Total Knee Arthroplasty: Aspects On Improved Fixation in The Younger Patient

Umeå University Medical Dissertations
New Series no 1172 – ISSN 0346-6612
______________________________________
Total knee arthroplasty

Aspects on improved fixation in the younger patient
Av
Anders Henricson
Orthopaedics,
Department of Surgical and Perioperative Sciences
Umeå University
Umeå 2008
Published articles have been reprinted with permission of Clinical Orthopaedics and
Related Research/Lippincott Williams & Wilkins.
Copyright: Anders Henricson and the Department of Surgical and Perioperative Sciences
ISSN 0346-6612
ISBN 978-91-7264-549-3
Printed by Print & Media, Umeå University, Umeå 2008

CONTENTS
PAPERS ........................................................................................................................... 1
ABBREVIATIONS .......................................................................................................... 2
INTRODUCTION ............................................................................................................ 3
History and development of total knee arthroplasty..................................................... 3
Factors related to prosthetic fixation ............................................................................ 6
Patient related factors ............................................................................................... 6
Prosthesis factors .................................................................................................... 10
Mobile bearing TKA .................................................................................................. 17
Trabecular metal ......................................................................................................... 19
Radiostereometric analysis (RSA).............................................................................. 23
Surgical technique ...................................................................................................... 24
AIMS OF THE STUDY ................................................................................................. 26
MATERIAL ................................................................................................................... 27
Patients ....................................................................................................................... 27
Patients with incomplete follow-up............................................................................ 27
Implants ...................................................................................................................... 29
METHODS..................................................................................................................... 34
Clinical evaluation...................................................................................................... 34
Conventional radiography .......................................................................................... 34
Randomization............................................................................................................ 35
RSA (Radiostereometric analysis).............................................................................. 36
Histology .................................................................................................................... 39
Statistics...................................................................................................................... 40
RESULTS....................................................................................................................... 41
Summary of papers I – IV .......................................................................................... 41
DISCUSSION................................................................................................................. 49
CONCLUSIONS ............................................................................................................ 59
ACKNOWLEDGEMENTS ........................................................................................... 60
REFERENCES ............................................................................................................... 61
PAPERS
This thesis is based on the following papers, which will be referred to in the
text by their Roman numerals
I.
Nilsson KG, Henricson A, Norgren B, Dalén T.
Uncemented HA-coated implant is the optimum fixation for the TKA
in the young patient.
Clinical Orthopaedics and Related Research 2006; 448: 129-39.
II.
Henricson A, Dalén T, Nilsson KG.
Mobile bearings do not improve fixation in cemented total knee
arthroplasty.
Clinical Orthopaedics and Related Research 2006; 448: 114-21.
III.
Henricson A, Linder L, Nilsson KG.
Trabecular metal tibial component in patients younger than 60 years.
A prospective RSA study.
Submitted 2008.
IV.
Gao F, Henricson A, Nilsson KG.
Cemented versus uncemented fixation of the femoral component of
the NexGen CR total knee replacement in patients younger than 60
years. A randomized RSA study. Submitted 2008.
1
ABBREVIATIONS
BMI Body Mass Index

MBK Mobile Bearing Knee
NG Nex Gen
NG CR NexGen Cruciate Retaining
OA Osteoarthrosis
PE Polyethylene
PMMA Polymethyl-methacrylate ( = bone cement)
RSA RadioStereometric Analysis
RA Rheumatoid Arthritis
SKAR The Swedish Knee Arthroplasty Register
TM Trabecular Metal
TM CR Trabecular Metal Cruciate Retaining
TMT Trabecular Metal Tibia
TKA Total Knee Arthroplasty
2
INTRODUCTION
History and development of total knee arthroplasty
Treatment of osteoarthrosis of the knee with total knee arthroplasty is an

established and reliable method. The first modern type of total knee
replacement was designed by Gluck, who 1890 presented a concept of
surface replacing with the use of ivory components attached to the bone with
a cement made of colophony, pumice and plaster of Paris. However, neither
the ivory or the cement could withstand the forces applied to the knee and
infection became a major problem.
The modern era of total knee replacement began with Gunston (1971) who,
influenced by the work of Charnley, in 1968 designed a surface replacing
prosthesis with a metal component articulating against a polyethylene
component and both components attached to the bone with bone cement
made of polymethyl-methacrylate (PMMA). The design was an
unicompartmental prosthesis suited for either the medial or the lateral
compartment or both. Freeman and Swanson (1972) designed an unlinked
total knee prosthesis of condylar type and inserted the first one in 1970.
Modifications of this design is still in clinical use as the Freeman-Samuelson
prosthesis. Insall worked with the same concept, and 1973 the Total
Condylar Knee was introduced (Insall et al. 1976a). This was a
semiconstrained prosthesis with the femoral component made of metal and
the tibial component of polyethylene. The femoral component had an
anterior flange for articulation against a polyethylene patellar component.
The tibial component was cup-shaped for stability, had an intercondylar
eminence and an intramedullary peg to enhance fixation. All components
were cemented. Short-term good results were reported 1979 (Insall et al.).
3
This concept is still considered to be “the gold standard” of total knee
arthroplasty.
Despite reasonably good results in the late 1970s, the failure rates in knee
arthroplasty were higher than in hip arthroplasty (Tew and Waugh 1982).
The major cause for failure was loosening of components, especially on the
tibial side (Moreland 1988). Biomechanical studies indicated that a metal
reinforcement of the polyethylene tibial component would lead to lower and
more evenly distributed stresses to the underlying bone and thus improved
fixation (Bartel et al. 1982, Reilly et al. 1982, Lewis et al. 1982). The designs
of total knee prostheses during the 1980s were therefore changed to metal-
backed tibial components and also to less conforming articular surfaces in
order to decrease forces acting on the implant-bone interface.
Despite improved results, there were still some problems. The most common
reason for revision during the 1980s was still component loosening (Knutson
et al. 1994). Several reports of negative effects of the bone cement such as
heat injury (Mjöberg 1986) and chemical toxicity ( Stürup et al. 1994)
resulting in bone resorption and osteolytic activity ( Fornasier et al. 1991,
Schmalzried et al. 1992, Bos et al. 1995) led to a search for alternative fixation
methods. Uncemented designs were developed as press-fit implants either of
polyethylene (Blaha et al. 1982) or with metal backing coated with porous
layers in order to achieve bony ongrowth or ingrowth (Hungerford et al.
1989) often enhanced with screw fixation ( Rosenberg et al. 1990). Although
good results were reported with uncemented implants (Hofmann et al. 2001),
no superiority to cemented designs could be detected (McCaskie et al. 1998).
RadioStereometric Analysis (RSA) investigations revealed no differences in
migration between cemented and uncemented implants in some studies
(Nilsson et al. 1991, Toksvig-Larsen et al. 1998), but showed increased tilting
of uncemented components in others ( Nilsson and Kärrholm 1993). In fact,
4
some authors found higher revision rates with uncemented prostheses
(Robertsson et al. 1997, Duffy et al. 1998, Berger et al. 2001b) and Lachiewitz
(2001) stated that cemented total knee arthroplasty is the gold standard.
Therefore, a turning back to cemented concepts ensued.
Further development of designs in order to improve fixation of the
components came about. The concept of mobile bearing total knee
arthroplasty, which theoretically would uncouple the forces acting on the
implant-bone interface and thus improve fixation was developed early
(Goodfellow and OĆonnor 1986, Buechel and Pappas 1986) and good
results have been reported ( Buechel 2004, Callaghan et al. 2005, Tarkin et al.
2005). Coating the porous layer at the undersurface of components with
hydroxy-apatite (HA) have been shown to enhance fixation of implant to
bone (Regnér et al. 1998, Önsten et al. 1998, Nelissen et al. 1998, Toksvig-
Larsen et al. 2000). Novel material for implant coating have been developed
i.e. trabecular metal (Bobyn et al. 1999a).
In general, the results of total knee arthroplasty in long-term reports are very
good with prosthetic survival rates of 92–99 % at 14–17 years (Font-
Rodriquez et al. 1997, Gill and Joshi 2001, Keating et al. 2002).
The increasing need of total knee arthroplasty in younger patients (Laskin
2002) and the higher revision rates in these patients (Furnes et al. 2002,
Harrysson et al. 2004) constitutes the challenge today to develop concepts of
knee replacement that will have a longevity of at least 25 years.
To my knowledge there are no randomized studies and indeed no high
resolution (as RSA) studies in the literature concerning younger patients.
This thesis will investigate various factors that potentially may improve the
results of TKA in younger patients.
5
Factors related to prosthetic fixation
Patient related factors
Age
The prevalence of osteoarthrosis is increasing in patients in their 50s and 60s
presumably as a result from a change of life-style with more physically
demanding leisure-time activities and organized sports activities leading to
more injuries to the anterior cruciate ligament, the menisci and the articular
surfaces (Laskin 2002). This increase of osteoarthrosis is in turn leading to an
increasing need and demand for total knee replacement (Robertsson et al.
2000, Laskin 2002, Ritter 2002). The life-style with higher activity level in this
age group will inevitably put higher stresses to the implants and to implant
fixation. The challenge today is therefore to design TKAs with a longevity of
25 years or more.
The results of TKA in younger patients are varying. Many reports show good
results (Dalury et al. 1995, Gill et al. 1997, Hofmann et al. 2002, Morgan et
al. 2007, Whiteside and Viganò 2007) but they involve relative small numbers
of patients, have mid-term follow-ups and mixed diagnoses making it hard to
draw any extensive conclusions. In long-term follow-ups of patients with OA
Diduch et al. (1997) and Duffy et al. (2007) present 10-year survival rates of
94-96 % concerning revision for loosening of components. However, Duffy
et al. (2007) had several revisions due to wear and osteolysis in the second
decade leading to a decreased survivalship of 85 % at 15 years. Crowder et al.
(2005), in patients with RA younger than 55 years, reported a 94 % survival
rate at 20 years. In larger cohorts, the results of TKA in younger patients are
inferior. Gill and Joshi (2001) found, in a long term study of cemented
TKAs, a revision rate in patients younger than 55 years of 21 % compared to
3 % in patients older than 55 years. Gioe et al. (2007) report from a
community register in patients younger than 55 years with knee replacement
6
of different designs a 14-year survival rate of 74,5 % compared to 85 % for
the cemented TKAs. The large Scandinavian knee arthroplasty registers show
significantly higher revision rates in younger patients (Robertsson et al. 2001,
Furnes et al. 2002). When comparing 1,434 patients aged below 60 years with
21,761 patients aged 60 years or more Harrysson et al. (2004) found a more
than twice as high revision rate in the younger patient group. Analysing
loosening of components as the cause of revision, the rate was 6 % for the
younger group and 2.5 % for the elder group.
It seems as if patients younger than 55 to 60 years have higher revision rates

