Annals of BiomedicalEngineering, Vol. 20, pp. 583-594, 1992 Printed in the USA. All rights reserved.

0090-6964/92 $5.00 + .00 Copyright 9 1992PergamonPress Ltd.

Orthopedic Prosthesis Fixation

Joon B. Park
Department of Biomedical Engineering The University of Iowa Iowa City, IA (Received 11/23/90) The fixation of orthopedic implants has been one o f the most difficult and challenging problems. The fixation can be achieved via: (a) direct mechanical fixation using screws, pins, wires, etc.; (b) passive or interference mechanical fixation where the implants are allowed to move or merely positioned onto the tissue surfaces; (c) bone cement fixation which is actually a grouting material; (d) biological fixation by allowing tissues to grow into the interstices of pores or textured surfaces o f implants; (e) direct chemical bonding between implant and tissues; or (f) any combination o f the above techniques. This article is concerned with various fixation techniques including the potential use of electrical, pulsed electromagnetic field, chemical stimulation using calcium phosphates for the enhancement o f tissue ingrowth, direct bonding with bone by glass-ceramics and resorbable particle impregnated bone cement to take advantages of both the immediate fixation offered by the bone cement and long term fixation due to tissue ingrowth. Keywords-Orthopedic prosthesis, Fixation, Bone cement, Biological fixation, Tissue ingrowth, Stimulation. INTRODUCTION Ever since the introduction o f bone cement for the fixation of artificial hip joints by Dr. John Charnley, on the advice of Dr. D. Smith in the late 1950s, the procedure has been popularized throughout the world (5,6,7). The initial success of the procedure has been tempered by problems related not only to bone cement, but also the implants per se (6,1 I, 12,24,55). One o f the inherent problems of orthopedic implantation is the fixation and the maintenance of a stable interface between the device and the host tissue. The fixation can be classified into several categories as given below (also see Fig. I): 1. mechanical fixation, either actively by using screws, bolts, nuts, wires, etc., or passively by interference (press) fit; 2. use of grouting materials such as acrylic bone cement;

Acknowledgment--This article was originally typed by Mrs. Diane Graber and was presented at the 1989 meeting of the Korean Orthopedic Association, Pusan, Korea, April 1989. Address correspondence to Joon B. Park, Department of Biomedical Engineering, The University of Iowa, Iowa City, IA 52242. 583

584

J.B. Park

,SCREWS

9BONE CEMENT

'POROUS LAYER

GLASS-CERAMIC LAYER

(a)

(b)

(c)

(d)

(e)

FIGURE 1. Schematic illustration of the various fixation methods: (a) Direct interference or (passive) noninterference fit; (b) mechanical fixation using screws, bolts, nuts, wires, etc.; (c) bone cement or grouting; (d) porous ingrowth (biological) fixation; and (e) direct chemical bonding using adhesives or after coating with direct bonding material layer.

3. biological (porous ingrowth) fixation; and 4. direct (chemical) bonding using adhesives or after coating with direct bonding layer. Enhancement of the techniques can be made by (a) a combination of (2) and (3), by incorporating resorbable particles into bone cement; or (b) a combination of (3) and (4). Also, porous ingrowth can be combined with electrical or electromagnetic stimulation. The most frequent fixation problem is the long-term loosening of the implant. Many factors, such as mismatch of the physical properties between tissues and implant, infection, biocompatibility of the implant, surgical techniques, wear and wear particulates, to name but a few, could be the causes of late loosening (14,15). We will review some of these fixation techniques and discuss some possible solutions as they relate to the total (hip and knee) joint arthroplasty.

?
BONE CEMENT + RESORBAB LE PARTICLE

MAGNETIC COILS

"POROUS LAYER (g)

(f)

FIGURE 1. (Contd.) (f) Bone cement with resorbable particles; and (g) porous ingrowth controlled by using electrical or electromagnetic stimulation.

