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4.

Mixing:
The Benefit of Vacuum Mixing
Jian-Sheng Wang

Summary techniques have the net effect of improving the overall


quality of the cement.
Vacuum mixing of bone cement has been used in ce- Numerous studies have shown that, compared to oth-
mented hip-joint replacement procedures for over two de- er mixing methods, vacuum mixing reduces monomer
cades. Although literature on bone cement is voluminous, evaporation and exposure in the operating room. Fur-
relatively few studies have reported the effects of vacu- thermore, it prevents air entrapment in cement, reduces
um-mixing methods on the cemented hip replacement. cement porosity, decreases the number of unbounded
While it has been proven that vacuum mixing improves particles in cement and increases the cements mechanical
the mechanical properties of bone cement, other effects strength. Clinical observations have revealed that vacuum
need to be clarified. This chapter discusses the effects of mixing of bone cement improves mid- and long-term
vacuum mixing on cement quality, cement homogeneity, survival rates of total hip implants [41].
the cement-prosthesis interface and the operating room This chapter focuses on the effect of vacuum mixing
environment. It also discussed vacuum mixing in terms of on the characteristics and the quality of bone cement used
bone-cement shrinkage and antibiotic release in total hip in arthroplasty.
replacements.

The Evolution of Cement Mixing Systems


Introduction
When bone cement was first used in arthroplasty, it was
Until the 1980s, the composition and preparation of bone hand-mixed in a bowl in the operating room and then in-
cement had not changed from the standards introduced serted by hand or transferred and injected into the desired
by Charnley back in 1959. Then, in the 1980s, techniques location. Because PMMA comes as a powder composed
for improving cement strength began to be investigated. of prepolymerised particles to be mixed with the liquid
Closed mixing under vacuum was developed initially for monomer, monomer fumes release into the air. Further-
environment reasons, but its benefits in terms of pro- more with hand mixing, a certain amount of porosity
ducing homogenous cement, enhancing the mechanical in the final material, even in lower viscosity cements, is
properties of cement, improving cementing technique unavoidable owing to air entrapment.
as well as safeguarding the operating room environment During the 1980s different vibrating mixing tech-
soon became evident. niques were introduced in the hope of improving mixing
In order to improve the mechanical properties of and thereby bone cement properties [37]. The results,
bone cement and thereby reduce the risk of cement however, were not convincing. While Burke et al. [9]
failure in arthroplasties, substantial efforts have been reported an increase in the cements fatigue life and
invested into the development of new techniques for ultimate tensile strength when centrifugation was used,
bone cement mixing and delivery applications with the a phenomenon they attributed to a reduction in the
objective of reducing macro- and microporosity. These number and size of pores, Rimnace et al. [49] found no
108 Part II Basic Science

improvement in the static or dynamic properties of sever- container to delivery system [11, 43, 62, 69]. Conventional
al brands of bone cement when mixed by centrifugation. mixing of bone cement produces porosity of 516%.
The results seemed to vary significantly depending on the Vacuum mixing produces porosity of 0.11% [38, 65].
type of centrifugation and cement used, and the cement
was not consistently homogenous. Moreover, antibiotics
and radiographic contrast media tended to gather in the Relationship Between Porosity and Fatigue
periphery of the mix, and the upper volume of the cement Property of Cement
often became more porous than the rest of the cement.
At about the same time as vibration and centrifuga- Porosity has been found to be the major cause of de-
4 tion were being developed and tested, closed mixing creased mechanical strength and fatigue life of bone
under vacuum was introduced [4, 35, 36]. After some cement. To ensure its in vivo survival, the cement must
refining, it produced better results than centrifugation, be able to withstand the varying loads it endures. Thus
which was soon thereafter abandoned in favour of vac- fatigue property, which is directly affected by porosity, is
uum mixing, particularly because of the ease of delivery as important in determining the long-term survival of a
when using cartridge mixing. Today, vacuum mixing is joint replacement as static strength.
widely accepted as the method of choice for achieving Fatigue failure occurs when cement cracks are initi-
homogenous cement, reducing porosity and increasing ated as a result of defects in the cement mantle. It is the
cement strength, which is why it is an integral part of presence of large voids within the cement that leads to
Modern Cementing Technique [40]. a rapid propagation of fracture ( Fig. 4.1a). Secondary
cracks develop along the small pores ( Fig. 4.1b). Such

Improvement of Environment

MMA is a toxic, highly volatile organic solvent. Cytotoxic


effects on human fibroblasts in culture media have been
described and attributed to MMA [57]. It is now known
that the adverse effects of working with MMA include
local mucosal irritation i.e., irritation of the respiratory
system, eyes and skin contact sensitivity that may lead
to toxic dermatitis [20, 31, 33, 47]. Indications are head-
ache, nausea and lack of appetite. MMA is not thought to
be carcinogenic to humans under normal conditions of
use. However, techniques should be employed to reduce
medical staff exposure to MMA during cemented implan-
tation. Operating staff should avoid direct contact with
MMA, and room ventilation should be optimised.
Monomer exposure is regulated by law in many coun- a
tries. The exposure limits range from 50100 ppm in dif-
ferent countries in Europe. The exposure of conventional
mixing in open bowl is about 10 ppm in the breathing
zone [8]. Vacuum mixing systems reduce the exposure
by 5070% [53] and eliminate contact with bone cement
during delivery [6, 8, 12, 19, 53]. The working environ-
ment for the operating staff is improved, and the risk of
fume-induced headaches, respiratory irritation and aller-
gic reactions becomes minimal.

