Biocompatibility, bone healing, and safety evaluation in rabbits with an IlluminOss bone stabilization system
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nihms848561.pdf
Description
Accepted version
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3.43 MB
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Author(s) • • • • • • • •
McSweeney, Amanda L.
Zani, Brett G.
Baird, Rose
Stanley, James R. L.
Hayward, Alison
Markham, Peter M.
Kopia, Gregory A.
Rabiner, Robert
Edelman, Elazer R
Date Issued
January 2017
Journal
Journal of Orthopaedic Research
Publisher
Wiley
Citation
McSweeney, Amanda L. et al. "Biocompatibility, bone healing, and safety evaluation in rabbits with an IlluminOss bone stabilization system." Journal of Orthopaedic Research 35,10 (February 2017): 2181–2190 © 2017 Orthopaedic Research Society
Version
Author's final manuscript
Abstract
Bone healing, biocompatibility, and safety employing the IlluminOss System (IS), comprised of an inflatable balloon filled with photopolymerizable liquid monomer, was evaluated in New Zealand white rabbits. Successful bone healing and callus remodeling over 6 months was demonstrated radiologically and histologically with IS implants in fenestrated femoral cortices. Biocompatibility was demonstrated with IS implants in brushed, flushed femoral intramedullary spaces, eliciting no adverse, local, or systemic responses and with similar biocompatibility to K-wires in contralateral femurs up to 1 year post-implant. Lastly simulated clinical failures demonstrated the safety of IS implants up to 1 year in the presence of liquid or polymerized polymer within the intramedullary space. Polymerized material displayed cortical bone and vasculature effects comparable to mechanical disruption of the endosteum. In the clinically unlikely scenario with no remediation or polymerization, a high dose monomer injection resulted in marked necrosis of cortical bone, as well as associated vasculature, endosteum, and bone marrow. Overall, when polymerized and hardened within bone intramedullary spaces, this light curable monomer system may provide a safe and effective method for fracture stabilization. Keywords: fracture stabilization; light‐curable; intramedullary; biocompatibility; polymer
MIT Department
Massachusetts Institute of Technology. Institute for Medical Engineering & Science
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DOI of Published Version
https://doi.org/10.1002/jor.23532