Guiding bone formation in a critical-sized defect and assessments.
OBJECTIVE
Development of alternatives to autologous bone has been served by many hypotheses and developments. Favorable properties of synthetic materials used currently in bone grafting support tissue differentiation without shielding capacity for integrated modeling. Ideally, new materials provide tissue compatibility and minimize patient morbidity and are attractive because of potential for in situ delivery, isothermal polymerization, porous structure, and nontoxic chemistry. For application in cranial bone, ability for materials to be laid adjacent to brain and offer postsurgical protection without neural risk is a critical asset.


METHODS
Kryptonite Bone Cement (KBC) meets the property criteria for cranial bone repair with regard to adhesive, conductive, and biologic transparency and US Food and Drug Administration approval for cranial bone void repair. To better delineate the morphology effective in cranial bone repair, a comparison was made between KBC and BoneSource, another material approved for the same indication. After Institutional Animal Care and Use Committee approval, the study assessed 24 rabbits, each with 2 separate cranial implants, to evaluate integration and absorption of the biomaterial at defined time points of 12, 18, 24, and 36 weeks.


RESULTS
The 36-week assessment demonstrated near-complete resorption/integration of the BoneSource graft material. Bone was present within the biomaterial as well as independent of contact. The KBC was similarly integrated throughout the mass of the material, and new bone was in contact with the grafting material and also seen as separate islands of new bone. The bone demonstrated lamellar bone architecture with clear trabecular morphology. At higher magnification, the bone architecture can be clearly delineated, and comparison between the graft fillers is not obvious relative to the bone that has formed. Despite microscopic similarities, the most striking difference was maintenance of scaffold anatomy during bone regeneration.


CONCLUSIONS
Kryptonite Bone Cement meets the criteria described in the introduction; properties of biologic transparency, osteoconductivity, and ergonomic utility offer other potential uses in bone repair. Key tenets of bone tissue regeneration observed in this analysis included adequate cell differentiation and tissue support. Bone that formed demonstrated lamellar rather than woven bone to suggest response to loading strain rather than merely biochemical precipitation. Over the 36-week study, the graft showed progressive bioabsorbable potential with calibrated replacement.
Doctors Research Group, Southbury, CT, USA.
Joseph
J
Jannetty
Eric
E
Kolb
John
J
Boxberger
Richard
R
Deslauriers
Timothy
T
Ganey
D020341:Absorbable Implants; D000818:Animals; D001672:Biocompatible Materials / Q000737:chemistry / Q000627:therapeutic use; D001843:Bone Cements / Q000737:chemistry / Q000627:therapeutic use; D001847:Bone Diseases / Q000601:surgery*; D001861:Bone Regeneration / Q000502:physiology; D002368:Castor Oil / Q000737:chemistry / Q000627:therapeutic use*; D048091:Guided Tissue Regeneration / Q000379:methods*; D006882:Hydroxyapatites / Q000737:chemistry / Q000627:therapeutic use; D008297:Male; D016348:Osseointegration / Q000502:physiology; D010012:Osteogenesis / Q000502:physiology*; D011108:Polymers / Q000737:chemistry / Q000627:therapeutic use*; D011817:Rabbits; D011897:Random Allocation; D012886:Skull / Q000473:pathology / Q000601:surgery*; D013499:Surface Properties; D013997:Time Factors; D054457:Tissue Scaffolds / Q000737:chemistry
D001672:Biocompatible Materials; D001843:Bone Cements; D006882:Hydroxyapatites; C552291:Kryptonite bone cement; D011108:Polymers; C475044:hydroxyapatite cement; D002368:Castor Oil