Study Design. 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.
Objective. To determine the uniformity of practices within the US allograft bone industry regarding parameters related to structural allograft bone mechanical strength.
Summary of Background Data. 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.
Methods. 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.
Results. 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.
Conclusion. 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.
This article reports the results of a questionnaire directed to medical directors of US tissue banks regarding their practices in screening potential donors and assessing other factors relating to the mechanical strength of structural human bone allograft. The results of the study suggest that a number of different approaches to these issues are currently used by various allograft bone providers. Whether these variations have clinical significance has not been demonstrated and will require further biomechanical and clinical studies.
From the Department of Orthopaedics and Rehabilitation, Oregon Health and Science University, Portland, OR.
Acknowledgment date: April 23, 2009. Revision date: August 23, 2009. Acceptance date: December 15, 2009.
The manuscript submitted does not contain information about medical device(s)/drug(s).
No funds were received in support of this work. No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript.
Address correspondence and reprint requests to Robert Hart, MD, Department of Orthopaedics and Rehabilitation, Oregon Health and Science University, 3181 SW Sam Jackson Park Rd., 0P31, Portland, OR 97239; E-mail: email@example.com