than the elderly patients. The main problem is obviously component
loosening and thus fixation of components to bone. Studies of implants with
presumably more reliable concepts of fixation in younger patients are
therefore desirable. To my knowledge there are no reports in the literature of
randomized studies of such TKAs in patients younger than 60 to 65 years.
Diagnosis
OA (osteoarthrosis) or RA (rheumatoid arthritis). The incidence of total knee

arthroplasty in Sweden is 10 times higher in OA patients than in RA patients
(Robertsson et al. 2000). RA patients generally receive a total knee
arthroplasty at younger age (mean 7 years) than do patients with OA
(Robertsson et al. 2001). RA patients have an inferior bone quality compared
to OA patients, which presumably would affect the results after total knee
arthroplasty negatively. However, RA patients have a more sedentary way of
living with lower activity level. Weir et al. (1996) found, in a 12-year
follow-up, no difference in survivorship of knee replacement between OA or
RA. On the other hand did Gill and Joshi (2001) find a better prognosis in
OA than in RA in a 10-year follow-up. In a study of a large cohort (more
7
than 11,000 knees), Rand et al. (2003) found a significantly lower revision
rate for RA patients which corroborates the findings of the Swedish Knee
Arthroplasty Register (SKAR) (Robertsson et al. 2001). In SKAR, OA
patients had a 1.3 times higher risk for revision than RA patients. The risk of
infection is, however, higher in RA patients (Moreland 1988, Robertsson et
al. 2001). In patients younger than 55 years Ritter et al. (2007) found lower
revision rate in RA patients than in OA patients.
RA patients, who often are younger than OA patients, seem to have better
results than OA patients. There are few reports concerning patients younger
than 60 to 65 years and no randomized studies dealing with differences
between the diagnoses.
Weight
The definition of obesity is when the body mass index (BMI) is greater than
30. Morbid obesity is present when the BMI is over 40. The incidence of
obesity is slowly increasing in western countries and thus more obese patients
are being considered for total knee arthroplasty. The higher stresses put on
an implant carrying higher weight are assumed to result in more wear and
loosening of components.
In a large long-term follow-up study the success rate of TKA was not
influenced by weight (Font-Rodriques et al. 1997). Spicer et al. (2001) found
similar 10-year survivalship for both obese and non-obese patients. Focal
osteolysis was, however, more common in the morbidly obese. Comparing a
group of obese patients with a matched group of non-obese patients Foran et
al. (2004a) demonstrated lower Knee Society Score for any degree of obesity
and a higher revision rate in the morbidly obese. The same research group
(Foran et al. 2004b) found a higher failure rate in obese patients after TKA,
8
but this did not became apparent until after 14 years, which strongly
emphasises the need for long-term follow-ups in joint replacement surgery.
The postoperative infection rate in highly obese (BMI>35) patients was 6.7
times higher after knee arthroplasty accordning to Namba et al. (2005). A
lower Knee Society Score, a higher incidence of radiolucent lines, a higher
rate of complications (infection, deep-vein thrombosis) and an inferior
survivorship in morbidly obese patients with knee arthroplasty was found by
Amin et al. (2006). Krushell and Fingeroth (2007) found higher rates of
wound complications, suboptimal alignment and late revision in morbidly
obese patients.
The risk of complication and inferior result after total knee arthroplasty
seems higher in obese patients, especially in the morbidly obese. Therefore it
is recommendable to advise obese patients to lose weight prior to TKA (and
then keep it) in order to minimize detrimental complications. In randomized
studies you are trying to avoid outliers due to extreme inclusion values and
therefore it is common to set an upper limit of weight. No specific studies of
younger obese patients have been found in the literature.
Gender
The male to female ratio among patients receiving a TKA is 1:2 in patients
with primary OA and 1:3 in RA patients (Robertsson et al. 2001). Several
studies have shown no influence of gender concerning revision rates (Font-
Rodriques et al. 1997, Gill and Joshi 2001). In SKAR there was no difference
in OA patients, but a higher revision risk for men in RA patients (Robertsson
et al. 2001). Rand et al. (2003) found inferior overall survivorship at ten years
for men. Women generally have more pain and disability prior to surgery and
9
also greater disability after TKA, but report postoperative global health
scores (i.e. SF-36) similar to men (Hawker et al. 1998).
Prosthesis factors
The tibial component

In the beginning of the modern era of total knee replacement the tibial
component was made of all-polyethylene and fixed to the bone by bone
cement (PMMA) (Gunstone 1971, Freeman and Swanson 1972, Insall
1976a). In these early TKAs the articular surfaces were highly conforming.
Total knee arthroplasty is fully conforming when the radii of the femoral and
the tibial components are identical. The greater the radius of the tibial
component articular surface, the less conforming becomes the TKA. High
conformity enhances the stability of the joint and produces a large area of
contact between the components when loaded (Colizza et al. 1995). A large
contact area means less point pressure and less intermittent eccentric loading
of the polyethylene component and thus decreased risk of polyethylene wear.
The disadvantage of this design is the constraint of the construction leading
to transfer of the rotational and translational forces of the articulation to the
implant-bone interfaces and hence loosening of components (Werner et al.
1978). Low conforming TKAs are less constrained allowing more rotational
and sliding movements at the articulation with kinematics more similar the
normal knee. The disadvantage is a risk for eccentric loading of the tibial
component with small areas of high pressure leading to stress of the interface
and an increased risk of polyethylene wear (Bartel et al. 1982). The optimum
degree of conformity is not known and the tendency in modern TKAs is a
moderately conforming articulation.
10
Lower stresses to the cancellous bone beneath the tibial component when
the component was reinforced with a metal tray was found in a finite-
element study by Bartel et al. (1982). Lewis et al. (1982), also using a finite-
model analysis, showed that the lowest stresses to the cement-bone interface
were found in a single-post, metal-backed tibial component. A cadaver study
gave the same result with lower interface shearing forces beneath metal-
backed tibial components than beneath polyethylene components (Reilly et
al. 1982). These reports together with the problem of loosening of the tibial
components (Moreland 1988) led to a change to metal-backed tibial
components. Furthermore, metal-backed components could act as a heat
sink (Mjöberg 1986) and lower the temperature during cement
polymerisation, which presumably would decrease the thermal necroses in
bone and thereby reduce the fibrous tissue layer. Other proposed advantages
with metal-backing was the ability to add stems, wedges and blocks and the
concept of modularity, which facilitated exchange of the polyethylene insert
in case of instability or polyethylene wear without having to remove the
entire tibial component from the bone.
In searching for reasons of component loosening in TKA many researchers
focused on the bone cement (PMMA) and its properties. Histiologic studies
of stable implants revealed increased osteoclastic activity in the vicinity of the
fibrous membrane at the implant-bone interface (Fornasier et al. 1991),
evidence of bone resorption at the implant-bone interface (Schmalzried et al.
1992), and histiocytic infiltration in the cancellous bone adjacent to the
fibrous membrane (Bos et al. 1995). Toxic effects of bone cement on bone
perfusion and remodelling were found in a canine study by Stürup et al.
(1994). Negative effects on bone tissue from the heat emerging from the
cement when curing was shown by Mjöberg (1986).
11
The condition “cement disease” was proposed by Jones and Hungerford
(1987) and in order to avoid any detrimental effects of bone cement,
experiments with porous materials coated on metal started. With sintered
fiber titanium composites Galante et al. (1971) showed bony ingrowth
already after 2 weeks in rabbit and dog femora. They concluded that a fiber
metal composite bonded to a solid metal core would provide fixation to bone
and uniform stress distribution at the implant-bone interface. The concept
with porous coating of implants, with the assumption of increased longevity
and thus more suited for younger patients, became widely used either as
sintered fibers or sintered beads of metal, and showed promising results in
short-term follow-ups (Hungerford et al. 1989, Dodd et al. 1990). Additional
effects of uncemented replacements are shortened operating time and an
improved possibility to retain the components in case of infection, because
there is no avascular implant-bone interface (Cross and Parrish 2005).
A higher revision rate in uncemented TKAs compared to cemented TKAs
was reported by Duffy et al. (1998), Rand et al. (2003) and Cloke et al. (2008).
Reviewing several reports of uncemented knee prostheses Lachiewics (2001)
found significantly higher rate of component loosening and osteolysis
compared to cemented concepts and stated that a cemented
tricompartmental arthroplasty remained the gold standard. However,
excellent long-term results with prosthetic survival of 98-99 % at 18-20 years
was reported by Buechel et al. (2001) and Whiteside (2001) using cementless
prostheses.
Concerning younger patients operated with uncemented knee arthroplasty
Hofmann et al. (2002), in a study of patients younger than 50 years with mid-
term follow-up, found good clinical results and no revision for loosening of
components. Long-term follow-up studies have shown increased incidence
of failures with uncemented TKAs in patients younger than 55 years (Gioe et
12
al. 2007) and 60 years (Cloke et al. 2008), respectively. In several randomized
studies have no differences between cemented and uncemented TKAs been
revealed concerning clinical parameters (Nilsson et al. 1991, Nilsson and
Kärrholm 1993, Önsten et al. 1998, McCaskie et al. 1998).
The prerequisite for bony ingrowth is initial stability and it was shown that
uncemented tibial baseplates secured with four cancellous screws had the
greatest initial stability (Voltz et al. 1988, Lee et al. 1991). Securing the tibial
tray with screws was also found to achieve the highest extent of bony
ingrowth compared to trays with pegs but without screws (Sumner et al.
(1994). This concept became widely spread and screw fixation of the tibial
component was considered “the gold standard” in uncemented fixation.
However, screw fixation turned out to be associated with osteolysis around
the screws and the screw holes. In mid-term studies, osteolysis around the
screws were found in 16-22% of cementless tibial trays ( Peters et al. 1992,
Lewis et al. 1995, Goldberg and Kraay 2004). In a long-term follow-up study,
finding a rate of tibial component aseptic loosening of 8% and 12%
incidence of osteolytic lesions, Berger et al. (2001b) stated that they have
abandonded cementless fixation. Nevertheless, some studies with screw-
fixated uncemented tibial components have revealed good results. Watanabe
et al. (2004) showed a 97 % survival at 13 years and Whiteside and Viganò
(2007) found no loosening of components in a mid-term follow-up of
patients younger than 55 years.
Covering the porous coating in cementless prostheses with hydroxy-apatite
(HA) by a plasma spray technique has proved to enhance the ability of bony
ongrowth in implants (Søballe et al. 1999). The positive effect of HA coating
on implant-bone fixation works in both stable and unstable mechanical
situations. Furthermore, it was found that bone growth across a gap was
enhanced by HA and thus HA coating had a capacity of sealing defects
13
(Rahbek et al. 2000). One retrieved HA-coated tibial component two years
postoperatively was examined histio-morphometrically by Akizuki et al.
(2003) and the tissue within the porous coating of the tray and the pegs were
bone in 81 %. The interface consisted of 78 % bone, 21 % marrow and 1 %
fibrous tissue.
Several randomized studies using RSA have shown superior results of HA
coated implants compared to non-HA coated porous or fiber mesh coated
implants or to cemented implants. Migration was less in HA coated fiber
mesh tibial trays compared to a fiber mesh coated tray with no HA in studies
by Regnér et al. (1998) and Nelissen et al. (1998). When comparing the
migration of cemented tibial implants with HA coated implants, Toksvig-
Larsen et al. (2000) found a strong positive effect of the HA coating on the
fixation of the tibial component. Several randomized RSA studies with 5-year
follow-up have been published. Nilsson et al. (1999) showed that the
magnitude of migration did not differ between uncemented HA coated and
cemented tibial implants. However, the pattern of migration differed, the HA
coated implants displayed most of the migration within the initial 3 months
and then stabilized, while the cemented implants continued to slowly migrate
over time. Comparing HA coated tibial trays with porous coated trays,
Regnér et al. (2000) found less migration and less inducible displacements of
the HA coated implants. The patients in the study by Önsten et al. (1998)
were evaluated 5 years postoperatively (Carlsson et al. 2005) and the
magnitude of migration was less for cemented tibial implants compared to
HA coated implants, however, the HA coated implants stabilized within 6
months while the cemented implants showed continuous migration.
There are few long-term reports of HA coated prostheses. A prospective
analysis of 1429 knees followed a mean of 6.6 years revealed only one
revision for aseptic loosening and a 10-year survival rate of 99% (Cross and
14
Parish 2005). In a later analysis of 118 knees in patients younger than 55
years they found 2 aseptic loosenings of the tibial component and an overall
12-year survival of 92% (Tai and Cross 2006).
New materials for uncemented fixation have been developed. Trabecular
metal has several theoretical advantages (Bobyn et al. 1999a, Zhang et al.
1999, Florio et al. 2004) that will be thoroughly discussed in a separate
chapter in this thesis.
In general, it seems that uncemented concepts are afflicted with problems

