Biocompatibility of nitinol stapes prosthesis.
- 2010-12-15
Published in:
- Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology. - 2011
Adult
Alloys
Biocompatible Materials
Cochlear Implantation
Ear Canal
Ear, Middle
Female
Humans
Incus
Male
Materials Testing
Microscopy, Electron, Scanning
Middle Aged
Mucous Membrane
Nickel
Ossicular Prosthesis
Spectrophotometry, Atomic
Stapes Surgery
English
OBJECTIVE
Use of the SMart piston, a nitinol-based, self-crimping prosthesis in stapes surgery may allow improved functional results because of better sound transmission properties at the incus-prosthesis interface because of the elimination of manual crimping. Possible disadvantages include thermal damage or strangulation of the incus and its mucoperiosteum or nickel intolerance. The goal of this study was to morphologically assess the fixation of this prosthesis to the incus, investigate the reaction of the middle ear mucosa to the prosthesis, identify alterations to the incudal bone, and detect deposits of nickel in the tissue around the prosthesis.
STUDY DESIGN
Prospective consecutive case analysis.
SETTING
Tertiary referral center.
PATIENTS
Four patients with an unfavorable functional result after primary SMart-piston stapedotomy.
INTERVENTION
Revision malleostapedotomy with explantation of the incus and prosthesis for further analysis.
MAIN OUTCOME MEASURES
Analysis of intraoperative findings and postoperative examination of the explants using light- and scanning-electron microscopy, energy dispersive x-ray analysis, and atom absorption spectrometry.
RESULTS
The intraoperative, macroscopic, and scanning electron microscopic investigation showed tight circular fixation of the prostheses, whereas a gap between the prosthesis and the lateral incus was found in 1 case. All prostheses were overgrown by mucosa. Superficial localized erosion of the incudal bone was found in 2 cases. There was no elevation in nickel content in the removed tissue samples.
CONCLUSION
The lateral gap between prosthesis and incus did not affect fixation of the prosthesis, neither did covering by a mucosal layer. Bone erosion was most likely caused by laser in one and by the prosthesis in another explant. No signs of increased nickel deposits could be found on energy dispersive x-ray analysis or atom absorption spectrometry. We conclude that a nitinol stapes prosthesis is safe for treatment of stapedial fixation.
Use of the SMart piston, a nitinol-based, self-crimping prosthesis in stapes surgery may allow improved functional results because of better sound transmission properties at the incus-prosthesis interface because of the elimination of manual crimping. Possible disadvantages include thermal damage or strangulation of the incus and its mucoperiosteum or nickel intolerance. The goal of this study was to morphologically assess the fixation of this prosthesis to the incus, investigate the reaction of the middle ear mucosa to the prosthesis, identify alterations to the incudal bone, and detect deposits of nickel in the tissue around the prosthesis.
STUDY DESIGN
Prospective consecutive case analysis.
SETTING
Tertiary referral center.
PATIENTS
Four patients with an unfavorable functional result after primary SMart-piston stapedotomy.
INTERVENTION
Revision malleostapedotomy with explantation of the incus and prosthesis for further analysis.
MAIN OUTCOME MEASURES
Analysis of intraoperative findings and postoperative examination of the explants using light- and scanning-electron microscopy, energy dispersive x-ray analysis, and atom absorption spectrometry.
RESULTS
The intraoperative, macroscopic, and scanning electron microscopic investigation showed tight circular fixation of the prostheses, whereas a gap between the prosthesis and the lateral incus was found in 1 case. All prostheses were overgrown by mucosa. Superficial localized erosion of the incudal bone was found in 2 cases. There was no elevation in nickel content in the removed tissue samples.
CONCLUSION
The lateral gap between prosthesis and incus did not affect fixation of the prosthesis, neither did covering by a mucosal layer. Bone erosion was most likely caused by laser in one and by the prosthesis in another explant. No signs of increased nickel deposits could be found on energy dispersive x-ray analysis or atom absorption spectrometry. We conclude that a nitinol stapes prosthesis is safe for treatment of stapedial fixation.
- Language
-
- English
- Open access status
- green
- Identifiers
-
- DOI 10.1097/MAO.0b013e318201622e
- PMID 21150688
- Persistent URL
- https://sonar.ch/global/documents/141712
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