The biologic response to particles from a lumbar disc prosthesis.
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.
Moore
Robert J
RJ
Adelaide Centre for Spinal Research, Institute of Medical and Veterinary Science, Department of Pathology, Adelaide University, Australia. rob.moore@imvs.sa.gov.au
Fraser
Robert D
RD
Vernon-Roberts
Barrie
B
Finnie
John W
JW
Blumbergs
Peter C
PC
Haynes
David R
DR
Hutchens
Martin J
MJ
Walters
Rebecca M
RM
Kamat
Anant S
AS
Koszyca
Barbara
B
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
D011090:Polyenes; D011095:Polyethylenes; C111601:ultra-high molecular weight polyethylene; C035051:PL 732; D012408:Rubber