Adult
chemical_list: D000497:Alloys; C013616:nitinol; D014025:Titanium