title: [Stapes surgery for otosclerosis using a new titanium prosthesis with a superelastic nitinol clip: First experiences].
abstract: BACKGROUND
  Coupling of the prosthesis to the long process of the incus is a critical step in stapes surgery. We report first experiences with the NiTiFLEX® stapes prosthesis, a further development of the Soft CliP® stapes prosthesis (Kurz, Dusslingen, Germany). Instead of pure titanium, the CliP® now consists of nitinol, a superelastic nickel-titanium alloy. This further reduces the pressure exerted on the long process of the incus, aiming to improve coupling and minimize the risk of incus luxation.
  
  
  METHODS
  In a monocentric, retrospective cohort study, we evaluated air-bone gap reduction (4PTA0.5-4 kHz), understanding of monosyllables at 65 and 80 dB SPL stimulation levels, and adverse effects, such as changes in bone conduction (4PTA0.5-4 kHz). During a 12-month period (May 2014 to April 2015), stapes surgery was performed in 21 otosclerosis patients using the NiTiFLEX® prosthesis. The footplate was perforated using a CO2 laser (scanning mode; 0.7 mm; 20-21 W) in almost all cases. The diameter of the titan piston was 0.4 mm. Immersion at an angle of almost 90° thus results in a gap between the footplate perforation and the piston of 0.15 mm. Positioning onto the long incus process was performed with a 90°microhook (0.6 mm).
  
  
  RESULTS
  In all cases the NiTiFLEX® stapes prosthesis was inserted without complications. The mean bone conduction threshold did not change significantly postoperatively and the mean air-bone gap (4PTA0.5-4 kHz) improved on average from 29.0 to 9.5 dB HL. Handling of the prosthesis was rated as very good.
  
  
  CONCLUSIONS
  The limited experience of this study suggests that the NiTiFLEX® stapes prosthesis is a successful further development of the Soft CliP® technique with very good intraoperative handling qualities. While long-term results from larger studies are needed, this case series demonstrates that the hearing outcome is comparable to other prostheses.
authors.affiliation: Universitätsklinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie, Martin-Luther-Universität Halle-Wittenberg, Ernst-Grube-Str. 40, 06120, Halle (Saale), Deutschland.
authors.forename: J
authors.initials: J
authors.lastname: Zirkler
authors.affiliation: Universitätsklinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie, Martin-Luther-Universität Halle-Wittenberg, Ernst-Grube-Str. 40, 06120, Halle (Saale), Deutschland.
authors.forename: T
authors.initials: T
authors.lastname: Rahne
authors.affiliation: Universitätsklinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie, Martin-Luther-Universität Halle-Wittenberg, Ernst-Grube-Str. 40, 06120, Halle (Saale), Deutschland. stefan.plontke@uk-halle.de.
authors.forename: S K
authors.initials: SK
authors.lastname: Plontke
mesh_terms: D000328:Adult; D000497:Alloys; D055119:Elastic Modulus; D019544:Equipment Failure Analysis; D005260:Female; D006314:Hearing Loss, Conductive / Q000175:diagnosis / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009998:Ossicular Prosthesis; D019933:Ossicular Replacement / Q000295:instrumentation / Q000379:methods; D010040:Otosclerosis / Q000175:diagnosis / Q000601:surgery*; D010865:Pilot Projects; D011474:Prosthesis Design; D012189:Retrospective Studies; D013201:Stapes Surgery / Q000295:instrumentation* / Q000379:methods; D013525:Surgical Instruments; D014025:Titanium; D016896:Treatment Outcome
chemical_list: D000497:Alloys; C013616:nitinol; D014025:Titanium
keywords: Bone conduction; CO2 lasers; Ossicular replacement; Otologic surgical procedures; Stapes