K. Thoren et P. Aspenberg, ETHYLENE-OXIDE STERILIZATION IMPAIRS ALLOGRAFT INCORPORATION IN A CONDUCTION CHAMBER, Clinical orthopaedics and related research, (318), 1995, pp. 259-264
Bone allograft processing often includes treatment with hydrogen perox
ide for protein denaturation and sterilization by irradiation or ethyl
ene oxide, The effect of these treatments on the osteoconductive prope
rties of the graft was tested by measuring the new bone ingrowth dista
nce into processed cancellous bone grafts in rats, Forty graft pairs w
ere taken from rat tibias, and were frozen, defatted in chloroform-met
hanol, and dried, In addition, 1 graft of each pair was treated with 2
% hydrogen peroxide, 2.5 Mrad irradiation, or by a Steri-Vac hospital
ethylene oxide chamber, The grafts were placed in bone conduction cham
bers and implanted in rat tibias, Six weeks after implantation, the ch
ambers were emptied, and the new bone ingrowth distance and scintimetr
ic activity were measured, Ethylene oxide treatment impaired the new b
one ingrowth distance by 68% and reduced the scintimetric activity by
51%. Another 10 defatted grafts, which had been ethylene oxide treated
together with the grafts for implantation, were analyzed for levels o
f residual ethylene oxide, ethylene chlorohydrin, and ethylene glycol,
Ail the measured residuals were below the detection limit of 20 parts
per million, which was below the level recommended by the United Stat
es Food and Drug Administration, Ethylene oxide sterilization was more
deleterious for bone allografts than expected.