title: Biocompatibility, bone healing, and safety evaluation in rabbits with an IlluminOss bone stabilization system.
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. © 2017 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 35:2181-2190, 2017.
authors.affiliation: Concord Biomedical Sciences and Emerging Technologies, 500 Shire Way, Lexington, Massachusetts 02421.
authors.forename: Amanda L
authors.initials: AL
authors.lastname: McSweeney
authors.affiliation: Concord Biomedical Sciences and Emerging Technologies, 500 Shire Way, Lexington, Massachusetts 02421.
authors.forename: Brett G
authors.initials: BG
authors.lastname: Zani
authors.affiliation: Concord Biomedical Sciences and Emerging Technologies, 500 Shire Way, Lexington, Massachusetts 02421.
authors.forename: Rose
authors.initials: R
authors.lastname: Baird
authors.affiliation: Concord Biomedical Sciences and Emerging Technologies, 500 Shire Way, Lexington, Massachusetts 02421.
authors.forename: James R L
authors.initials: JRL
authors.lastname: Stanley
authors.affiliation: Concord Biomedical Sciences and Emerging Technologies, 500 Shire Way, Lexington, Massachusetts 02421.
authors.forename: Alison
authors.initials: A
authors.lastname: Hayward
authors.affiliation: Concord Biomedical Sciences and Emerging Technologies, 500 Shire Way, Lexington, Massachusetts 02421.
authors.forename: Peter M
authors.initials: PM
authors.lastname: Markham
authors.affiliation: Kopia Consulting, 61-4D Taurus Drive Hillsborough, Hillsborough, New Jersey 08844.
authors.forename: Gregory A
authors.initials: GA
authors.lastname: Kopia
authors.affiliation: Institute for Medical and Engineering Science, Massachusetts Institute of Technology, E25, 45 Carleton Street, Cambridge, Massachusetts 02139.
authors.forename: Elazer R
authors.initials: ER
authors.lastname: Edelman
authors.affiliation: IlluminOss Medical Inc., 993 Waterman Avenue, East Providence, Rhode Island 02914.
authors.forename: Robert
authors.initials: R
authors.lastname: Rabiner
mesh_terms: D000818:Animals; D005260:Female; D005264:Femoral Fractures / Q000628:therapy*; D005593:Fracture Fixation, Internal / Q000295:instrumentation*; D017102:Fracture Healing; D008422:Materials Testing; D019060:Minimally Invasive Surgical Procedures; D011817:Rabbits
keywords: biocompatibility; fracture stabilization; intramedullary; light-curable; polymer