title: The biologic response to particles from a lumbar disc prosthesis.
abstract: METHODS
  Particles of a proprietary polyolefin rubber compound used in a lumbar disc prosthesis were generated in vitro and tested for biocompatibility in two animal models. OBJECTIVE To characterize any tissue response to polyolefin rubber particles.
  
  
  BACKGROUND
  Intervertebral disc prostheses are emerging as alternatives to fusion techniques for the treatment of symptomatic disc degeneration. The biocompatibility of all novel components used in the construction of these devices must be verified before they can be considered for general use.
  
  
  METHODS
  Laboratory-generated polyolefin rubber particles were either injected into dorsal subcutaneous air pouches of 30 rats or placed directly onto the lumbosacral dura and nerve roots of 9 sheep. Histologic sections of tissues from, and remote from, the site of implantation were examined for evidence of inflammation and wound-healing responses.
  
  
  RESULTS
  Polyolefin rubber particle debris induced a tissue response that was consistent with a normal foreign body reaction to large particles. The response was not significantly greater than that seen with similar size particles of ultrahigh molecular weight polyethylene. There was no evidence of particle migration from the site of implantation, and there was no evidence of local or systemic toxic effects.
  
  
  CONCLUSIONS
  Polyolefin rubber particles induce only localized tissue response that is consistent with a normal foreign body reaction to large nontoxic particles.
authors.affiliation: Adelaide Centre for Spinal Research, Institute of Medical and Veterinary Science, Department of Pathology, Adelaide University, Australia. rob.moore@imvs.sa.gov.au
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Moore
authors.forename: Robert D
authors.initials: RD
authors.lastname: Fraser
authors.forename: Barrie
authors.initials: B
authors.lastname: Vernon-Roberts
authors.forename: John W
authors.initials: JW
authors.lastname: Finnie
authors.forename: Peter C
authors.initials: PC
authors.lastname: Blumbergs
authors.forename: David R
authors.initials: DR
authors.lastname: Haynes
authors.forename: Martin J
authors.initials: MJ
authors.lastname: Hutchens
authors.forename: Rebecca M
authors.initials: RM
authors.lastname: Walters
authors.forename: Anant S
authors.initials: AS
authors.lastname: Kamat
authors.forename: Barbara
authors.initials: B
authors.lastname: Koszyca
mesh_terms: D000818:Animals; D062109:Dermatologic Surgical Procedures; D004333:Drug Administration Routes; D004388:Dura Mater / Q000187:drug effects / Q000473:pathology; D004868:Equipment Failure / Q000706:statistics & numerical data*; D019544:Equipment Failure Analysis; D005549:Foreign-Body Reaction / Q000209:etiology* / Q000473:pathology; D020007:Implants, Experimental / Q000009:adverse effects* / Q000706:statistics & numerical data; D007403:Intervertebral Disc / Q000601:surgery; D007405:Intervertebral Disc Displacement / Q000209:etiology / Q000601:surgery; D007796:Laminectomy; D008161:Lumbosacral Region; D008297:Male; D008422:Materials Testing / Q000706:statistics & numerical data*; D008863:Microspheres; D023421:Models, Animal; D010316:Particle Size; D011090:Polyenes / Q000737:chemistry / Q000494:pharmacology; D011095:Polyethylenes / Q000737:chemistry / Q000494:pharmacology; D051381:Rats; D011919:Rats, Inbred Strains; D012408:Rubber / Q000737:chemistry / Q000494:pharmacology; D012756:Sheep; D012867:Skin / Q000473:pathology; D013126:Spinal Nerve Roots / Q000187:drug effects / Q000473:pathology
chemical_list: D011090:Polyenes; D011095:Polyethylenes; C111601:ultra-high molecular weight polyethylene; C035051:PL 732; D012408:Rubber