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CBER - Human Bone Allograft: Manipulation and Homologous Use in Spine and Other Orthopedic Reconstruction and Repair |
 | | Grogen, in 1999, showed the use of allograft bone in scoliosis surgery and demonstrated this bone among 87 adolescent patients to be safe, reliable, an effective option, and found comparable results and clinical outcomes when compared to autograft bone. |
 | | So, to begin to try to differentiate between allograft and autograft, as it is used particularly in the lumbar spine for either structural support or a lattice for bone to grow through, I think is an artificial definition, and the one that we probably need to try to get away from a little bit. |
 | | First of all, for age, does the age of the donor affect the allograft, and there is a wide range of age that is accepted, and are there any thoughts taken into account in terms of the age range, in terms of the patients that are selected. |
| www.fda.gov /Cber/minutes/opm080200.htm (17307 words) |
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