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. 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.

[1]  M. Fontana,et al.  The heat-activated stapes prosthesis 'SMart' Piston: technique and preliminary results. , 2007, Advances in Oto-Rhino-Laryngology.

[2]  A. Eiber,et al.  Tight Stapes Prosthesis Fixation Leads to Better Functional Results in Otosclerosis Surgery , 2008, Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology.

[3]  Mohammed Es-Souni,et al.  Assessing the biocompatibility of NiTi shape memory alloys used for medical applications , 2005, Analytical and bioanalytical chemistry.

[4]  Ugo Fisch,et al.  Tympanoplasty, Mastoidectomy, and Stapes Surgery , 1994 .

[5]  P. van de Heyning,et al.  Systematic Review of the Literature on Nitinol Prostheses in Surgery for Otosclerosis: Assessment of the Adequacy of Statistical Power , 2011, Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology.

[6]  G. Knox,et al.  Shape‐Memory Stapes Prosthesis for Otosclerosis Surgery , 2005, The Laryngoscope.

[7]  Bruce J Gantz,et al.  Hearing results after stapedotomy with a nitinol piston prosthesis. , 2007, Archives of otolaryngology--head & neck surgery.

[8]  S. Gong,et al.  Comparison of Hearing Results of Nitinol SMART Stapes Piston Prosthesis With Conventional Piston Prostheses: Postoperative Results of Nitinol Stapes Prosthesis , 2007, Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology.

[9]  R. Eikelboom,et al.  Eliminating the Limitations of Manual Crimping in Stapes Surgery? A Preliminary Trial with the Shape Memory Nitinol Stapes Piston , 2005, The Laryngoscope.

[10]  G. Schimanski.  Die Arrosion und Nekrose des langen Amboßschenkels nach Otoskleroseoperation , 1997, HNO.

[11]  R. Eikelboom,et al.  Eliminating the Limitations of Manual Crimping in Stapes Surgery: Mid‐Term Results of 90 Patients in the Nitinol Stapes Piston Multicenter Trial , 2007, The Laryngoscope.

[12]  A. Huber,et al.  The influence of postoperative tissue formation on sound transmission after stapes surgery , 2010, Hearing Research.

[13]  J. W. House,et al.  Committee on Hearing and Equilibrium Guidelines for the Evaluation of Results of Treatment of Conductive Hearing Loss ∗ , 1995, Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery.

[14]  Y. Ying,et al.  Patterns of Failure in Heat-Activated Crimping Prosthesis in Stapedotomy , 2011, Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology.

[15]  Robert H Eikelboom,et al.  In vivo performance of the Nitinol shape-memory stapes prosthesis during hearing restoration surgery in otosclerosis: a first report. , 2005, Journal of biomedical materials research. Part B, Applied biomaterials.

[16]  Ugo Fisch,et al.  Intraoperative Assessment of Stapes Movement , 2001, The Annals of otology, rhinology, and laryngology.

[17]  A. Huber,et al.  Biocompatibility of Nitinol Stapes Prosthesis , 2011, Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology.

[18]  T. R. Winch,et al.  Vascular Channels in the Auditory Ossicles in Man , 1974, The Annals of otology, rhinology, and laryngology.

[19]  S. Shabalovskaya,et al.  Surface, corrosion and biocompatibility aspects of Nitinol as an implant material. , 2002, Bio-medical materials and engineering.

[20]  A. Huber,et al.  Stapes Prosthesis Attachment: The Effect of Crimping on Sound Transfer in Otosclerosis Surgery , 2003, The Laryngoscope.

[21]  C. Beatty,et al.  Retrospective Analysis of Outcomes after Stapedotomy with Implantation of a Self-Crimping Nitinol Stapes Prosthesis , 2007, Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery.