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e have studied the characteristics of bone This porous tantalum biomaterial has desirable
W ingrowth of a new porous tantalum biomaterial
in a simple transcortical canine model using
characteristics for bone ingrowth; further studies are
warranted to ascertain its potential for clinical
cylindrical implants 510 mm in size. The material reconstructive orthopaedics.
was 75% to 80% porous by volume and had a J Bone Joint Surg [Br] 1999;81-B:907-14.
repeating arrangement of slender interconnecting Received 9 July 1998; Accepted after revision 5 March 1999
struts which formed a regular array of
dodecahedron-shaped pores. We performed
histological studies on two types of material, one with In the last 20 years a variety of porous surfaces and
a smaller pore size averaging 430 µm at 4, 16 and 52 materials has been used to obtain fixation of bone ingrowth
weeks and the other with a larger pore size averaging in total hip and knee prostheses. The most common include
650 µm at 2, 3, 4, 16 and 52 weeks. Mechanical titanium and cobalt-chrome-alloy sintered beads, diffusion-
1-8
push-out tests at 4 and 16 weeks were used to assess bonded titanium, fibre metal, and titanium plasma spray.
the shear strength of the bone-implant interface on Based on the clinical outcome and histological evidence
implants of the smaller pore size. from retrieved implants, it is clear that porous surfaces
The extent of filling of the pores of the tantalum support tissue ingrowth or ongrowth and are generally
material with new bone increased from 13% at two effective for supplementing the stability of the implant by
9-15
weeks to between 42% and 53% at four weeks. By 16 biological fixation.
and 52 weeks the average extent of bone ingrowth Nevertheless, conventional porous materials each have
ranged from 63% to 80%. The tissue response to the certain deficiencies or weaknesses. For instance, sintered
small and large pore sizes was similar, with regions of beaded and fibre metal coatings have a porosity which is
contact between bone and implant increasing with limited to 30% to 50% by volume, a factor which directly
time and with evidence of Haversian remodelling limits the maximum interfacial strength that can develop by
within the pores at later periods. Mechanical tests at bone ingrowth. Conventional metallic porous materials are
four weeks indicated a minimum shear fixation best suited for use as coatings on implants since they do not
strength of 18.5 MPa, substantially higher than has readily have the required mechanical and processing char-
been obtained with other porous materials with less acteristics which would allow them to be used as bulk
volumetric porosity. structural materials for implants, bone augmentation, or
substitutes for bone graft.
A new porous biomaterial made of tantalum has recently
been developed for potential application in reconstructive
16-18
J. D. Bobyn, PhD, Associate Professor orthopaedics and other surgical disciplines. The materi-
Departments of Surgery and Biomedical Engineering, Montreal General
Hospital, Rm A2-156, 1650 Cedar Avenue, Montréal, Québec, Canada al has an unusually high and interconnecting porosity with
H3G 1A4. a very regular pore shape and size. It can be made into
G. J. Stackpool, MD complex shapes and used either as a bulk implant or as a
S. A. Hacking, MEng surface coating. Our aim in this study was to characterise
J. J. Krygier, CET
Jo Miller Orthopaedic Research Laboratory, Montreal General Hospital this porous tantalum material in terms of the extent and rate
Research Institute, RMLs 1-409, 1650 Cedar Avenue, Montréal, Québec, of bone ingrowth as well as the strength of fixation at the
Canada H3G 1A4.
interface.
M. Tanzer, MD, FRCS C, Clinical Associate Professor
Division of Orthopaedic Surgery, Montreal General Hospital, Rm A2-144,
1650 Cedar Avenue, Montreal, Québec, Canada H3G 1A4.
Materials and Methods
Correspondence should be sent to Dr J. D. Bobyn.