leading to inferior results, especially in younger patients. Coating the implants
with HA, however, seems to enhance the quality of implant-bone fixation
leading to improved results in both clinical follow-ups and RSA studies. Few
reports are found concerning younger patients with HA coated implants and
none using the RSA technique. Wether screw fixation of tibial base plates
results in improved fixation has not been the object of any RSA study in
younger patients. There are only sparse short-term reports of trabecular
metal tibial implants and no study in younger patients.
The femoral component

Aseptic loosening of the femoral component is less frequent than of the
tibial component, but nevertheless a problem. In a multicenter cohort of
revised TKAs Mulhall et al. (2006) reported that femoral component
loosening constituted one third of the TKAs that were revised because of
loosening. The authors did not specifically state wether the components were
cemented or uncemented. Other reports in the literature have come to
different conclusions.
Concerning cemented femoral components long-term follow-ups revealed no
loosenings at all (Schai et al.1998, Berger et al. 2001a). Keating et al. (2002)
found a revision rate of the femoral component of 0.18% compared to
15
0.46% of the tibial component. In mid-term studies of cemented femoral
components, Chockalingam and Scott (2000) and Lachiewicz and Soileau
(2006) found very few loosenings.
Uncemented femoral components have performed very well with no
loosenings in long-term studies by Schröder et al. (2001), Berger et al.
(2001b) and Whiteside (2001). On the other hand Campbell et al. (1998) and
Chockalingam and Scott (2000) found pronounced problems in mid-term
follow-ups with revision rates of uncemented femoral components of 9-
10%. Goldberg and Kraay (2004) found 17% femoral osteolysis in a long-
term follow-up. Occasional femoral loosening in a long-term study has been
reported by Tarkin et al. (2005).
HA coating of the femoral component has proved successful with no
femoral loosenings in a mid-term study by Cross and Parish (2005) and in a
long-term study concerning patients younger than 55 years (Tai and Cross
2006). Only two studies of femoral component fixation using RSA are found
in the literature. Nilsson et al. (1995) studied the Miller-Galante I prosthesis
and found no difference in migration between cemented and uncemented
implants at 2 years follow-up. Uvehammer et al. (2007) used the Freeman-
Samuelsson prosthesis of three different designs randomized to receive either
a cemented or a HA coated femoral component and found that the rotations
around the three cardinal axes did not differ between the different modes of
fixation.
The optimum mode of fixation of the femoral component seems unclear.

Almost all earlier studies of femoral component fixation are done in elderly
patients. To my knowledge there are no randomized studies of femoral
fixation in younger patients.
16
Mobile bearing TKA
A successful total knee arthroplasty should fulfil three important criteria;

