Biomedical Engineering Reference
In-Depth Information
3.
Bone Allograft Safety and Performance
Calin S. Moucha, Regis L. Renard, Ankur Gandhi,
Sheldon S. Lin, and Rocky S. Tuan
3.1 Introduction
3.2 An Overview of
Musculoskeletal Graft
Harvesting and Processing
Bone allograft transplantation is a common
practice; in the United States
650
,
000
proce-
dures were performed in
1999
, a
186
% increase
from
]. This increase can be attributed
to morbidities associated with bone autografts
[
1990
[
3
In the United States, the Food and Drug Admin-
istration (FDA) currently regulates organ and
tissue transplants with mandated donor and
tissue screening protocols for human immuno-
defi ciency virus (HIV) types
], the increased availability of
bone allografts, and the expansion of these
applications [
6
,
18
,
30
,
35
,
59
]. A
variety of musculoskeletal allografts are avail-
able for different reconstructive applications.
Bone allograft is an alternative to autograft
because it has osteoconductive properties, acts
as a scaffold for bone growth, and induces bone
formation by providing osteogenic factors, in
addition to mesenchymal precursor cells,
osteoblasts, and osteocytes. Although these
properties are advantageous, the potential for
the transmission of infectious diseases remains
a great concern [
9
,
16
,
21
,
22
,
29
,
31
,
42
,
66
, hepatitis
B virus (HBV), and hepatitis C virus (HCV)
(Table
1
and
2
). The FDA also requires documenta-
tion to accompany the donor graft to provide a
medical history that precludes any recent infec-
tions or patient “social” habits, such as drug
abuse, which would increase the risk of allograft
infection. In addition, the American Associa-
tion of Tissue Banks (AATB), a nonprofi t orga-
nization, provides industry guidelines and
recommendations for its accredited members
beyond those of the FDA, which include testing
for human T-lymphocytic virus (HTLV) types
1
3
.
1
1
,
2
,
4
,
10
,
12
,
24
,
26
,
27
,
32
,
38
,
49
]. Because of the biological origin of bone
allografts, the clinician must be educated about
the effects of tissue preparation and processing
on the immunogenic, osteoinductive, osteo-
conductive, and structural properties of
allografts in order to make appropriate clinical
decisions. This chapter discusses the safety of
bone allografts and the effects of donor selec-
tion, harvesting, processing, and implantation
on the performance of bone allograft in recon-
structive surgery.
,
53
). However,
there are no uniform industry standards for
tissue processing, and not all tissue banks are
AATB-accredited. Medical conditions contra-
indicated by the FDA and AATB for tissue and
organ donation include benign tumors near the
allograft excision sites, malignant tumors,
autoimmune or infl ammatory diseases, severe
endocrine/metabolic disease, and collagen dis-
eases [
and
2
and syphilis [
67
] (Table
3
.
1
22
,
29
,
36
,
42
,
62
,
63
]. Additional contra-
46
