Department of Orthopaedics and Rehabilitation, Oregon Health and Science University, Portland, OR 97239, USA.
Spine (Phila Pa 1976). 2010 Jul 1;35(15):E702-7. doi: 10.1097/BRS.0b013e3181d2526d.
A standardized questionnaire was directed to medical directors of US structural allograft bone providers regarding their practices in screening potential donors and allograft bone itself for parameters potentially affecting mechanical strength.
To determine the uniformity of practices within the US allograft bone industry regarding parameters related to structural allograft bone mechanical strength.
Despite oversight with respect to disease transmission and contamination, few guidelines exist regarding donor eligibility and bone itself for issues potentially affecting the mechanical integrity of structural allograft bone.
A survey regarding donor and tissue screening practices impacting mechanical strength of structural allograft bone was administered to medical directors of American Association of Tissue Banks-accredited structural allograft bone providers. Results are reported as the percentage of all tissue banks using a given donor or tissue screening method and the percentage of the total US supply of structural allograft bone affected.
Eighty-one percent (14 of 16) of bone-processing banks completed the survey, accounting for 98% of the US supply of structural allograft bone. Approximately 76% (18,712 of 24,671) of all tissue donors are used as a source of structural bone allograft. Thirty-nine percent (6 of 14) of tissue banks have no upper age limit or accept structural allograft bone donors up to age 80. Fifty percent (7 of 14) of banks exclude donors with a diagnosis of osteoporosis. Sixty-four percent (9 of 14) of banks require a minimum cortical dimension of structural bone allograft, representing 81% (15,110 of 18,712) of the US supply. No tissue bank performs dual energy x-ray absorptiometry scans of potential bone donors.
Substantial variability exists in screening practices of US tissue banks regarding mechanical strength of structural allograft bone. Reported variations may reflect the lack of regulatory standards regarding these issues. Further data regarding these variables' impacts on allograft strength and clinical outcomes would be helpful in developing appropriate standards.
向美国结构性同种异体骨供应商的医学主任发放标准化问卷，了解他们在筛选潜在供体和同种异体骨本身时，针对可能影响机械强度的参数的做法。
确定美国同种异体骨行业在与结构性同种异体骨机械强度相关的参数方面的实践是否具有一致性。
尽管对疾病传播和污染进行了监管，但对于供体资格和可能影响结构性同种异体骨机械完整性的骨本身问题，几乎没有指导方针。
向美国组织库协会认证的结构性同种异体骨供应商的医学主任发放了一份关于影响结构性同种异体骨机械强度的供体和组织筛选实践的调查。结果以使用特定供体或组织筛选方法的所有组织库的百分比以及受结构性同种异体骨总供应影响的百分比报告。
81%（16 个中的 14 个）的骨处理库完成了调查，占美国结构性同种异体骨供应的 98%。大约 76%（24671 个中的 18712 个）的所有组织供体都被用作结构性骨同种异体骨的来源。39%（14 个中的 6 个）的组织库没有上限年龄或接受 80 岁以下的结构性同种异体骨供体。50%（14 个中的 7 个）的银行排除骨质疏松症诊断的供体。64%（14 个中的 9 个）的银行要求结构性同种异体骨的最小皮质尺寸，占美国供应的 81%（18712 个中的 15110 个）。没有组织库对潜在骨供体进行双能 X 射线吸收法扫描。
美国组织库在筛选与结构性同种异体骨机械强度相关的供体时，实践存在很大差异。报告的差异可能反映出缺乏这些问题的监管标准。关于这些变量对同种异体骨强度和临床结果的影响的进一步数据将有助于制定适当的标准。
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