freedom of pain, stability and mobility. Movements of the normal knee
include not only flexion and extention, but also rotations around the other
two cardinal axes and translations along all three cardinal axes. In order to
reduce polyethylene wear, improve the kinematics of the artificial knee and
lower the risk of tibial component loosening, Goodfellow and OĆonnor
(1986) developed a tibio-femoral artificial joint with a meniscal bearing
(mobile bearing TKA), which was first implanted 1976 . This design consists
of a convex spherical metal femoral component and a flat metal tibial
component. Free meniscal bearings of polyethylene are placed between the
metallic components. The bearings are spherically concave above, flat below,
and held in place by their geometry. They can rotate and slide at the tibio-
meniscal articulation, and the menisco-femoral articulation is fully
conforming. This implant was designed as an unicompartmental knee
replacement. This concept of mobile bearing TKA was soon followed by
others. Bicompartmental mobile bearing TKA with two meniscal bearings
medially and laterally was introduced 1977 by Buechel and Pappas (1986). A
mobile bearing TKA with one meniscal bearing covering the entire tibial
plateau was also developed by Buechel and Pappas (1986). Different designs
of mobile bearings offer different mobility of the bearing, some designs only
rotate, others rotate and have some anterior-posterior translation, and some
are unconstrained.
The kinematics of a normal knee includes posterior femoral roll-back of the
lateral condyle and internal axial rotation during flexion (Komistek et al.
2003). Studies with in vivo fluoroscopic examinations of different fixed
17
bearing TKAs have shown reductions of the posterior femoral roll-back and
axial rotation, femoral condylar lift-off, reversed axial rotational patterns and
even a paradoxical anterior femoral translation during deep flexion (Dennis
and Komistek 2006). Normal rotation is needed for optimal patellar tracking
and optimal flexion in the knee. In mobile bearing total knee arthroplasty the
paradoxal anterior femoral translation is reduced (Dennis 2005). In a
kinematic study, D´Lima et al. (2000) found that the normal tibial rotation
during extension was significantly changed in a fixed bearing total knee
arthroplasty, while a mobile rotating meniscal bearing TKA had minimal
effect on tibio-femoral kinematics.The main rotational motion occurs at the
inferior aspect of the mobile bearing with minimal motion between the
femoral component and the polyethylene insert (Komistek et al. 2004). This
pattern theoretically uncouples the forces at the interface between the tibial
component and the bone and thereby reduces the risk for aseptic loosening.
The compressive strain in the proximal tibia during axial loading and rotation
was reduced by 68-73% in a mobile bearing TKA compared to a fixed
bearing TKA, suggesting a more stable implant-bone interface of the mobile
bearing concept (Bottlang et al. 2006). The contact stress of a mobile bearing
implant is substantially lower than in a fixed bearing implant, both
experimentally (Tsakonas and Polyzoides 1997, Matsuda et al. 1998,
Stukenborg-Colsman et al. 2002) and in vivo (Sharma et al. 2007). Wear rates
of meniscal bearings have been shown to be very low compared to fixed
bearings (Tsakonas and Polyzoides 1997) and annual penetration rates lower
than those of the Charnley hip have been found by Argenson and O`Connor
(1992) and Psychoyios et al. (1998).
The ability to move and thus the ability of self-adjustment of the mobile
bearing in order to improve the kinematics of the artificial knee have been
under debate. Movements of mobile bearings in vivo have been
18
demonstrated by Stiehl et al. (1997), Fantozzi et al. (2002) and Hansson et al.
(2005). No decrease in magnitudes of rotation of mobile bearings between 3
and 15 months was found by Komistek et al. (2004) indicating that soft tissue
scarring and encapsulation of the bearing did not occur.
Follow-ups of mobile bearing TKAs have shown similar clinical results as
fixed bearing TKAs. Survival rates of 90-98 % at 12-20 years with only
occasional aseptic loosenings of the tibial component have been reported by
Buechel (2004), Sorrells et al. (2004), Callaghan et al. (2005), and Tarkin et al.
(2005). In a cohort of young patients (mean 51 years) Morgan et al. (2007)
found excellent clinical results and no aseptic loosening using a mobile
bearing TKA in a mid-term study. In a randomized short-term study by
Aglietti et al. (2005) no clinical differences between fixed or mobile bearing
total knee arthroplasty were found. There is only one randomized study with
mobile bearing TKA using RSA (Hansson et al. 2005). The authors found
no differences between an uncemented mobile bearing TKA and an
uncemented fixed bearing TKA regarding clinical results, migration or
inducible displacement at 2 years follow-up.
The results of mobile bearing TKA are similar to the results of fixed bearing
TKA. There is no evidence of superiority of the mobile bearing concept
despite theoretical advantages. To my knowledge there is no randomized
study published comparing a cemented mobile bearing TKA with a cemented
fixed bearing TKA using high-resolution technique.
Trabecular metal
Tantalum (Ta) has been in clinical use since before 1940. The most common
applications have been as radiographic marker (Ta powder), for example in
the lungs or in the brain, as vascular clips and stents, and as repair of cranial
19
defects. Ta is quite chemically stable, oxidizing in air at 300 °C, and has an
excellent corrosion resistance, being attacked only by strong acids and alkalis
(Black 1994). When implanted as foil, wire, rod or ball in bone, there is
significant evidence that it can become osteointegrated. Matsumo et al.
(2001) implanted tantalum wires into subcutaneous tissue and into bone
marrow in rats and found good biocompatibility and osteconductivity. In the
subcutaneous tissue, there was no inflammatory response and no detectable
dissolution of the metal. Histological examination of the bone tissue showed
slightly decreased amount of bone formation from the second to the fourth
week, but signs of maturation of the bone were more evident at 4 weeks than
at 2 weeks. Over the same period, a markedly increasing percentage of bone
in contact with the implant were found.
Porous tantalum (trabecular metal) is manufactured by thermal reduction of a
polyurethane foam precursor to form a low-density vitreous carbon skeleton
which has a repeating dodecahedron array of pores. Pure tantalum is
deposited into and around the carbon skeleton using chemical vapour
deposition and infiltration to create a porous metal construct. The typical
thickness of the tantalum coating is 50 µm. The volume porosity is 75 % to
80 %, which is 2-3 fold greater than conventional porous materials and close
to the porosity of trabecular bone (Bobyn et al. 1999a). The elastic modulus
is about 2.5-4.0 GPa, similar to subchondral bone. For comparison titanium
has an elastic modulus of 110 GPa. The compressive strength of porous
tantalum is 50 – 80 MPa . The compressive strength of other porous
materials ranges from 3 – 150 MPa, for example trabecular bone (10 –50
MPa), cortical bone (130 – 150 MPa), and other porous metals (20-150 MPa).
Bobyn et al. (1999a) inserted cylindrical implants of trabecular metal into the
femoral diaphysis of mature mongrel dogs. They noticed by histological
examination that the pores of the implants were filled with new bone (to
20
40% to 50%) in four weeks. By 16 to 52 weeks, they noticed bone ingrowth
from 63% to 80%. Pull out tests of the implants revealed that half of the
implants at 4 weeks and all or the implants at 16 weeks showed compressive
failure before rupture of the implant-bone interface indicating a very strong
bond of the implant to bone.
Because of these interesting properties, trabecular metal has recently been
introduced into orthopeadics in the form of acetabular and tibial implants
intended for uncemented use. In these implants, the polyethylene is attached
to the metal by a direct compression moulding process that infuses the
polyethylene into the trabecular metal with an uniform penetration of
approximately 1.5 mm.
In an animal study, Bobyn et al. (1999b) used porous tantalum acetabular
monoblock cups in total hip arthroplasty in dogs. They found that all 22
acetabular implants had stable implant-bone interfaces with regions of bone
ingrowth present in all histologic sections. The depth of bone ingrowth
varied from 0.2 mm to 2 mm and the mean ingrowth for all sections were
16.8 %. Hacking et al. (2000) inserted porous tantalum into the subcutaneous
tissue in dogs and found an attachment strength that was three- to six-fold
greater than a similar experiment with porous beads. Histogical analysis
revealed complete tissue ingrowth through the implant with
neovascularization within the porous tantalum material. The gap healing
ability of trabecular metal was excellent in a study where implants of
trabecular metal and solid titanium with a glass bead blasted surface were
inserted into the femoral condyles of the canine knee (Rahbek et al. 2005).
The implants were inserted either with exact surgical fit or with a peri-
implant gap. Both implants with surgical fit and with peri-implant gap
showed superior bone ongrowth in the trabecular metal group compared to
21
the solid blasted titanium group. In fact, the trabecular metal implants with
peri-implant gap had significantly higher bone ongrowth
than the solid blasted titanium implants with exact surgical fit.
In an experimental model Zhang et al. (1999) found a very high friction
coefficient of porous tantalum material in comparison to natural bone
autografts or allografts, and to conventional orthopaedic coating materials.
The advantage of initial stability of an implant in uncemented designs is
important and a high friction coefficient would presumably enhance the
possibility for bony ingrowth or ongrowth. Florio et al. (2004) compared the
flexibility of porous tantalum monoblock tibia and a stemmed titanium
modular tibia and found higher flexibility of the tantalum component. This
property could theoretically decrease load transfer to the interface and
thereby reduce stress shielding.
Clinical reports of trabecular metal implants are sparse. Gruen et al. (2005)
followed 414 cases of trabecular metal acetabular cups (mean 33 months).
Postoperative radiographs revealed acetabular gaps in 19 % of the hips. At
the last follow-up 84 % of these gaps were completely filled in. In a
radiological follow-up (mean 7 years) of 86 hips Macheras et al. (2006) found
that all postoperative gaps had disappeared after 24 months. No component
migration was found using the EBRA digital measurement method. There
are only few short-term reports in the literature regarding trabecular metal
tibial implants. Bobyn et al. (2004) reported a 2-year follow-up of 72
uncemented TMT implants. At the last follow-up there were no new or
progressive radiolucent lines and no revisions. When comparing a group
TKAs using a TMT with a group of standard cemented TKAs Ghalayini and
McLauchlan (2004) found no clinical differences at a follow-up of 13
months. Bal et al. (2006) followed 115 total knees with a TMT implant for a
minimum of 12 months and found no complications at all. There is only one
22
randomized study using RSA reported (Dunbar et al. 2007). They found no
difference in micromotion at 1 year between a group of TMT implants and a
group of fixed bearing TKAs. The TMT implants had a greater initial
migration, but seemed to stabilize at 6 months postoperatively.
The properties of trabecular metal are close to normal bone and animal
studies have shown evidence of bony ingrowth. Theoretical considerations
indicate that this concept would enhance the fixation of implants to bone
and thus be well suited for total knee arthroplasty in younger patients.
Clinical reports are, however, few and no histiological examinations of
implants from humans have been published. No long-term studies are
reported and indeed no studies in younger patients.
Radiostereometric analysis (RSA)
All studies in this thesis are based on the RSA method. The system of RSA
was introduced by Selvik (1989). It has been in use for more than 25 years.
RSA is a high-resolution method with the largest accuracy to measure
micromotion in vivo. The method can be performed with an in vivo accuracy
of 50-250 µm and 0.1-0.6º (Kärrholm 1989). Implantation of tantalum
markers into the bone and the implant is required. The markers constitute
two rigid bodies and the three-dimensional co-ordinates of these are
determined by repeated x-ray examinations using a calibration cage and two
angled x-ray tubes. The relative motion of the implant in relation to the bone
over time can then be computed. The applications are numerous in the
orthopaedic field (Kärrholm 1989). The method has a possibility to predict
future loosening of implants (Kärrholm et al. 1994, Ryd et al. 1995) and is
23
recommended to asses aseptic implant loosening (Nilsson and Kärrholm
1996).
Surgical technique
In order to avoid asymmetric loading leading to stress of the implant-bone
interface with increased risk of loosening, it is crucial to obtain a stable knee
with normal alignment when performing a total knee arthroplasty.
Besides from meticulous surgery when making the bone cuts, this is
achieved by careful and adequate soft tissue release (Freeman et al. 1978).
Malalignment is a risk factor for component loosening and the surgeon
should aim at an alignment close to neutral or in slight valgus (Ritter et al.
1994).
All knees in this thesis were operated according to modern standard
procedures and performed by three very experienced knee arthroplasty
surgeons.
24
The need of total knee arthroplasty in younger patients is increasing, but the
results are inferior and thus it is desirable to search for improved modes of
fixation of components. Coating uncemented implants with hydroxy-apatite
seems to improve fixation. There are no studies using RSA of HA coated
TKAs in younger patients. Enhancing the tibial base plate with screws
theoretically strengthens the fixation, but detrimental side effects as osteolysis
around the screws have been reported. Wether screw fixation of HA coated
tibial components reveals improved fixation in younger patients has not been
studied. The concept of mobile bearing TKA theoretically uncouples the
forces at the implant-bone interface, which presumably would enhance the
fixation of the implant to bone. One RSA study of mobile bearing TKA is
published concerning an uncemented design. There is no RSA study of the
tibial fixation of cemented mobile bearing TKAs in the literature.
Trabecular metal tibial components have several theoretical advantages that
would improve implant fixation and thus suit the younger patient. No study
of trabecular metal tibia in younger patients have been published. The best
method of fixating the femoral component in younger patients is yet to be
established. Uncemented fixation has not been evaluated in younger patients
using RSA.
25
AIMS OF THE STUDY
- to evaluate the magnitude and pattern of migration of a mobile

bearing cemented total knee prosthesis and to compare with a fixed
bearing TKA.
- to compare the migration pattern and magnitude of an uncemented

hydroxy-apatite coated modern designed total knee prosthesis with or
without tibial screw fixation and a cemented total knee prosthesis of
the same design in patients younger than 65 years.
- to evaluate the migration pattern of uncemented trabecular metal tibial

implants in patients younger than 60 years.
- to compare the quality of fixation of cemented versus uncemented

fixation of the femoral component in patients younger than 60 years .
26
MATERIAL
Patients
The entire material consists of 196 knees in 173 patients operated on
between April 1997 and February 2005. The diagnosis were primary
osteoarthritis (study II), primary or secondary osteoarthritis (studies I, III
and IV) or rheumatiod arthritis (study I). Forty-one patients (47 knees)
participated in both studies III and IV. The patients were consecutively
selected from the waiting list at the department of Orthopaedics, Umeå
University Hospital (study I), and the department of Orthopaedics, Falu
General Hospital (studies II, III and IV)
Exclusion criteria were previous infection, malignant disease, severe
osteoporosis and in study II also previous ipsilateral surgery. All studies in
this Thesis were approved by the Ethics Committees of Uppsala University
(studies II, III, IV) and of Umeå University (study I). Patients fulfilling the
inclusion criteria entered the studies after having been informed verbally and
in writing and had given their written consent. All eligible patients agreed to
participate.
Patients with incomplete follow-up
Ten patients in study I were not available during their summer vacations and
could thus not be followed up clinically or with RSA at 6 weeks. One patient
in study I (in the no screws group), could not be analysed by RSA at all due
to too few visable markers.
In study II, one patient in the MBK group died in myocardial infarction 2
weeks postoperatively and thus could not be followed up. Another patient
27
also in the MBK group, refused to attend the 2-year follow-up because of
poor general health and thus have no RSA and clinical data at 24 months.
In study III, the postoperative RSA in one patient in the TM CR group
examination failed and hence no further analysis was possible. One patient in
the NG CR group could not participate in the clinical follow-up at 24
months due to Alzheimer’s disease. One patient in the TM CR group was
revised after 19 months.
In study IV, the postoperative RSA examination in one patient in the
uncemented group failed and no further analysis was possible and another
patient in the same group could not participate in the clinical follow-up at 24
months due to Alzheimer’s disease. A third patient also in the uncemented
group, was revised at 19 months.
Patients with imperfections in the RSA examinations are listed in table 1.
Table 1. KNEES with incomplete follow-up due to RSA imperfections.
Poor RSA radiographs or too few markers visible

Study 3 months 6 months 12 months 24 months
Study I cemented 1 2 1 1
Study I HA coated, no screws 3 2 3 1
Study I HA coated, screws
Study II, fixed bearing
Study II, mobile bearing 2 1 1 1
Study III, cemented 1
Study III, trabecular metal
Study IV, cemented 4 4 5 5
Study IV, uncemented 2 2 2 3
At 6 weeks there were no RSA imperfections
28
Implants
The NexGen Option CR (NG CR) prosthesis (Zimmer, Warsaw, IN,