Orthopedic Prosthesis Fixation

585

MECHANICAL FIXATION Early designs of total hip prosthesis used bolts and nuts to fix the femoral component to the femur (26,54). This technique was abandoned due to the massive tissue reaction by the wear particles released by the metal on metal friction between the cup and femoral head and unstable fixation of the femoral components for long time. It is also possible that the stress concentration around the holes would lead to the failure of the fixation. The passive mechanical fixation has been applied, in limited circumstances, to hip and finger joint prostheses. Due to the nature of the loading (mostly compressive) and shape (wedge), an interference or press fit can be used to fix the femoral stem of a hip joint. This technique is used largely for ceramic stems, since the large size of the stem (it must be large due to failure unpredictability of brittle materials such as alumina ceramic) can distribute the stresses over a large area, thus diminishing stress necrosis of bone (27). This fixation often results in induced collagenous membrane formation at the interface between bone and implant, unless there is negligible relative motion between them (23). It is also conceivable that under load the sinking of the implant may continue throughout the life of the implant. The passive fixation of the finger joint is based on an entirely different concept of fixation (50). It depends on the development of a collagenous membrane between implant and bone in which the prosthesis glides in and out. This fixation can provide minimal rigidity to the joint, i.e., it may be good enough for holding a cup of coffee, but not for putting screws into a wooden block.
BONE CEMENT FIXATION

Bone cement fixation creates two interfaces: cement/bone (C-B) and cement/implant (C-I). According to an earlier report (1), the incidence of loosening for the femoral prostheses was evenly divided at about 10~ and 11o70 for (C-I) and (C-B) interfaces, respectively. The cement/implant interface loosening can be minimized by precoating with bone cement or polymethylmethacrylate polymer. Precoating can achieve a good bonding between the "cement" and prosthesis during the manufacturing process. During surgery, the freshly doughed cement adheres well to the precoated cement (2,36,37,40,41,44). The problems at the bone/cement interface cannot be easily overcome since these problems arise from the intrinsic properties of the bone cement as well as extrinsic factors such as cementing technique. The toxicity of the monomer, inherent weakness of the cement as a material (see Table 1), and inevitable inclusion of the pores can contribute to the problem of loosening at the bone/cement interface (32). The bone/cement interface strength may be enhanced further by the bone grown into the cement. Bone cement can be used for immediate fixation, yet provide tissue ingrowth space later by incorporating resorbable particles (such as bone) as shown in Fig. 2. Recent studies (9,25,38) indicate that the concept can be used effectively at least for the rabbit and canine models. In one experiment (9), the bone-particle impregnated bone cement was used to fix femoral stem prostheses in femora of dogs (one side was experimental, the other was control) and after a predetermined time period, the femora were harvested and sectioned into disks for the push-out test to measure the interfacial strength between the bone and cement interface. The results (Fig. 3) show that the experimental side increased its strength up to 5 months while

586

J.B. Park
TABLE 1. Mechanical properties of materials used for joint prosthesis and bone. Young's Modulus (GPa) UTS a (MPa) Elongation (%) Density (g/cm 3)

Materials Metals 316L S.S. (wrought) Co-Cr-Mo (cast) Co Nic Cr Mo (wrought) Ti6AI4V Ceramics Alumina (AI203, polycrystalline) Glass-ceramic (Bioglass| Hydroxyapatite Polymers PMMA c (solid) PMMA bone cement UHMW d Polyethylene Bone Femur (compact), long axis Femur (compact), tangential Spongy bone

200 230 230 110 400 200 120 3 2 1 17 12 0.1

1000 660 1800 900 260 200 200 65 30 30 130 60 2

9 8 8 10 nil nil nil 5 3 200 3 1 2.5

7.9 8.3 9.2 4.5 3.9 2.5 b 3.2 1.18 1.1 0.94 2.0 2.0 1.0

aUTS: ultimate tensile strength. bEstimated values. CpMMA: poly(methylmethacrylate). dUHMW: ultra high molecular weight (>2 106 g/mole). (Adapted from data, with permission, from [34]).

