Je. Dalton et al., THE EFFECT OF OPERATIVE FIT AND HYDROXYAPATITE COATING ON THE MECHANICAL AND BIOLOGICAL RESPONSE TO POROUS IMPLANTS, Journal of bone and joint surgery. American volume, 77A(1), 1995, pp. 97-110
Femoral intramedullary implants were constructed by threading 4.0-mill
imeter-thick disks with a titanium-alloy (Ti-6Al-4V) porous bead coati
ng onto a two-millimeter diameter threaded rod. Each porous-coated dis
k, which was 6.0, 8.0, 9.0, or 10.0 millimeters in diameter, was separ
ated by a two-millimeter-thick acrylic disk with a diameter of ten mil
limeters. Implants with and without a hydroxyapatife coating of twenty
-five micrometers were inserted into fifteen skeletally mature adult m
ongrel dogs. The femoral canal was sequentially reamed bilaterally to
a ten-millimeter diameter, resulting in uniform initial implant-bone i
nterface gaps of 0.0, 0.5, 1.0, and 2.0 millimeters. Each animal recei
ved paired hydroxyapatite-coated and uncoated implants. Three animals
each were killed at four, eight, twelve, twenty-four, and fifty-two we
eks after the implantation. The harvested femora were sectioned throug
h the acrylic spacers, transverse to the long a;bs, to produce individ
ual push-out test specimens for mechanical testing. Characteristics of
interface attachment were determined with test fixtures that supporte
d the surrounding bone to within 150 micrometers of the interface. His
tological sections were prepared, and the amount of bone within the po
rous structure and the amount of the original gap that was filled with
new bone were quantified with a computerized video image-analysis sys
tem. Mechanical attachment strength and bone ingrowth were found to in
crease with the time after implantation and with a decrease in the siz
e of the gap. Placement of the implant in proximal (cancellous) compar
ed with distal (cortical) locations had no significant effect on the s
trength of attachment, bone ingrowth, or gap-filling. However, implant
s with a large initial gap (1.0 or 2.0 millimeters) demonstrated great
er attachment strength in cancellous bone than in cortical bone. With
a few exceptions, hydroxyapatite-coated implants with an initial gap o
f 1.0 millimeter or less demonstrated significantly increased mechanic
al attachment strength and bone ingrowth at all time-periods. Interfac
e attachment strengths were positively correlated with bone ingrowth,
the time after implantation, the use of a hydroxyapatite coating, and
decreasing initial gap size. CLINICAL RELEVANCE: Initial implant-bone
apposition is thought to be a prerequisite for good biological fixatio
n. This apposition is often not achieved because of the design of the
implant or instruments and the operative technique. Poor initial fit d
uring the operation may decrease the longevity of the implant. The res
ults of the present study indicate that attachment strength and bone i
ngrowth are significantly affected by gaps in the interface, particula
rly those of more than 1.0 millimeter. In addition, the use of a hydro
xyapatite coating on the implants was shown to have a positive effect
on fixation of the implant, especially when the initial gap was small.