USA) (Figure 1) was used in studies II, III and IV. It is a moderately
conforming cruciate retaining, fixed bearing, and modular prosthesis for
cemented fixation. The femoral component is made of a Cobalt-Chromium-
Molybdenum alloy and the tibial base plate is made of Tivanium (Ti-6Al-4V)
alloy. The femoral component has an asymmetric configuration with a larger
radius laterally than medially (1.07-1.0) in order to facilitate normal femoral
rollback during flexion. The tibial component has a 50-mm long central stem
with small flanges projecting postero-laterally. The polyethylene (resin GUR
1050) insert is compression moulded and precision machined. It is gamma
sterilized in nitrogen gas. The insert is kept fixed to the tibial base plate with
a peripheral capture mechanism.
The porous coated femoral component (study IV) (figure 2) for uncemented
use is covered with a titanium fiber mesh undersurface.
The MBK prosthesis (Zimmer, Warsaw, IN, USA) (Figure 3) is a mobile

bearing cemented prosthesis used in study II. The tibial and femoral
components are made of a Cobalt-Chromium alloy and the upper surface of
the tibial implant is highly polished. The femoral component has a single
radius matching the highly conforming articular surface of the polyethylene
insert. Full contact occurs from 0° to 105° of flexion. The tibial base plate
has a 50-mm central stem with small flanges projecting postero-laterally. The
upper surface has a mushroom-shaped metal peg matching the mobile
polyethylene bearing, which is connected to the tibial base plate with a snap-
29
Figure 1. The tibial component of the NexGen Option CR prosthesis. The left picture shows the
tantalum markers encased in titanium rods.
Figure 2. The porous femoral component of the NexGen

Option CR prosthesis with tantalum markers encased in
titanium rods.
Figure 3. The MBK prosthesis
30
fit mechanism. The polyethylene component is from the same resin (GUR
1050) and is processed in the same way as the NexGen Option CR
polyethylene. The mobile bearing has a build-up in the center to prevent
medial-lateral translation of the femoral component. The mobile bearing
permits 25° of inward and 25° of outward rotation, and 4.5 mm AP
translation.
The Trabecular Metal CR (TM CR) (Zimmer, Warsaw, IN, USA) (Figure
4) prosthesis was used in study III. The Trabecular Metal Tibia (TMT) is a
monoblock implant with a base plate of trabecular metal. The base plate has
two hex-shaped pegs that can be press-fit into the tibial surface. The
polyethylene (GUR 1020) is compressed into the trabecular metal by a direct
compression moulding process. It is gamma sterilized in nitrogen gas. The
tibio-femoral conformity is almost identical with the NexGen Option CR
prosthesis.
Figure 4. The trabecular metal tibia.
The Profix (Smith & Nephew, Memphis, TN, USA) prosthesis is a modular,
moderately conforming cruciate retaining prosthesis and was used in study I.
The tibial trays are made of a 3-mm titanium alloy. The trays intended for
cemented use (Figure 5) has a grit-blasted undersurface with a keel shaped
stem. Trays for uncemented use (Figure 6) are porous coated with hydroxy-
apatite coating sprayed on. They have a short grit-blasted central stem and
31
Figure 5. The Profix prosthesis for cemented use. The grit-blasted undersurface to the right.
Figure 6. The Profix prosthesis for uncemented use without screws. The HA-coated
undersurface to the right.
Figure 7. The Profix prosthesis for uncemented use with screws. The HA-coated undersurface
to the right.
32
five tiny spikes. The trays intended for the use of screws (Figure 7) have four
screw holes, whereas the trays used without screws have no screw holes. The
polyethylene is made from GUR 1050 resin and sterilized with ethylene-
oxide.
Patellar components. In study I the patellar component was of the inset

type and made of all-polyethylene. The patellar component was used when
the patients had substantial osteoarthritis and a native patella with concave
articular surface. Five knees in the cemented group, eleven in the
uncemented group with no screws, and nine in the uncemented group with
screws had their patellae replaced.
In studies II, III, and IV the patellar components were of the onset type
and all-polyethylene and identical in shape for the NexGen Option CR, the
MBK, and the TM CR prostheses. The patella was resurfaced when the
patient had patellar symptoms and a concave articular surface of the patella.
In study II did five patients in the NexGen Option CR group and two
patients in the MBK group receive a patellar component. In study III, the
patella was resurfaced in three patients in each group. In study IV two
patients in the cemented group and four in the uncemented group were
resurfaced with a patellar component.
33
METHODS
Clinical evaluation
All patients were followed for 24 months with preoperative and

postoperative knee scores. The Hospital for Special Surgery Score (study I)
has been widely used (Insall et al. 1976b). This score incorporates a
functional component and will therefore deteriorate as the patients get older.
The Knee Society clinical rating system (Insall et al. 1989) (studies I, II, III,
IV) is divided into a knee score that scores only the knee joint and a
functional score that rates the ability to walk and climb stairs. The Knee
Society Knee Score assesses pain, range of motion and stability of the knee to
a maximum of 100 points. Substraction of points are made for flexion
contractures and radiographic malalignment. The Knee Society Function
Score is also maximized to 100 points with substraction when the patient
uses walking aid. The Knee Society Function Score estimates the function of
the patient as a whole, and in patients operated in both knees it is impractical
to use if one is interested in the performance of both knees independently.
Since many patients in studies III and IV were operated bilaterally, we used
the Knee Society Knee Score and the Knee Society Pain Score for their
evaluation, but not the function score.
Conventional radiography
The alignment of the knee in the frontal plane was measured as the Hip-
Knee-Ankle (HKA) angle (Moreland et al. 1987). A line between the center
of the femoral head and the midpoint of the tibial plateau forms an angle
34
with a line from the midpoint of the tibial plateau and the midpoint of the
talar plateau. The normal value of this angle is set to 180°. If this angle is less
than 180°, the knee is in varus malalignment, and if the angle is more than
180°, the knee is in valgus malalignment. The examinations of the HKA
angle were made preoperatively and at 3 months postoperatively.
The alignment of the tibial component in relation to the long axis of the tibia
was measured postoperatively in the frontal and sagittal planes as described
by Nilsson et al. (1991) (papers I, II, III).
The presence of radiolucent lines at the component interface were
determined on radiographs obtained with the beam tangential to the tibial
component according to the Knee Society (Ewald 1989). The size and
location of the radiolucent lines were documented and possible progression
of lines were analysed.
Randomization
The randomization process in studies I, II and IV was carried out by

opening of a sealed envelope during the operation. In study I the
randomization was between a cemented Profix prosthesis, an uncemented
Profix prosthesis without screws, and an uncemented Profix prosthesis with
screws. In study II the randomization was done between a standard NexGen
Option CR prosthesis and a MBK prosthesis. The randomization in study
IV was between uncemented femur and cemented femur. In study III the
intention was to randomize to surgeon in order to avoid any effects of
learning curve or surgeon’s bias. One surgeon (AH) with experience of
uncemented TKAs was planned to do the uncemented cases and another
surgeon, familiar with cemented TKAs should do the cemented cases.
However, the surgeon for the cemented cases had problems in recruiting
35
patients and therefore all patients were operated by the author in a
consecutive series in order to finish the study in a reasonable time.
RSA (Radiostereometric analysis)
During the operations, 7- 9 tantalum spheres (diameter 1.0 mm) were

implanted into the bone as radiographic markers. Care was taken to scatter
the markers widely in the bone. The implants (studies II, III and IV) were
equipped with tantalum markers (diameter 1.0 mm) encased in titanium
rods that were press-fit into the implant. The tibial plates in studies II and
III had 4 markers on the undersurface of the tray and one at the tip of the
stem. The femoral implants in study IV had 4 markers at the anterior and
posterior parts of the implant, respectively, and one marker on each peg. Six
tantalum markers (0.8 mm or 1.0 mm) were inserted into the polyethylene
component in studies I and III.
The patients were examined supine with the knee of interest positioned
inside a biplanar calibration cage (Cage 10, RSA Biomedical, Umeå, Sweden).
The anatomic axes of the knee were parallel to the cardinal axes of the
calibration cage at the initial reference examination. Two X-ray tubes were
positioned with an angle of 90° between each other and used for
simultaneous exposure. The initial RSA examinations were performed a
mean of 3 (±1.4) days postoperatively in studies I and II, and a mean of 4
(±1.6) days postoperatively in studies III and IV. Subsequent examinations
were done at 6 weeks, 3, 6, 12 and 24 months in study I, at 3, 12 and 24
months in study II, and at 6 weeks, 3, 12, and 24 months in studies III and
IV.
The RSA examinations were analysed using the UmRSA software (RSA
Biomedical, Umeå, Sweden). The two-dimensional position of the markers
36
were determined with the UmRSA Digital Measure and then reconstructed
into 3D-positions and 3D-motions with the UmRSA Analysis software. In
order to obtain similar positions on the tibial implants for translation
measurements in every implant, six standardized positions were
reconstructed on the tibial tray (Nilsson et al. 1991). Five of these positions
were located at the edge of the tibial tray medially, laterally, anteriorly,
posteromedially and posterolaterally, and one at the center of the tray. These
positions were plotted on the postoperative stereoradiographs and measured,
and their relation to the real markers in the polyethylene (study I, III [the
TMT implants]) or on the tibial tray (studies II, III) was calculated. Their
positions on subsequent examinations were then transferred using the Point
Transfer program in the RSA software using the implant markers as a
reference. The radiographs were mostly analogue in studies I and II and
were scanned using a UMAX PowerLook 2100 XL scanner (UMAX
Technologies, Dallas, TX, USA) with 300 dpi spatial resolution. During the
later parts of studies I and II and in all patients of studies III and IV the
radiostereometric radiographs were digital with 223 dpi spatial resolution.
The markers in the proximal tibia (studies I, II and III) and in the distal
femur (study IV) were used as a fixed reference segment. The relative
movements of the segment made up of the tantalum markers in the tibial
base plates and the femoral component, respectively, were calculated in
relation to the reference segments.
The quality of the RSA examinations is determined by the number of
markers, the condition number, and the mean error of rigid body fitting
(Valstar et al. 2005). The condition number is a measure of the quality of
dispersion of the markers in each segment and should be lower than 100.
Mean error of rigid body fitting is a measure of marker stability and should
37
not exceed 0.30. The values of the condition number and the mean error of
rigid body fitting are listed in table 2.
Table 2. Condition number and mean error of rigid body fitting
Study I II III IV
Condition number
Tibia or femur 27 29 33 63
Implant 21 20 24 37
Mean error of rigid

body fitting
Tibia or femur 0.19 0.22 0.16 0.23
Implant 0.13 0.13 0.09 0.09
The migrations of the implants were expressed as rotations around the