Improvements in Cement Quality

Porosity
b

Pores and voids of different sizes in cement are caused by Fig. 4.1a,b. SEM micrograph of fatigue fracture surface. a A large
air from the polymer powder. The air becomes trapped in pore causes stress concentration and initiates crack [27]. b Secondary
the cement during mixing and transferring from mixing crack associated with pores [56]
Chapter 4.1 Mixing: The Benefit of Vacuum Mixing
109 4

fractures are commonly observed in vitro and in vivo [10, Cement-Prosthesis Interface
27, 30, 45, 56]. Because of stress concentration, the initial
crack is likely to start in an area of weakness or at a void Studies have indicated that mechanical loosening of ce-
in the material [29]. Evidence of this cracking has been mented implants originates at the stem-cement interface
found when examining retrieved cement [30, 56]. [28, 30, 60]. Loosening of the cemented stem further
The reduction of porosity prevents or at the very least increases stress in the cement mantle [24, 59]. Extensive
retards the initiation of fatigue propagation. It is known porosity at the cement-stem interface has been found
that vacuum mixing of cement increases mechanical in retrieved cement mantles and in laboratory-prepared
properties [4, 5, 13, 35, 36, 38, 69] largely as a result of specimens [7, 28] ( Fig. 4.3).
decreasing micro- and macropores [62, 66]. Numerous This interface porosity is caused by entrapment of air
studies have confirmed that vacuum mixing enhances at the stem surface during stem insertion and by residual
the fatigue life of the bone cement [17, 23, 34, 43, 45, 52, porosity in the cement. A further cause is the cements
65, 67, 70]. shrinkage away from the colder stem surface which pro-
duces pores [7]. Although cement curing is chemically
initiated, polymerisation is thermally activated. Thus
Cement Homogeneity cement curing starts at the warmer bone surface and pro-
gresses towards the cooler stem. Resultant pores as well as
Bulk form PMMA cement exhibits good biocompatibility residual pores in the cement are driven towards the last
when implanted in bone. However, in particulate form, polymerising region on the stem.
PMMA can evoke a foreign body and chronic inflamma- When cement is mixed under vacuum, cement poros-
tory reaction similar to that seen around loose cemented ity is significantly reduced, producing less porosity at the
arthroplasties [1, 22, 32, 55, 68]. cement-prosthesis interface [7, 61] ( Fig. 4.4). Various stud-
Incomplete mixing of the monomer and polymer may
lead to partially united and, in some cases, free unbonded
cement particles. Vacuum mixing of bone cement not
only decreases the number of voids but also improves the
microscopic homogeneity of Palacos R cement [64]. Elec-
tronic microscopy shows that voids located on the surface
of cement as well as on the fracture surface of cement
invariably contain partially polymerised PMMA particles
and contrast media particles, such as zirconium dioxided
particles ( Fig. 4.2). When cement fracture occurs, less
homogeneous cement may release a larger number of
PMMA spheres and contrast media particles to the bone-
cement interface. These particles may evoke a foreign
body response or stimulate osteoclast activity [50 ,51, 68], Fig. 4.3. In SEM numerous small voids are present on the cement
leading to osteolysis of the surrounding bone. surface at the prosthesis interface [30]

Fig. 4.2. Void on a fracture surface (left) and void located on the surface (right) of a Palacos R cement rod prepared at atmospheric pressure.
Many partially unpolymerised PMMA particles and zirconium dioxide particles are seen in the voids [64]
110 Part II Basic Science

Fig. 4.4. Samples from a cemented implant. The cement was mixed at atmospheric pressure (left), and under vacuum (right). M metal; BC bone
cement