-'
STRENGTH OF SYSTEM

Start boneparticle resorption jCement/Bone "x~nterfoceS t ~ ---After BoneIngrowth

t %

/ /

/I

/
/ I

TIME
FIGURE 2. Basic concept of the bone cement with resorbable particle fixation. Immediate fixation is achieved as in the ordinary bone cement with the enhanced biological fixation to be achieved later for a prolonged stabilization of the implant.

Orthopedic Prosthesis Fixation

587

I %Experimental

I ,[

6 INTERFACIAL SHEAR STRENGTH 4 (MPa) /Control 2

Conine femur
0 I i I t i t

I0

12

IMPLANTATION PERIOD (months) FIGURE 3. Maximum interfacial shear strength between bone and bone cement versus implant period when the femoral stems were implanted with ordinary bone cement and cement with boneparticles. In both cases the interfacial strength was stabilized after 5 months for this canine model (reprinted with permission from [9]).

the control side decreased slightly. The histology also showed the integration of tissues into the spaces of the dissolved particles. Of course, care should be taken to control the amount of particles in order to balance out the increased viscosity. Failure to do so may cause cementing problems and decreased mechanical strength of the cement. Fatigue properties improved with higher particle inclusion, however, it was found that about 30~ (by weight) of bone particles can provide sufficient interconnected porosity for bony ingrowth and yet give reasonable compromises to other parameters (25). The bone-particle impregnated bone cement has been used clinically, but its long-term success remains to be proven (10). POROUS INGROWTH (BIOLOGICAL) FIXATION Efforts to develop a viable interface between the tissue and implants have been made ever since Moore (28) designed a femoral prosthesis, which had a fenestrated large hole in the proximal region as shown in Fig. 4. Smith (47) tried to develop a bone substitute with porous aluminate ceramic impregnated with an epoxy resin called Cerocium | Although the material demonstrated a good adherence to the tissues, the pore size (average 18 ~m diameter) was too small to allow any bony tissue ingrowth. Later, ceramics (24,43), metals (18,30), and polYmers (46) were used to test the ingrowth idea. Basically, any biocompatible material will allow bony tissues to grow into any spaces large enough to accommodate osteons. However, to be continuously viable the space must be large enough (more than 75 ~m diameter for the bony tissues) and contiguous to the surface of bone matrix (16). In addition, Wolff's law dictates that the ingrown tissues should be subjected to bodily loading in order to prevent

588

J.B. Park

FIGURE 4. Schematic illustration of the Moore femoral hip prosthesis. Note the large fenestrating holes in the proximal region for tissue ingrowth fixation (reprinted with permission from

[28]).

resorption, even after the initial ingrowth had taken place. The same principle also makes it difficult to have a uniform tissue ingrowth throughout the implant surface. This is the reason why the tissue ingrowth takes place where the stress transfer occurs, e.g., in the distal lateral region of the femoral stem of the artificial hip joint. Figure 5 shows the general trends of the fixation (interfacial) strength variation with implantation period in animals up to 6 months for metallic implants (Co-Cr alloys, Ti and its alloys, and stainless steel). (The graph is plotted from the data collected by M. Spector [49].) A few remarks can be made from this data. Firstly, the

20

Porous Metals

0
MAXIMUM

" "'"
/0

.-

.........

~ U''''0
""

Cat,dog,goat, rabbit, rhesus monkey

INTERFACIAL S ERT E GH P) IO HA sRN T Mo (

"-.

! ~

"
s

"
"~

"'"'O

/ ~ 1 7 6 ,'"

~
~ "'-..
"..

Average

:g- o,, 1, ' h / I o J ,/o ,,0

0 ,"Y'-"~

"8
0

"o...
-...

o .

8 12 16 IMPLANTATION PERIOD (weeks)

20

24

~,

FIGURE 5. Maximum interfacial shear strength between bone and porous metal implants versus implant of various metals and animals (adapted with permission from [49]).