cardinal axes. Transverse rotation (X-axis) is anterior (+) – posterior (-),
longitudinal rotation (Y-axis) is internal (+) – external (-) , and sagittal (Z-
axis) is varus (+) – valgus (-). Lift-off and subsidence represent proximal and
distal translations of the tibial component, respectively (studies I, II, and
III), while in study IV subsidence was defined as any type of movement
resulting in prosthetic motion into the bone and lift-off as translation away
from the bone.
The largest value of a standardized point for subsidence and lift-off was
chosen as maximum subsidence and maximum lift-off. MTPM (Maximal
Total Point Migration) is the vectorial length of the three-dimensional
translations of the point that moved the most (Ryd 1986). Movements of the
PE liner in relation to the metal baseplate can occur also in fixed bearing
modular components (Nilsson et al. 2003, Hansson et al. 2005). These
movements occur most entirely as rotations in the horizontal plane (ie,
internal-external rotation) equivalent to anterior-posterior (AP) and medial-
38
lateral translation. When using modular components with markers only in the
PE (study I), it is impossible to determine how much of such recorded
movements are occuring between the PE and the baseplate, and between the
baseplate and the bone, respectively. Therefore, MTPM was not used in
study I. In studies II, III and IV, however, the MTPM measurement were
based on the markers inserted on the tibial tray, the femoral component, or
in the polyethylene of the monoblock trabecular metal tibia, and could
therefore be relied on. MTPM has been used for prediction of future risk for
loosening by Ryd et al. (1995). The change of MTPM between 12 and 24
months should not exceed 0.2 mm for a component to be classified as stable,
otherwise it is classified as continuously migrating.
The precision of the RSA measurements was determined with double
examinations of all patients at each follow-up interval according to Ranstam
et al. (2000). Significant values at a 95% level of significance are illustrated in
table 3.
Table 3. Precision of RSA measurements
Study I II III IV
Transverse axis (degrees) 0.18 0.17 0.25 0.37
Longitudinal axis (degrees) 0.20 0.21 0.26 0.25
Sagittal axis (degrees) 0.18 0.19 0.17 0.20
Subsidence and 0.10 0.10 0.11 0.15

lift-off (mm)
Histology
One trabecular metal tibial component was retrieved at revision (paper III).
The tibial tray was cut through the pegs with a few mm of proximal tibial
bone and the pegs then were trephined out with 1-2 mm surrounding bone
39
tissue. The implant-bone specimens were fixed en bloc in formaldehyde,
processed, and embedded in methylmethacrylate undecalcified. On an
EXAKT® saw-cutting machine 4 serial coronal sections were made through
the tibial implant at about 100 microns. The pegs were treated identically and
grounded to a thickness of less than 50 microns. Surface staining with blue-
basic fuchsin was used.
Statistics
The statistical methods used are described and accounted for in the
respective papers.
40
RESULTS
Summary of papers I – IV
Paper I
Uncemented HA-coated Implant is the Optimum Fixation for

TKA in the Young Patient.
Patients and preoperative data
Eighty-five patients (97 knees) with osteoarthritis or inflammatory arthritis

were operated with TKA. They were randomized into three groups having
different types of fixation of the tibial component. Cemented, uncemented
(HA coated) with screws, or uncemented (HA coated) without screws.
Preoperative demographic or clinical data did not differ between the
groups with one exception; the uncemented groups had larger preoperative
varus malalignment (Kruskal-Wallis test, p < 0.05). The patients were
followed for two years with clinical scores (Knee Society Knee Scoring
System and Hospital for Special Surgery Score) and RSA examinations.
RSA results
At 3 months postoperatively, the migration of the cemented implants was

less than the migration of the uncemented implants (Kruskal-Wallis test).
Post hoc analysis with Mann Whitney U test revealed no differences between
the two uncemented groups . At 24 months, there were no differences in the
magnitude of migration either in AP rotation, varus-valgus rotation, maximal
41
subsidence or maximal lift-off between the groups. The pattern of migration
differed between the cemented implants and the uncemented implants. The
cemented implants migrated continuously until the 2-year followup. The
uncemented groups, on the other hand, had all their migration during the
initial 3 months and stabilized thereafter. There were no statistically
differences in pattern or magnitude of migration between the two
uncemented groups. Maximum lift-off increased in all three groups up to the
2-year examination.
Clinical and radiographic results
The clinical results improved during the follow-up with no differences

between the groups (Kruskal-Wallis test). Radiolucents lines were not seen in
any implant postoperatively. In the cemented group about 25 % of the
implants developed thin (< 1 mm) radiolucent lines at the most medial or
lateral centimeter of the tibial tray. In no case were these lines progressive. In
the uncemented groups were no radiolucent lines seen with one exception.
This knee (HA coated, no screws) displayed a large tilting of the implant up
to 6 weeks and developed a radiolucent line with 1 to 2 mm thickness.
However, after 6 weeks this implant stabilized up to 2 years and the
radiolucent line disappeared gradually. No osteolytic lesions around the
screws or under the trays were seen in any knee of the three groups.
Conclusion
The cemented implants displayed less migration the initial three months than
the uncemented implants, but at 2 years there were no difference. The
cemented implants migrated continuously during the entire follow-up period.
The uncemented groups displayed all their migration the first 3 months,
except of implant lift-off, which was contiuously increasing up to 2 years.
42
There were no differences in magnitude or pattern of migration between the
two uncemented groups indicating that screws do not improve fixation.
Uncemented fixation with hydroxy-apatite coated implants without screws
seems to be a good solution for young patients, though the finding of
implant lift-off is concerning.
Paper II
Mobile Bearings Do Not Improve Fixation in Cemented

Total Knee Arthroplasty.
Forty-seven patients (52 knees) with primary osteoarthritis were randomized

to receive either or NexGen Option CR fixed bearing total knee arthroplasty
or a MBK mobile bearing total knee arthroplasty. The patients were followed
with RSA examinations and clinically using the Knee Society Scoring System
for two years.
RSA results
The magnitude of migration did not differ between the implants during the
follow-up. The mean and median values were small with a few outliers in
both groups. The direction of the rotations was evenly distributed between
rotations around the X-axis, Y-axis, and Z-axis. The pattern of migration
differed between the groups in vertical translation of the tibial tray. These
tilting movements implied a median lift-off of the medial and central parts of
the NexGen implants, whereas the MBK implant displayed subsidence into
43
tibia at these locations. The maximum subsidence from 3-24 months was
significantly larger for the MBK implant (p=0.05, repeated measures
ANOVA), and maximum lift-off was significantly larger for the NexGen
implants (p=0.02, repeated measures ANOVA).
The number of unstable implants according to Ryd et al. (1995) were 6 in the
MBK group and 3 in the NexGen group (ns).
The Knee Society scores increased during followup. There were no

differences in clinical results between the groups (Mann-Whitney U test). In
seven knees in each group thin radiolucent lines developed under the most
medial, lateral and posterior part of the implant. In no case was there
progression in thickness of the radiolucent lines and no lines were seen at or
around the entire stems. The magnitude of migration was not greater in
implants with thin radiolucent lines compared with the ones without such
lines. The tibial component alignment did not differ between the groups in
either the frontal or the sagittal plane.
Conclusion
The hyptothesis that mobile bearing implants would result in improved

fixation of the tibial component could not be confirmed. The mobile bearing
implants did not perform better than the fixed bearing implants in any
aspect. It might be that the somewhat stiffer Co-Cr baseplate used in the
MBK knees and the different design of the articular surface in some
unknown way counteracts any potential positive effect of the mobile bearing.
44
Paper III
Trabecular metal tibial component in total knee arthroplasty

in patients younger than 60 years. A prospective RSA study.
Forty-one patients (47 knees) aged 60 years or younger with osteoarthritis

were operated with either a cemented NexGen Option CR modular TKA or
an uncemented monoblock trabecular metal tibia (TM CR). Due to
imperfections of the randomization process, the operations were performed
consecutively by the same surgeon (AH). The patients were followed by
RSA examinations and radiological evaluation for 2 years. Clinical follow-up
were done according to the Knee Society Scoring System.
RSA results
The TM CR implants displayed larger magnitudes of migration in AP

rotation, varus-valgus rotation and internal-external rotation than the
cemented implants at 3 and 24 months (Mann Whitney U test). The TM CR
implants also subsided more than the cemented implants, but there were no
differences of implant lift-off. However, the values for maximal lift-off in the
TM CR group were below the precision of the RSA method, whereas the
values in the cemented group were equal to or larger than the precision. In
about 25 % of the TM implants there were subsidence of one part of the
implant and lift-off of the contralateral part. Two implant in the TM CR
group and three in the cemented group were defined as unstable according to
Ryd et.al (1995). This difference was not statistically significant. Both groups
migrated up to 3 months and then they stabilized with one exception; the
45
stabilization in internal-external rotation for the TM CR implants occurred
first after 12 months.
Clinical and radiological results
The Knee Society knee score and pain score improved during follow-up. The
NG group displayed higher knee score at 12 and 24 months due to better
range of motion, but the pain score did not differ between the groups. The
HKA angle and the alignment of the tibial component in relation to tibia was
the same in both groups postoperatively. Radiolucent thin lines were seen in
about 50 % of the NG group and in one implant of the TM group at 24
months. None of these lines were progressive.
Conclusion
Both groups migrated up to 3 months and then stabilized, with the exception
of external rotation of the TM implants, which stabilized first at 12 months.
The majority of the TM implants displayed subsidence with no lift-off. This
pattern with no lift-off is regarded beneficial for uncemented fixation and
thus may be suited for younger patients.
46
Paper IV
Cemented versus uncemented fixation of the femoral

component of the NexGen CR total knee replacement
patients younger than 60 years. A randomized RSA study.
41 consecutive patients (47 knees) were randomized to received either a

cemented NexGen femoral component or a porous-coated uncemented
NexGen femoral component. The patients were 60 years or younger with
primary or secondary osteoarthritis. Preoperatively there were no differences
in age, Knee Society Score or knee alignment between the groups. Follow-up
with RSA, radiological and clinical evaluation was done up to 24 months
postoperatively.
RSA results
There were no differences in rotation around the three cardinal axes at 3, 12

or 24 months (Mann Whitney U test). Most of the rotation occurred up to
three months. Maximum subsidence and maximum lift-off did not differ
between the groups and in both groups took place mainly during the first
three months. No significant difference regarding MTPM was found and
four implants in each group were defined as continuously migrating.
The clinical results measured as the Knee Society knee score and pain score
improved over time. At 24 months, there were no differences between the
47
groups. The HKA angle did not differ between the groups. Two thirds of the
cemented implants and half of the uncemented implants developed thin
radiolucent lines during follow-up. In no case were these lines progressive.
Conclusion
Since no differences between cemented and uncemented porous coated

femoral component of the same design could be detected either in magnitude
or pattern of migration or in clinical scores, it seems that uncemented
fixation of the femoral component is equally as good as cemented fixation in
the young patient. Uncemented fixation could be an advantage in infection of
a TKA.
48
DISCUSSION
The results of total knee arthroplasty in younger patients are inferior
(Robertsson et al. 2001, Gill and Joshi 2001, Furnes et al. 2002, Harrysson et
al. 2004, Gioe et al. 2007) and the demand for total knee arthroplasty in this
group of patients is increasing (Robertsson et al. 2000, Laskin 2002, Ritter
2002). Loosening of components, especially on the tibial side is, besides
polyethylene wear, the major cause of failure both in older (Moreland 1988,
Knutson et al. 1994, Sharkey et al. 2002) and younger patients (Robertsson et
al. 2001, Harrysson et al. 2004). Younger patients have a higher level of
activity and a longer life expectancy that will put higher stresses and demands
on the implants. Total knee arthroplasty in the younger age group should
therefore have designs and modes of fixation that will last 25 years or longer.
Mobile bearing total knee arthroplasty was introduced as a mean to reduce

