title: Response of bone subjected to optimized high dose irradiation.
abstract: Allograft tissues are used in over one million musculoskeletal procedures per year. Consequently, it is crucial tissue banks use procedures to militate against allograft associated bacterial and viral infections. Recent studies have identified an important pathogen inactivation technology for musculoskeletal allografts that utilizes high-dose gamma irradiation (50 kGy) under controlled conditions. A total dose of 50 kGy assures that the current standard for medical devices for a microbial sterility assurance level of 10(- 6) is met. Furthermore, the pathogen inactivation technology results in a greater than four log inactivation of enveloped and nonenveloped viruses. Efficacious clinical outcome from musculoskeletal allografts exposed to this innovative sterilization procedure will require that there is no performance decrement in the allograft's biological properties. Therefore, to validate this objective, we executed a study focusing on remodeling and osteoconduction of bone allografts treated with a high dose of gamma irradiation (50 kGy), radioprotectants and well-defined operating parameters of temperature and water content. A rabbit calvarial model was used to test the hypothesis that remodeling and osteoconduction of allogeneic bone treated with the new pathogen inactivation technology would be equivalent to nontreated allogeneic bone. Results indicated treated bone allografts were comparable to nontreated allografts. We conclude, therefore, that based on this outcome and other reports, that high doses of gamma irradiation under optimized conditions designed to reduce free radical damage to tissue will provide safer allografts.
authors.affiliation: Statseal Inc., 5150 Village Park Drive SE, Suite 110, Bellevue, WA 98006, USA.
authors.forename: H Wilson
authors.initials: HW
authors.lastname: Burgess
authors.forename: James
authors.initials: J
authors.lastname: Mackrell
authors.forename: Derek
authors.initials: D
authors.lastname: Toms
authors.forename: Anuradha
authors.initials: A
authors.lastname: Karunanidhi
authors.forename: Swaroopa
authors.initials: S
authors.lastname: Vaidya
authors.forename: Jeffrey O
authors.initials: JO
authors.lastname: Hollinger
authors.forename: Teri A
authors.initials: TA
authors.lastname: Grieb
authors.forename: Greg P
authors.initials: GP
authors.lastname: Bertenshaw
mesh_terms: D000818:Animals; D001861:Bone Regeneration / Q000528:radiation effects; D016723:Bone Remodeling / Q000528:radiation effects; D016025:Bone Transplantation; D001842:Bone and Bones / Q000382:microbiology / Q000502:physiology / Q000528:radiation effects*; D005260:Female; D005720:Gamma Rays / Q000627:therapeutic use; D006801:Humans; D023421:Models, Animal; D016348:Osseointegration / Q000528:radiation effects; D011817:Rabbits; D011837:Radiation-Protective Agents; D013242:Sterilization / Q000379:methods; D014184:Transplantation, Homologous
chemical_list: D011837:Radiation-Protective Agents