Orthopedic Prosthesis Fixation

589

maximum interfacial shear strength between bone and porous implant peaked at about 12-13 MPa in about 6-8 weeks regardless of the implant material, animal type, or location of the implants (i.e., cortical or cancellous bone and transcortical or intramedullary canal). Secondly, the data are widely scattered. (The original data showed wide variations, therefore, they are not distinguished among the variables.) The decrease in interfacial strength with time after peak for the metallic implants is somewhat distressing since this may also be true with human patients. This may be caused by two factors. The first is that of bone resorption from the initially ingrown area due to the stress shielding. The second is the release of a large number of metal ions due to the much increased surface area of the porous implant. Porous polymers did not have the decreasing trends as shown in Fig. 6 (48). This may be interpreted as the lack of stress shielding (after bone is ingrown into the pores) due to the low modulus of the polymers. However, there are not enough data available to come to a definitive conclusion (22,45,48,52). Further problems with biological fixation are: (a) the unforgiving nature of the surgery, (b) the long immobilization time for tissue ingrowth, (c) the uncertainty of the time to ambulation, (d) the difficulty in eradicating infection, and (e) once the interface is destroyed by accidental overloading, it cannot be regrown with certainty. Moreover, the porous coating may weaken the underlying prosthesis itself and, in case of metals, there is an increased danger of corrosion fatigue due to the increased surface area (4,29). Due to these problems and clinical results of porous fixation, some

20-

Porous Polymers
Dogs

MAXIMUM INTERFACIAL SHEAR STRENGTH (MPo)

r / 9 /

IO.

Averoge

....

......

~176
!

0 0 4 8 12 16
IMPLANTATION P E R I O D (weeks)

20

FIGURE 6. Maximum interfacial shear strength between bone and porous polymeric implants versus implant (adapted with permission from [48]).

590

J.B. Park

investigators have insisted that the bone cement fixation technique is still the gold standard at this time (20). In order to alleviate these problems several modifications have been tried: . Precoating the metallic porous surface with ceramics or carbons. This method has been tried with limited success (8,51). The problem of coating deep in the pores, and the thermal expansion difference between the metal and ceramic materials, make uniformity and quality of adherent coating very difficult. An attractive material for coating is hydroxyapatite ceramic, which is similar to bone mineral. It is not yet conclusive that this material is more beneficial than other ceramics. Some preliminary studies in our laboratory indicate that during the early period o f fixation, the bioactive hydroxyapatite coating may be more beneficial, but the effect may diminish after 3 weeks as shown in Fig. 7. The graph is for simple cortical bone plug experiment performed on canine femora (35). Others have shown promising results with the same material system used on rabbits, instead o f canines, as in our study (31). Some cautioned the use of bioactive materials as coatings for lack of pertinent data to evaluate adequately at the present time (22). . Precoatinz with porous polymeric materials on metal stem. Theoretically, this method has two distinctive advantages over ceramics or the carbon coating method discussed above (19,22,45,48,52). Firstly, the lowmodulus polymeric material could transfer the load from the implant to the bone more gradually and evenly and thus, prevent stress-shielding effects on the ingrown tissues. Secondly, this method would prevent the metallic surface ion

30

Canine femur

20 INTERFACIAL SHEAR STRENGTH (MPo)

10

.......

/_HA_coated

X,'" ~
0 0
|]P~I I I I I

I !

Porous Ti alloy
I

I0

12

14

I M P L A NT PERIOD (weeks) FIGURE 7. Maximum interfacial shear strength between bone and bioactive ceramic coated porous plug implants versus implant period when the plugs with and without (control) coating were implanted in the cortices of canine femora.