polyethylene wear and improve the kinematics and the fixation of the implant
to bone (Goodfellow and OĆonnor 1986, Buechel and Pappas 1986).
Theoretically, this design would uncouple the forces acting on the interface
and hence lower the risk of tibial component loosening. The kinematics of
the artificial knee improves in mobile bearing TKAs compared to fixed
bearing TKAs (D´Lima 2000, Dennis and Komistek 2006) and the stresses at
the implant-bone interface is reduced experimentally (Bottlang et al. 2006).
The contact stress is reduced ((Matsuda et al. 1998, Stukenberg-Colsman et
al. 2002, Sharma et al. 2007) and the polyethylene wear is less than that of
fixed bearing TKAs (Tsakonas and Polyzoides 1997).
No superiority of mobile bearing TKAs compared to fixed bearing TKAs
have been shown though good long-term results have been reported
(Buechel 2004, Callaghan et al. 2005, Tarkin et al. 2005). One study in
younger patients showed excellent result after 7 years (Morgan et al. 2007).
49
There are only two randomized studies in the literature concerning mobile
bearing TKA. Aglietti et al. (2005) found no clinical differences between
fixed or mobile bearing TKA in a short-term study. Using uncemented fixed
and mobile bearing TKAs Hansson et al. (2005) in a RSA study found no
differences in clinical results or migration between the two concepts.
In study II we used RSA to evaluate the migration of the NexGen Option
CR fixed bearing and the MBK mobile bearing arthroplasties with cemented
fixation. The patients in this study had a mean age of 72 years (62-84 years).
Since the potential benefits of mobile bearing TKA may be larger in younger
patients, ideally such patients should have been examined. However, the
incidence of osteoarthrosis treated with TKA is still, though slowly
increasing, low in Sweden and in order to recruite patients in a reasonable
time for the study to finish, we choose not to use younger patients. Since our
interest was to study the pattern of migration, any differences between the
two designs, using a high-resolution method such as RSA, would have been
identified even in older patients.
The magnitude of migration was similar in both groups. The number of
unstable implants according to Ryd et al. (1995) was twice as many in MBK
group (6/23) compared to the NG CR (3/26). This difference is, however,
not statistically significant. Hansson et al. (2005) found the same tendency
with 4 out of 19 unstable implants in the mobile bearing group compared to
one out of 18 in the fixed bearing group. This difference was not significant
either. Interestingly, the magnitude of internal-external rotation in our study
did not differ between the groups. A freely rotating PE-liner would
theoretically transmit less force to the implant-bone interface and thus induce
less rotation of the tibial implant in relation to bone. The ability of a mobile
PE-insert to rotate has been shown by Fantozzi et al. (2002) and Komistek et
al. (2004). The magnitude of rotational migration of the tibial tray in the
50
MBK knees in our study might suggest that the PE-liners did not have the
capacity to rotate on the tibial tray or that the forces between the liner and
the tray during weight-bearing prevented rotation and thus increased the
forces at the implant-bone interface, as proposed by Otto et al. (2001).
The pattern of migration in vertical translation differed between the fixed
and the mobile bearing groups. Both types of implants showed tilting
movements with subsidence of some part of the tray and lift-off of the other.
The MBK tibial trays subsided more, whereas the NG CR trays displayed
more lift-off. There is no obvious reason for this finding. It might be that the
stiffer Co-Cr tibial tray or the higher conformity of the mobile bearing
prosthesis counteracts the potential effects of the mobile bearing.
Cemented joint arthroplasties have some potential disadvantages. Sign of

osteolytic activity have been found at the cement-bone interface even in
clinically stable implants (Linder and Carlsson 1986, Fornasier et a. 1991,
Schmalzreid et al. 1992, Bos et al. 1995). Macrophages and wear particles of
cement and PE are found at the interface. Activation of macrophages from
wear particles can induce bone resorption (Schmalzreid et al. 1992, Bos et al.
1995). Numerous RSA studies have revealed a typical pattern of migration of
cemented TKAs (Nilsson et al. 1991, Nilsson and Kärrholm 1993, Önsten et
al. 1998, Nilsson et al. 1999, Carlsson et al. 2005). The initial migration is
small, mainly because the cement act as a filler that can accommodate for the
imperfections of the exposed tibial surface. The cemented implants then
continue to migrate over time, a process that does not stop after 2 years but
continues further on (Nilsson et al. 1999, Carlsson et al. 2005), even up until
10 years (Nilsson and Dalén 2008). This pattern of migration could be
interpreted as a sign of continuous bone resorption at the interface (Linder
1994), a process that may not be of any importance in the group of older
51
patients receiving knee replacements, but might interfere with long-term
fixation in younger patients.
The cemented tibial implants in younger patients in study I displayed this
typical pattern of migration and, though not stated in paper II, so did the
NG implants in study II. In contrast to these and earlier findings of
cemented tibial components, the NG implants in study III displayed a
different pattern of migration. The NG implants migrated initially, but
stabilized after 6 weeks. Furthermore, the magnitude of migration was
smaller than previously found for cemented tibial implants. There is no
obvious explanation for this pattern. Bertin et al. (2002) showed that the
kinematics of the NG CR prosthesis were more close to the kinematics of
the normal knee than other TKAs studied, and maybe this could lead to less
stresses of the interface. The NG CR prosthesis has a peripheral lip at the
undersurface, that, as suggested by Vertullo and Davey (2001), increases the
cement penetration on impaction. Clinical reports of cemented NG CR are
in favour with this pattern of migration. Bertin (2007) found no prosthetic
failure of the NG CR arthroplasty in a mid-term follow-up and this design is
also the best performing prosthesis in SKAR (Lidgren et al. 2007). It might
be that the NexGen CR prosthesis have a more favourable design than other
cruciate retaining TKAs. Nevertheless, the NG implants in study II
displayed the typical pattern of continuous migration of cemented implants.
Maybe the stronger bone in the younger patients in study III could
withstand the forces acting on the implant-bone interface better and thus
reduce the magnitude of migration to values below the precision of the RSA
method. Longer follow-up of these implants will be needed to evaluate this.
A constant finding in both the cemented Profix prosthesis in study I, the
MBK and the NG CR prostheses in study II and the NG CR prosthesis in
study III is implant lift-off. This is a concern since lift-off has a potential of
52
exposing the interface and thus a possibility of entrance of joint fluid
containing wear particles, which, if activating macrophages could lead to
bone resorption and in the end a higher risk for implant loosening. Lift-off is
a common finding in metal-backed tibial components (Nilsson and Kärrholm
1991, Nilsson et al. 1999). The stiffness of the metal tray might be an
explanation for this behaviour.
Coating uncemented implants with hydroxy-apatite (HA) has proven to
enhance the fixation to bone (Bellemans 1999, Søballe et al. 1999). Several
RSA studies of HA-coated tibial components have shown improved fixation
compared to cemented or uncemented components without HA coating
(Nelissen et al. 1998, Nilsson et al. 1999, Toksvig-Larsen et al. 2000, Regnér
et al. 2000, Carlsson et al. 2005, Nilsson and Dalén 2008). Fixation of tibial
baseplates with screws was shown to enhance the initial stability of the
implants (Voltz et al. 1988, Lee et al. 1991). Osteolytic lesions were, however,
seen frequently (Peters et al. 1992, Lewis et al. 1995, Berger et al. 2001b,
Goldberg and Kraay 2004). To my knowledge there are no randomized
studies of HA-coated tibial components in younger patients and no studies
of screw-inforced tibial components in younger patients either.
In study I we choose to recruite patients younger than 65 years old in order
to finish the study in a reasonable time. However, only 18 of 97 knees (18
%) were in patients older than 60 years, equally distributed in the different
groups. The tantalum markers were spread into the PE liner. Movements of
the PE liner in relation to the tibial base plate can occur (Nilsson et al. 2003,
Hansson et al. 2005). These movements occur most entirely as rotations in
the horizontal plane equivalent to AP and medial-lateral translation. To
determine if some amount of the recorded movements are between the PE
liner and the base plate or between the base plate and the bone, respectively,
is impossible if there are not markers in the tibial tray as well (which was not
53
the case in study I). Therefore the rotations of the tibial component were
only measured around the transverse and sagittal axis, and the translations
only along the vertical axis (subsidence and lift-off).
The uncemented implants displayed most of their migration the first 3
months and then stabilized, in contrast to the cemented implants that
migrated continuously. The initial migration of the HA-coated groups was
greater than that of the cemented implants. This is explained by the
imperfections of the cut surface of the proximal tibia. After cutting, the
surface has irregularities with 1.0 to 2.4 mm difference between the highest
and lowest points (Toksvig-Larsen et al. 1991).The uncemented implant,
therefore, subsides until it settles on sufficiently wide and strong bone that
resists the forces acting on it. The migration stops when the implant has
settled, indicating a biologically mature interface. Since HA is
osteoconductive, a prerequisite for bony ingrowth or ongrowth are present.
Moreover, HA has a potential to seal gaps between implants and bone
(Rahbek et al. 2000). In the patient in whom the implant tilted during the first
week and also developed a radiolucent line under the entire lateral part of the
implant, the implant stabilized at 6 weeks and the radiolucent line
disappeared gradually presumably as a result of the osteoconductive
properties of HA. There was one exception from the stabilization of the HA-
coated implants between 3 and 24 months, implant lift-off increased in the
same way as the cemented groups up to 2 years. This is a concern, since lift-
off might have he potential to expose the interface to joint fluid. However, it
might be that the sealing property of HA (Søballe et al. 1999, Rahbek et al.
2000) is sufficient to counteract the effect of lift-off in HA-coated implants
as compared to the cemented implants. Longer follow-up will be needed to
evaluate this. There were no differences in the magnitude or the pattern of
migration between the uncemented HA-coated groups with or without
54
screws indicating that screws do not improve fixation of tibial implants to
bone.
Trabecular metal have several theoretical advantages with properties similar