©1999 British Editorial Society of Bone and Joint Surgery Implants. The manufacture of the porous tantalum begins
0301-620X/99/59283 $2.00 with the pyrolysis of a thermosetting polymer foam pre-
VOL. 81-B, NO. 5, SEPTEMBER 1999 907
908 J. D. BOBYN, G. J. STACKPOOL, S. A. HACKING, M. TANZER, J. J. KRYGIER
Fig. 1a Fig. 1b
Fig. 1c
cursor to obtain a low-density vitreous carbon skeleton tion, Allendale, New Jersey) for use in a canine model as a
which has a repeating dodecahedron array of pores inter- transcortical implant (Fig. 1). They had two different pore
connected by smaller openings or portals. Commercially sizes. The mean pore size was determined using two tech-
pure tantalum is deposited into and about the carbon skele- niques in each of which the data were expressed as a mean
ton using chemical vapour deposition/infiltration (CVD/ with 95% confidence intervals (CI). The first involved
CVI) to create a porous metal construct. Because of the measuring the diameter of 100 dodecahedron-shaped pores,
crystallographic growth and orientation of the tantalum excluding the smaller connecting portals, based on second-
during deposition, the process results in a surface with a ary electron SEM images of the two pore sizes. This
distinct microtexture as shown in Figure 1. Thin CVD/CVI method gave a mean pore diameter of 547 µm (95% CI 537
films of 10 to 100 µm can impart very high mechanical to 557) for implants of smaller pore size and 710 µm (95%
properties because the deposit is typically 100% dense, CI 696 to 724) for those of the larger. The second technique
with grain sizes of less than 1 to 5 µm and impurities of used the line intercept method based on the digital meas-
<0.05%. The typical thickness of the tantalum coating is urement of 1000 pore openings on SEM images of ten
19
approximately 50 µm. An increase in thickness of the different implants. It included all pore lengths inter-
tantalum deposition can affect the pore size and mechanical cepting the grid lines, not just the full diameters of the
properties. pores, and therefore gave smaller mean pore sizes with
Cylindrical implants 5 mm in diameter and 10 mm in larger CIs. By this method the mean pore size was found to
length were made from porous tantalum (Implex Corpora- be 430 µm (95% CI 413 to 447) in implants with the small
THE JOURNAL OF BONE AND JOINT SURGERY
CHARACTERISTICS OF BONE INGROWTH AND INTERFACE MECHANICS OF A NEW POROUS TANTALUM BIOMATERIAL 909
Table I. Extent of mean bone ingrowth (%) as a function of pore size and time
Bone ingrowth
Time 95% CI
(weeks) Small pore Large pore for difference p value
2* - 13.3 (n = 24) - -
(95% CI 10.8 to 15.8)
3* - 23.0 (n = 24) - -
(95% CI 20.0 to 26.0)
4 41.5 (n = 12) 52.9 (n = 23)† 6.9 to 15.9 0.00003
(95% CI 37.3 to 45.8) (95% CI 50.4 to 55.4)
16 63.1 (n = 18) 69.2 (n = 24) 1.5 to 10.8 0.01
(95% CI 58.2 to 68.0) (95% CI 67.0 to 71.5)
52 79.7 (n = 24) 70.6 (n = 23)† -12.9 to -5.4 0.000008
(95% CI 76.9 to 82.5) (95% CI 68.3 to 73.0)
* implants of small pore size were not studied at two and three weeks
† 1 implant at four and 52 weeks was not included because of a sectioning error
unpaired Student’s t-tests at the 95% CI to assess sig- extent of bone ingrowth increased to a mean of 52.9% for
nificance. Data for shear strength from the successful the large pore size compared with 41.5% for the small pore
mechanical tests at four weeks were expressed as a mean size, a difference which was statistically significant. At 16
with 95% CI. An unpaired Student’s t-test was used to weeks, the difference in mean ingrowth between the large
compare these with data from an earlier four-week mechan- pore size (69.2%) and the small pore size (63.1%) was also
ical study in which the dimensions of the implant, the significant. By 52 weeks, the mean extent of ingrowth of
animal model, surgical technique, mechanical test protocol, implants with a small pore size (79.7%) was significantly
1
and sample size were virtually identical. greater than that of those with the large size (70.6%).
Backscattered SEM showed a clear pattern of formation
Results of new bone within the porous tantalum material. At two
weeks, the primary source of the initial formation of bone
Histological analysis. All the groups of data from the was the intramedullary canal and the edges of the drill hole
histological analyses were found to have a normal distribu- (Fig. 3). Ingrowth was generally scant and only small
tion and were evaluated by Student’s t-tests. Table I gives regions of close apposition of bone to the struts of the
details of bone ingrowth and the results of statistical analy- porous tantalum were observed. At three weeks it appeared
sis on differences between means. In implants of large pore that more new bone arose from, or was continuous with, the
size, the mean extent of ingrowth at two and three weeks drilled edges of the cortex (Fig. 4). In some sections there
was 13.3% and 23.0%, respectively. At four weeks, the was a slight periosteal reaction and new bone seemed to be
Fig. 3 Fig. 4
Backscattered scanning electron micrograph of a two-week implant with a Backscattered scanning electron micrograph of a three-week implant with
large pore size showing bone growth of 13%. New bone appears to arise a large pore size showing bone ingrowth of 21%. Compared with the
from the intramedullary canal and the edges of the drill hole, with little implant at two weeks (Fig. 3) there is increased continuity of new bone
bone on the periosteal surface. The bony trabeculae are immature and with the drilled cortical edges, additional new bone arising from the
slender. periosteal surface and a general thickening of the bony trabeculae.