Orthopedic Prosthesis Fixation

591

release, i.e., less corrosion of the metal. One major problem with this technique is the weak interfacial strength between the polymer and metallic stem especially in dynamic loading conditions in vivo. 3. Enhancement of porous ingrowth with electrical or electromagnetic stimulation. This technique combines the porous ingrowth with the stimulating effects of electrical and/or electromagnetic stimulation (33,39,53). Direct current stimulation can indeed accelerate tissue ingrowth in the early stages of healing as shown in Fig. 8, but its effect diminishes over time (53). Direct current stimulation has one distinctive problem: the invasive nature of the power source. The pulsed electromagnetic field stimulation is a better method since the stimulation can be carried out extracorporeally. A preliminary study using canine femur indicates that it can be effective as shown in Fig. 9 (33). More studies are needed to lend further support.

o
600
0.8 FRACTURE STRENGTH 0.6

Stimulated~/

9
400

0.4

ntrol
0 zx
I I

200

0.2

A
I

Rabb Femur

20

40

60

IMPLANT PERIOD (days)

FIGURE 8. Maximum interfacial shear strength between bone and porous ceramic plug implants versus implant period with and without (control) direct current stimulation. Plugs were implanted in the cortices of rabbit femora (reprinted with permission from [39]).

592

3.0]
(M Pa)

J.B. Park

INTERFACIAL SHEAR STRENGTH

I
o

Control

.....
,

b_ I0

,-, ^ ~

,~ ~ " 15

"r~\

'., 20 distal

SECTION NUMBERS

FIGURE 9. Maximum interfacial shear strength between bone and porous metallic intramedullary implant with and without (control) pulsed electromagnetic field stimulation. The porous implants were implanted in the medullary canals of canine femora (one side was control, the other was experimental) (33).

4. Porous ingrowth with the use of filling materials. There has been some effort to use filling materials around the porous implant, since it is very difficult to prepare the tissue bed with the exact shape of the prosthesis in order to eliminate the micromovement o f the prosthesis after implantation. Bone matrix proteins and hydroxyapatite crystals can be used for this purpose (42). The success of this technique has not been fully documented. D I R E C T BONDING B E T W E E N BONE A N D I M P L A N T Some glass-ceramics tend to achieve direct bonding with the bone through a selective dissolution of the surface film (3,17,21). Some researchers have reported a direct bonding of tissues to hydroxyapatites (13). It has been difficult to coat a metallic surface with these materials, due to the large difference in the thermal expansion coefficient between the coating and base materials. The glass-ceramics have not been used to make load bearing implants, due to their brittleness.
C O N C L U D I N G REMARKS

Orthopedic surgeons often suggest that the fixation of implants should not be too strong since it would be very difficult to remove, should it become necessary to do a revision arthroplasty to restore its function. The two requirements could be mutually exclusive since the interface must be strong enough to hold the prosthesis in vivo, but not so strong that it impairs any remedial measures. Another problem is related to the more frequent use of the implants for the younger patients, which requires firmer fixation and longer implant life. The original expectation of cementless porous ingrowth fixation for the young is tempered somewhat and we need to explore a longer lasting method of fixation.