to bone (Bobyn et al. 1999a). A high friction coefficient (Zhang et al. 1999)
may enhance initial stability and a low stiffness (Florio et al. 2004) may
transfer less load to the interface, as shown by Adalberth et al. (2000) in all-
polyethylene components. The trabecular metal tibial components in study
III displayed a similar pattern of migration as other uncemented tibial
components, i.e. a greater initial migration followed by stabilization.
However, some exceptions from this pattern were seen. The tibial
components stabilized at 3 months except in internal-external rotation that
did not stabilize until 12 months. The reason for this might be that the design
with only 2 pegs may not be enough to resist the externally rotating forces
acting on the implant. Rotation about the transverse axis, which is in line
with the 2 pegs, was also larger than about the sagittal axis. Three or four
pegs would theoretically resist those rotational forces better.
Initial stability is crucial for bony ingrowth or ongrowth. Toksvig-Larsen et
al. (1998) found inducible displacement of tibial components at 6 weeks
postoperatively, but speculated that this may be due to elastic micromotion
within the cancellous bone and thus not preclude bony ingrowth. According
to Bellemans (1999) will fibrous integration of the tibial implant lead to
increased migration not becoming apparent until after 1 year. The complete
stabilization of the TM implants at 12 months in our study might, therefore,
indicate a possibility for bony ingrowth or ongrowth. Another exception
from the typical pattern of migration was that the majority of the trabecular
tibial implants subsided with the entire implant into tibia. This is an
important finding because of the absence of lift-off. The reason for this
55
behaviour might be the low stiffness of trabecular metal as suggested by
Florio et al. (2004). The subsidence was 0.8 mm at 6 and 3 months and is
presumingbly the reason for the disappearance of all but one of the nine thin
radiolucent lines found postoperatively. Moreover, gap healing properties of
trabecular metal have been shown by Bragdon et al. (2004) and Rahbek et al.
(2005). Lift-off was seen in about 25 % of the trabecular tibial implants,
mostly occurring up to 6 weeks. Subsidence was less in these implants than in
those that showed subsidence of the entire implant. Possible explanation for
this may be that the tibial bone in these patients was stronger and tilting of
the implant with small subsidence of one part resulted in lift-off of the
opposite part despite the less stiff component. Longer follow-up will be
needed to evaluate the outcome and the consequences of these lift-offs.
One retrieved component showed no bony attachment at the base plate at
histiological examination. Instead, it was covered by a dense layer of fibrous
tissue growing into the porous coating. Hacking et al. (2000) demonstrated
complete ingrowth of fibrous tissue with high attachment strength into
porous tantalum. Close bone apposition was seen in the pegs with ingrowth
to a depth of 1 to 2 pores. Animal studies (Bobyn et al. 1999a, Bobyn et al.
1999b) have shown sufficient bony ingrowth into trabecular metal, but no
reports of ingrowth regarding implants in humans have been published. The
distinction between ingrowth and ongrowth is unclear. In order to establish a
sufficient interlocking between bone and implant one might expect at least
formation of bone past a trabeculum of the porous coating. It is, however,
not clear wether the knee with the retrieved component was infected or not.
The prescence of an infection would probably disturb any possible bony
ingrowth. The dense, well-organized fibrous tissue would, however, unlikely
be formed in face of an ongoing infection. Furthermore, it might be that
56
bony ingrowth in human tissue takes considerably longer time than in
animals.
Aseptic loosening of the femoral component is a lesser problem than that of

the tibial component (King and Scott 1985, Keating et al. 2002). Some
authors, however, report substantial problems with a high revision rate
(Mulhall et al. 2006) or a high frequency of osteolysis (Goldberg and Kraay
2004). Excellent results with no femoral loosenings in long-term studies of
both cemented (Schai et al. 1998, Berger et al. 2001a) and uncemented
(Schröder et al. 2001, Berger et al. 2001b, Whiteside 2001) TKAs have been
reported.
The optimum mode of fixation of the femoral component is still not
determined. Two RSA studies have evaluated the femoral fixation. Nilsson et
al. (1995) found no difference in migration between uncemented and
cemented implants. Using HA coating of the femoral component
Uvehammer et al. (2007) could not find any difference either. In study IV a
comparison between porous coated uncemented and cemented femoral
components were made in younger patients. No difference either in
magnitude or pattern of migration, in clinical or radiographic results were
found. The uncemented components displayed the same pattern as the
uncemented tibial implants in studies I and III with a large initial migration
followed by stabilization at 3 months. However, the cemented femoral
components displayed a similar pattern, in contrast to the cemented tibial
implants in studies I and II, which showed the typical pattern of cemented
tibial components with a small migration initially and a continuous migration
over time. One reason for this difference between femur and tibia might be
the anatomical differences, with femur having fixation surfaces in three
directions.
57
In younger patients, it does not seem to matter which mode of fixation to
choose. Tai and Cross (2006), in a long-term study of patients younger than
55 years, found no femoral loosenings of HA coated components.
Uvehammer at el. (2007) could, however, not find that HA coated femoral
components performed better than cemented femoral components. Apart
from shortening the operation time, uncemented components can to a higher
extent than cemented components be kept in situ in cases of deep infection
according to Dixon et al. (2004). The reason for this may be the abscence of
a partial necrotic interface in contrast to cemented components.
The typical pattern of migration of cemented implants with continuous

migration over time may not be of any clinical importance in elderly patients.
In younger patients, however, with their higher level of activity and longer
life expectancy, cemented implants may not be the best alternative. Coating
uncemented tibial implants with hydroxy-apatite have been shown to
enhance fixation to bone and the pattern of migration of those implants with
early stabilization could indicate a better long-term prognosis of fixation in
younger patients. Trabecular metal tibial implants subside into the tibia and
stabilize completely at one year, a pattern that indicates a good long-term
prognosis in younger patients. Since both hydroxy-apatite coating and
trabecular metal seem to have osteoconductive properties it would be
interesting to evaluate hydroxy-apatite coating of the trabecular metal
implants. It does not seem to matter which mode of fixation of the femoral
component to choose in younger patients.
58
CONCLUSIONS
- A hydroxy-apatite coated modern total knee prosthesis migrated more

than a cemented total knee prosthesis of the same design initially, but
stabilized at 3 months. Screw fixation of a hydroxy-apatite coated tibial
implant displayed the same pattern and magnitude of migration as a
hydroxy-apatite coated tibial implant without screws. This indicates a
good long-term prognosis of fixation of hydroxy-apatite coated
implants in younger patients and furthermore that screw fixation do
not enhance fixation to bone.
- A mobile bearing cemented total knee prosthesis displayed the same

magnitude and pattern of migration as a fixed bearing cemented total
knee prosthesis. The theoretical advantages of fixation to bone of
mobile bearing prostheses could not be confirmed.
- The majority of the trabecular tibial implants subsided into the tibia
without any lift-off. Complete stabilization of the trabecular tibial
implants occurred at 12 months. This indicates a good long-term
prognosis of fixation of trabecular metal implants in younger patients.
- The quality of fixation of cemented or uncemented femoral

components in younger patients did not differ. It is at the surgeon’s
discretion to choose the mode of fixation of the femoral component in
younger patients.
59
ACKNOWLEDGEMENTS
My sincere gratitude to:
Professor Kjell G Nilsson, tutor and friend. Your brilliance and never-
ending competence have been crucial for this work. Your hospitality and our
sunday morning discussions at your kitchen table have been invaluable.
Professor Olle Svensson, head of the department of Orthopedics in Umeå,

for provision of research fascilities, general support and a great deal of
lobbying.
Leif Hernefalk, MD,PhD, my former chief, for initiating the work and for
giving me time and pay necessary for the whole thing to happen.
Hanne Hedin, MD, PhD, my current chief, for continous support.
My co-authors, Tore Dalén, Lars Linder, Bo Norgren, Feng Gao.
Liselott Englund, Anna-Lena Lindén, Anna-Lena Johansson for very

accurate and useful RSA examinations.
Barbro Appelblad for measuring all the numerous RSA pictures.
Lisbeth Lindberg for cutting and preparing the beautiful histological
specimens.
The whole staff of the department of Orthopedics in Falun for letting me be

abscent from time to time.
Joakim Rang, head of Zimmer Sweden AB, for incomparable support.
Center for Clinical Research Dalarna (CKF) for giving me a room,

stimulating environment and financial possibility. Maria Pilawa for
enthusiastic help with everything and anything , Marianne Omne-Pontén,
Staffan Nilsson, without you this would not have happened. All fellow
researchers for friendliness, stimulating discussions and laughters.
At last, my precious wife Kia, for love, support and understanding and our
children Marie, Per, Magnus, Andreas, Erik for just being you.
60
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Total Knee Arthroplasty: Aspects On Improved Fixation in The Younger Patient

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Umeå University Medical Dissertations

New Series no 1172 – ISSN 0346-6612

Total knee arthroplasty

Printed by Print & Media, Umeå University, Umeå 2008

BMI Body Mass Index

Treatment of osteoarthrosis of the knee with total knee arthroplasty is an

It seems as if patients younger than 55 to 60 years have higher revision rates

OA (osteoarthrosis) or RA (rheumatoid arthritis). The incidence of total knee

The tibial component

In general, it seems that uncemented concepts are afflicted with problems

The femoral component

The optimum mode of fixation of the femoral component seems unclear.

A successful total knee arthroplasty should fulfil three important criteria;

Radiostereometric analysis (RSA)

- to evaluate the magnitude and pattern of migration of a mobile

- to compare the migration pattern and magnitude of an uncemented

- to evaluate the migration pattern of uncemented trabecular metal tibial

- to compare the quality of fixation of cemented versus uncemented

Patients with incomplete follow-up

Table 1. KNEES with incomplete follow-up due to RSA imperfections.

Poor RSA radiographs or too few markers visible

The NexGen Option CR (NG CR) prosthesis (Zimmer, Warsaw, IN,

The MBK prosthesis (Zimmer, Warsaw, IN, USA) (Figure 3) is a mobile

Figure 2. The porous femoral component of the NexGen

Figure 3. The MBK prosthesis

Figure 4. The trabecular metal tibia.

Patellar components. In study I the patellar component was of the inset

All patients were followed for 24 months with preoperative and

The randomization process in studies I, II and IV was carried out by

RSA (Radiostereometric analysis)

During the operations, 7- 9 tantalum spheres (diameter 1.0 mm) were

Table 2. Condition number and mean error of rigid body fitting

Mean error of rigid

The migrations of the implants were expressed as rotations around the

Table 3. Precision of RSA measurements

Transverse axis (degrees) 0.18 0.17 0.25 0.37

Longitudinal axis (degrees) 0.20 0.21 0.26 0.25

Sagittal axis (degrees) 0.18 0.19 0.17 0.20

Subsidence and 0.10 0.10 0.11 0.15

Uncemented HA-coated Implant is the Optimum Fixation for

Patients and preoperative data

Eighty-five patients (97 knees) with osteoarthritis or inflammatory arthritis

At 3 months postoperatively, the migration of the cemented implants was

Clinical and radiographic results

The clinical results improved during the follow-up with no differences

Mobile Bearings Do Not Improve Fixation in Cemented

Patients and preoperative data

Forty-seven patients (52 knees) with primary osteoarthritis were randomized

Clinical and radiographic results

The Knee Society scores increased during followup. There were no

The hyptothesis that mobile bearing implants would result in improved

Trabecular metal tibial component in total knee arthroplasty

Patients and preoperative data

Forty-one patients (47 knees) aged 60 years or younger with osteoarthritis

The TM CR implants displayed larger magnitudes of migration in AP

Clinical and radiological results

Cemented versus uncemented fixation of the femoral

Patients and preoperative data

41 consecutive patients (47 knees) were randomized to received either a

There were no differences in rotation around the three cardinal axes at 3, 12

Clinical and radiographic results

Since no differences between cemented and uncemented porous coated

Mobile bearing total knee arthroplasty was introduced as a mean to reduce