ies have shown that interface porosity affects the debonding release ( chapter 3.1). Surgeons understandably are con-
energy of the interface [43], weakens the resistance of the cerned about the extent to which the mixing procedure
cement to torsional load [15] and decreases fatigue life affects the release of antibiotics from the cement. Studies
of the cement-metal interface [26]. Interface porosity has have shown that the concentrations of several antimicro-
also been linked to the initiation of cement cracks [28, 30, bial agents from antibiotic-loaded bone cement exceed
58]. The evidence is convincing that reduction of interface those obtained by systemic administration [21] as well as
porosity improves the strength of the interface, thereby the minimal inhibitory concentrations of several pathogens
increasing the longevity of cemented implants. according to the National Committee for Clinical Labora-
tory Standards breakpoints lasting from 338 days [3]. Vac-
uum mixing of gentamicin-loaded bone cements has been
Shrinkage shown to effectively reduce the number and size of cement
pores with only a minor reduction in antibiotic release [46].
Cement has 35% volumetric shrinkage after curing [11]. The Norwegian Arthroplasty Register [18] documents the
Concerns over this shrinkage have focused primarily on best results occurring when antibiotic prophylaxis is ad-
the stability of the implant. With vacuum mixing, the volu- ministered both systemically and with bone cement con-
metric shrinkage may be increased from 35% to 57% in taining antibiotics prepared under vacuum.
different cements [44]. In a cemented hip stem, for exam-
ple, the cement grout is along the stem with a long cement
mantle (150200 mm) and thin cement layer (24 mm). Clinical Significance
The shrinkage occurs more along the longitudinal axis
rather than diametrically [14], and it is the diametrical The aetiology of aseptic loosening of total joint arthroplas-
shrinkage that may influence the cement interface. Studies ties appears to be multifactorial, with surgical technique,
have been unable to find differences in diametrical shrink- cementing technique, cement quality, cement viscosity,
age or gap formation between cement and prosthesis when prosthesis design, wear debris, joint fluid pressure and
a reduced porosity cement is used [14, 63]. Shrinkage, micromotion all being involved. Although improved sur-
however, within the cancellous bone bed can be regarded gical techniques have increased the probability of prosthe-
as beneficial ( chapter 3.6), as some interface gaps allow sis survival, reducing or eliminating bone cement fracture
for re-vascularisation [16]. Vacuum mixing of cement has by improving its material strength will further enhance
not been found to negatively affect interface strength be- the longevity of cemented prostheses.
tween cement and prosthesis. RSA ( chapter 7.3) showed The affects of porosity reduction on the longevity
a stable cemented implant in early and middle term studies of the cement mantle and on the survival rate of a joint
of vacuum-mixed cemented implants [2, 48]. replacement are still debated. In favour of porosity reduc-
tion is the fact that no direct clinical evidence has ever
shown an association between reduced survival rates and
Antibiotic Release porosity reduction [39]. Janssen et al. [29] explain the
apparent contradiction of porosity by means of a finite
While vacuum mixing reduces the porosity of bone cement, element model showing that when stresses are distributed
it is thought that the process may adversely affect antibiotic homogenously in cement, pores act as crack initiators;
Chapter 4.1 Mixing: The Benefit of Vacuum Mixing
111 4

whereas under inhomogeneous stress conditions, crack antibiotic-impregnated polymethylmethacrylate bone cement. J
Biomed Mater Res 24:57380
formation is governed by local stress intensities. The study
6. Bettencourt A, Calado A, Amaral J, Vale FM, Rico JM, Monteiro
suggests that mechanical failure of cemented femoral J, Castro M (2001) The influence of vacuum mixing on methyl-
components is initiated in areas where stress concen- methacrylate liberation from acrylic cement powder. Int J Pharm
trations are generated. Therefore, the effect of reduced 219:8993
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limited and clinically detectable only in large studies.
78(3):34956
It remains clear, however, that with pores located in 8. Buchhorn GH, Streicher RM, Willert HG (1992) Exposure of surgical/
areas of high stress concentrations, the cement mantle orthopedic operating room personnel to monomer vapors during
will fail rapidly. The Swedish Hip Register gives a risk the use of bone cements--review of the literature and report of
experiences. Biomed Tech (Berl) 37:293302
ratio of vacuum mixing to revision of 0.74 after five years
9. Burke D, Gates E, Harris W (1984) Centrifugation as a method of
from implantation [41], suggesting that vacuum mixing improving tensile and fatigue properties of acrylic bone cement. J
improves the mid- to long-term survival rate of THA sig- Bone Joint Surg (Am) 66:126573
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Take Home Messages
I I 14. Davies JP, Harris WH (1995) Comparison of diametral shrinkage
of centrifuged and uncentrifuged Simplex P bone cement. J Appl
Vacuum mixing significantly reduces macro- and Biomater 6(3):20911
15. Davies JP, Kawate K, Harris WH (1995) Effect of interfacial porosity on
micropores in bone cement, thereby enhancing
the torsional strength of the cement-metal interface. 41st Annual
the cements mechanical strength. Meetting Orthopedic Research Society, Orlando, FL, USA, p 713
Vacuum mixing also improves cement homogeneity 16. Draenert K, Draenert Y, Garde U, Ulrich C (1999) Manual of cement-
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not been shown to adversely affect prosthesis LI (2003) Antibiotic prophylaxis in total hip arthroplasty: effects
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revision rate of 22,170 primary hip replacements followed 014
a significant effect on effective antibiotic release.
years in the Norwegian Arthroplasty Register. Acta Orthop Scand
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