Orthopedic Prosthesis Fixation

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REFERENCES

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31. Oonishi, H.; Yamamoto, M.; Ishimaru, H.; Tsuji, E.; Kushitani, S.; Aono, M.; Ukon, Y. Comparisons of bone ingrowth into porous Ti-6AI-4V beads uncoated and coated with hydroxyapatite. In: Bioceramics. Oonishi, H.; Aoki, H.; Sawai, K., eds. Tokyo and St. Louis: Ishiyaku EuroAmerica, Inc., 1989: pp. 400-405. 32. Park, J.B. Acrylic bone cement: In vitro and in vivo property-structure relationship-A selective review. Annals Biomed. Eng. 11:297-312; 1983. 33. Park, J.B. Implant fixation by pulsed electromagnetic field stimulation. Unpublished study; 1983. 34. Park, J.B. Biomaterials science and engineering. New York: Plenum Pub.; 1984: pp. 282-288. 35. Park, J.B. In vivo evaluation of resorbable surface bone implant. Unpublished study; 1988. 36. Park, J.B.; Barb, W.; Kenner, G.H.; von Recum, A.F. Intrameduilary fixation of artificial hip joints with bone cement precoated implants. II. Density and histological study. J. Biomed. Mater. Res. 16:459-469; 1982. 37. Park, J.B.; Barb, W.; Davies, J.P. Long-term evaluation of precoated canine femoral prosthesis. In: Saha, S., ed. Biomedical Engineering I: Recent developments. New York: Pergamon Press; 1982: pp. 295-298. 38. Park, J.B.; Choi, W.W.; Liu, Y.K.; Haugen, T.W. Bone particle impregnated polymethylmethacrylate: In vitro and in vivo study. In: Van Steenberghe, D., ed. Tissue integration in oral and facial reconstruction. Amsterdam: Excerptu Medica; 1986: pp. 118-124. 39. Park, J.B.; Kenner, G.H. Effect of electrical stimulation on the tensile strength of the porous implant and bone interface. Biomater. Med. Dev. Artif. Org. 3:233-243; 1975. 40. Park, J.B.; Malstrom, C.S.; von Recum, A.F. Intramedullary fixation of implants pre-coated with bone cement: A preliminary study. Biomater. Med. Dev. ArtiL Org. 6:361-373; 1978. 41. Park, J.B.; von Recum, A.F.; Gratzick, G.E. Pre-coated orthopedic implants with bone cement. Biomater. Med. Dev. Artif. Org. 7:41-53; 1979. 42. Parsons, J.R.; Ricci, J.L.; Liebrecht, P.; Salsbury, R.L.; Patras, A.S.; Alexander, H. Enhanced stabilization of orthopaedic implants with spherical hydroxylapatite particulate. Dublin, CA: OrthoMatrix, Inc.; 1987. 43. Predecki, P.; Stephan, J.E.; Auslander, B.E.; Mooney, V.L.; Kirkland, K. Kinetics of bone growth into cylindrical channels in aluminum oxide and titanium. J. Biomed. Mater. Res. 6:375-400; 1972. 44. Raab, S.; Ahmed, A.M.; Provan, J.W. Thin film PMMA precoating for improved implant bonecement fixation. J. Biomed. Mater. Res. 16:679-704; 1982. 45. Sadr, B.; Arden, G.P. A comparison of the stability of proplast-coated and cemented Thompson prosthesis in the treatment of subcapital femoral fractures. Injury 8:234-237; 1987. 46. Sauer, B.W.; Weinstein, A.M.; Klawitter, J.J.; Hulbert, S.F.; Leonard, R.B.; Bagwell, J.G. The role of porous polymeric materials in prosthesis attachment. J. Biomed. Mater. Res. Symposium 5:145156; 1974. 47. Smith, L. Ceramic-plastic material as a bone substitute. Arch. Surg. 87:653-661; 1963. 48. Spector, M. Bone ingrowth into porous polymers. In: Williams, D.F., ed. Biocompatibility of orthopedic implants, Vol II. Boca Raton, FL: CRC Press; 1982; pp. 89-128. 49. Spector, M. Bone ingrowth into porous metals. In: Williams, D.F., ed. Biocompatibility of orthopedic implants, Vol II. Boca Raton, FL: CRC Press; 1982: pp. 55-88. 50. Swanson, A.B. Flexible implant resection arthroplasty in the hand and extremities. St. Louis: C.V. Mosby Co.; 1973. 51. Thomas, K.A.; Cook, S.D.; Renz, E.A.; Anderson, R.C.; Haddad, Jr., R.J.; Haubold, A.D.; Yapp, R. The effect of surface treatments on the interface mechanics of LTI pyrolytic carbon implants. J. Biomed. Mater. Res. 19:145-160; 1985. 52. Tullos, H.S.; McCaskill, B.L.; Dickey, R.; Davidson, J. Total hip arthroplasty with a low-modulus porous-coated femoral component. J Bone Joint Surg. 66A:888-898; 1984. 53. Weinstein, A.M.; Klawitter, J.J.; Cleveland, T.W.; Amoss, D.C. Electrical stimulation of bone growth into porous A1203. J. Biomed. Mater. Res. 10:231-247; 1976. 54. Williams, D.F.; Roaf, R. Implants in surgery. London: W.B. Saunders; 1973. 55. Wroblewski, B.M. 15-21 year results of the Charnley low-friction arthroplasty. Clin. Orthop. Rel. Res. 211:30-35; 1986.