Fig. 5 Fig. 6
Figure 5 – Transmitted light photomicrograph of an interface region of a four-week implant with a small pore size. The reversal line from
the original drill hole is evident and the microtexture of the tantalum struts is apparent (paragon15). Figure 6 – Backscattered scanning
electron micrograph of a 16-week implant of small pore size showing ingrowth of 76%. There are many regions of contact between new
bone and the tantalum struts. A pronounced periosteal reaction has resulted in additional incorporation of the implant by new bone.
Haversian remodelling is evident within the porous network.
Fig. 8a Fig. 8b
Transmitted light micrographs of a transverse section through a 52-week implant with small pore size. There are multiple regions of intimate bone-strut
contact and evidence of a vascular supply throughout the ingrown bone (paragon; a)11, b)27).
implants of both pore sizes. This resulted in a mean shear porosity of porous tantalum. The latter, however, has a high
fixation strength of at least 18.5 MPa (2700 PSI). Com- strength:weight ratio and overall mechanical properties
17
pared with previous studies using porous-coated trans- which would be adequate for most clinical applications.
cortical implants, high fixation strength occurred much The bulk properties of the porous tantalum can be con-
earlier with porous tantalum. The data from this investiga- trolled by the manufacturing process; additional strength
tion are best compared with those of an earlier study in can be obtained simply by additional deposition of tantalum
which sintered, beaded cobalt-chrome transcortical on to the struts. This indicates the need for supplementary
implants spanning similar pore sizes were used because characterisation of the mechanical properties of the materi-
1
both had equivalent protocols. The maximum mean shear al with different processing parameters.
strength obtained at four weeks with the beaded cobalt- The pore sizes of both types of implant which we
chrome implants was 9.3 MPa (95% CI 8.3 to 10.3), a evaluated were at the upper limit of the characteristics of
difference of 9.2 MPa (95% CI 7.8 to 10.6) which was pore size of conventional porous materials. Nevertheless,
significant (Student’s t-test; p=0.004). Studies using other the rates of bone ingrowth and the overall extent of filling
porous metals and different implants and testing techniques of the porosities with new bone were very high. There were
have reported fixation strengths to cortical bone at four statistical differences in the mean extent of bone ingrowth
3,21
weeks ranging from 1.2 MPa to 13.1 MPa. between the two pore sizes at the different time periods.
The increased rate of development of the interfacial Implants with the large pore size initially had greater
shear strength with porous tantalum can best be attributed ingrowth, but by 52 weeks those with the small pore size
to the higher volume fraction available for ingrowth. While were more completely ingrown. These differences may
fibre metal coatings have a porosity of 40% to 50% and have resulted from the slight inherent variations in pore
sintered-beaded coatings of the type studied by Bobyn et characteristics between the two types of implant or from
1
al of only 30% to 35%, the porous tantalum material interanimal variability in the healing response. In any case,
examined in this study had a substantially higher porosity the relative differences were not large and unlikely to result
of 75% to 80%. This meant that for any given percentage in any practical or meaningful clinical consequence. The
filling, a greater volume of bone was present within the material of small pore size, by virtue of its higher density of
porous tantalum, thus giving a proportionate increase in struts per unit volume, inherently has stronger mechanical
interface strength. The end result was a faster rate of properties and hence would probably be preferred for most
development of strength. The higher porosity of the porous clinical applications.
tantalum also theoretically allowed a higher ultimate It is possible that the surface microtexture of the struts
strength to develop. Clinically, however, the rate of fixation forming the porous material contributed to the overall
may be more important since the time required for second- osteogenic response. Cell-culture studies and studies in
ary stabilisation of an implant by bone ingrowth can influ- animals with both unloaded and dynamically loaded
ence the load-bearing after operation. implants have shown that microtextured surfaces such as
The measured strength of the interface probably repre- those produced by grit blasting or acid etching are highly
22-25
sents a lower bond since half of the implants at four weeks osteophilic. The histological studies clearly showed
and all at 16 weeks failed in compression before rupture of that the porous tantalum served as an effective scaffold for
the interface. The compressive failure indicated a certain relatively complete incorporation with new bone by 16
reduction in mechanical properties associated with the high weeks, with little change after 52 weeks of implantation.
THE JOURNAL OF BONE AND JOINT SURGERY
CHARACTERISTICS OF BONE INGROWTH AND INTERFACE MECHANICS OF A NEW POROUS TANTALUM BIOMATERIAL 913
Although not as realistic as a fully-functional load- One or more of the authors have received or will receive benefits for
personal or professional use from a commercial party related directly or
bearing model, the transcortical model is very useful for the indirectly to the subject of this article.
initial characterisation of new porous biomaterials. It
allows control of several parameters which influence the References
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