title: A new adhesive bonding material for the cementation of implantable devices in otologic surgery.
abstract: BACKGROUND
  Presently, there are no U.S. Food and Drug Administration (FDA)-approved adhesive bone cements for the surgical fixation of prosthetic materials in the middle ear. A promising new cement, 4-META/MMA-TBB opaque resin, has shown remarkable adhesive properties as a bone cement in vivo. The cement is composed of 4-methacryloyloxyethyl trimellitate anhydride (4-META) and methyl methacrylate (MMA) as monomers and tri-n-butyl borane (TBB) as an initiator.
  
  
  METHODS
  An electromagnetic semiimplantable hearing device presently under development was implanted into the middle ear of six cats using 4-META/MMA-TBB resin to cement a titanium-encased magnet to the incus. The animals were subsequently killed (at a mean of 9.6 months) to assess the (temporal bones and specifically the magnet-incus complex in each animal.
  
  
  RESULTS
  The titanium-encapsulated magnet was firmly adherent to all incuses without any failure of the cement-bone interface. Histopathologic examination of the implanted temporal bones demonstrated lack of middle ear inflammation. Transmission electron microscopy of the incuses demonstrated a unique "hybrid layer" in the bone-side subsurface of the bone-cement interface that elucidates the mechanism of interfacial adhesion.
  
  
  CONCLUSIONS
  Our investigation highlights the special biomechanical properties as well as the biocompatibility of 4-META/ MMA-TBB resin that make it an attractive bone-bonding agent for use in otologic surgery, including its potential usefulness during ossicular reconstruction.
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, Case Western Reserve University, University Hospitals of Cleveland, Ohïo 44106-5045, USA.
authors.forename: A J
authors.initials: AJ
authors.lastname: Maniglia
authors.forename: N
authors.initials: N
authors.lastname: Nakabayashi
authors.forename: M M
authors.initials: MM
authors.lastname: Paparella
authors.forename: J W
authors.initials: JW
authors.lastname: Werning
mesh_terms: D000818:Animals; D002415:Cats; D002484:Cementation; D004423:Ear / Q000601:surgery*; D004429:Ear Ossicles / Q000601:surgery; D013701:Temporal Bone / Q000648:ultrastructure; D014014:Tissue Adhesives
chemical_list: D014014:Tissue Adhesives