Knee Surgery, Sports Traumatology, Arthroscopy

https://doi.org/10.1007/s00167-020-05997-4

KNEE

No clinical difference between TiN‑coated versus uncoated cementless

CoCrMo mobile‑bearing total knee arthroplasty; 10‑year follow‑up
of a randomized controlled trial
Jan K. G. Louwerens1 · Niels Hockers1 · Gijs Achten1 · Inger N. Sierevelt1 · Peter A. Nolte1 · Ruud P. van Hove2

Received: 22 January 2020 / Accepted: 10 April 2020

© European Society of Sports Traumatology, Knee Surgery, Arthroscopy (ESSKA) 2020

Abstract
Purpose  Improvement of biomechanical properties of cobalt–chromium–molybdenum (CoCrMo) implant surface and reduc-
tion of adhesive wear is achieved by titanium–nitride (TiN) coating in vitro. Less pain, higher postoperative outcome scores
and a lower revision rate after TKA with a TiN-coated CoCrMo TKA compared with uncoated CoCrMo TKA after 10-year
follow-up was hypothesized.
Methods  In a double-blinded RCT, 101 patients received a cementless mobile-bearing CoCrMo TKA, either TiN-coated
or uncoated. The primary outcome measure was the visual analogue scale (VAS) score for pain and secondary outcome
measures were the Knee Society Score (KSS), Oxford Knee Score (OKS), revision rate and adverse events. Patients were
assessed at 6 weeks, 6 months, 1 year, 5 years and 10 years, postoperatively.
Results  68 patients (67%) were available for 10-year follow-up. No difference was found in any of the assessed outcome
measures with a mean decrease in VAS score (31.6 ± 22.9) and a mean increase in OKS (10.9 ± 8.4), KSS (29.3 ± 31.4),
KSSK (26.4 ± 18.2) and KSSF (4.1 ± 22.9). Overall revision rate was 7% (coated 6% vs uncoated 8%) without additional
revision procedures between 5 and 10-year follow-up.
Conclusions  The in vitro potential benefits of TiN coating did not result in better clinical outcome when compared to an
uncoated cementless TKA. Pain, functional outcome and revision rates were comparable after 10-year follow-up. TiN-coated
cementless TKA provides comparable good long-term results, similar to uncoated cementless CoCrMo TKA.
Level of evidence  Level 1, Therapeutic Study
Netherlands Trial Register NL2887/NTR3033.

Keywords  Titanium–nitride · Patient outcome assessment · Coating · Total knee replacement

Introduction

Total knee arthroplasty (TKA) is a well-established treat-

ment for symptomatic end-stage osteoarthritis of the knee
Jan K. G. Louwerens and Niels Hockers share the first co- that no longer responds to conservative treatment [12]. TKA
authorship. has a rather good clinical outcome with high survival rates,
however approximately 10% of patients have persisting pain
Electronic supplementary material  The online version of this
up to 5 years after surgery [4]. To improve outcome after
article (https​://doi.org/10.1007/s0016​7-020-05997​-4) contains
supplementary material, which is available to authorized users. TKA, changes were made to the surgical approach, design
of the prosthesis, instrumentation and computer navigation
* Jan K. G. Louwerens was used [1, 6, 7, 30]. None of these alterations resulted in
jlouwerens@spaarnegasthuis.nl
a better clinical outcome compared to conventional TKA.
1
Department of Orthopaedic Surgery, Spaarne Gasthuis Ceramic coatings, such as titanium–nitride (TiN), are
Hospital, Hoofddorp, The Netherlands used to increase hardness and to reduce wear and friction
2
Department of Orthopaedic Surgery, Jeroen Bosch Hospital, of the implant surface [16, 21]. Furthermore, coating of
‘s‑Hertogenbosch, The Netherlands the bone-implant surface of cementless femoral and tibial

13
Vol.:(0123456789)

components might enhance osseointegration of the implant
[15, 16].
Cementless fixation of components is thought to be bene-
ficial for preservation of bone stock, absence of cement wear
particles and the creation of a ‘biological’ fixation of com-
ponents to bone [2, 23]. A recent study has shown excellent
results of a low contact stress, mobile-bearing (MB) TKA
system with all cementless tibia components with survivor-
ship of 97.4% at 17-year follow-up [20].
TiN-coated cobalt–chromium–molybdenum (CoCrMo)
cementless MB TKA has been successfully used in the treat-
ment of osteoarthritis of the knee [5, 22]. A 5-year follow-up
randomized clinical trial comparing cementless MB TiN-
coated CoCrMo TKA with uncoated CoCrMo MB TKA
showed no difference in postoperative pain, revision rate,
range of motion, swelling and temperature of the knee [15].
In this cohort, TiN coating of CoCrMo MB TKA was not
found to be a confounder on the postoperative Oxford Knee
Score (OKS) up to 5 years follow-up [14].
Improvement of biomechanical properties of cobalt–chro-
mium–molybdenum (CoCrMo) implant surface and reduc-
tion of adhesive wear is achieved by titanium–nitride (TiN)
coating in vitro. Although no clinical difference in results
was seen at 5-year follow-up, TiN coating of CoCrMo
cementless TKA might influence the postoperative outcome
at 10-year follow-up.
It is hypothesized that treatment with a TiN-coated
CoCrMo cementless MB TKA results in less postoperative
pain, a higher OKS and KSS, a higher degree of flexion and
a lower revision rate 10 years after surgery.
Material and methods
Between July 2006 and June 2007, 101 patients with an
indication for TKA were enrolled for a double-blinded ran-
domized controlled clinical trial as reported earlier [13]. A
TiN-coated CoCrMo cementless MB rotating platform total
knee prosthesis ­(CCI®, currently available as ­ACS® Basic,
Implantcast Gmbh, Buxtehude, Germany) was implanted
in the intervention group; the control group received an
uncoated CoCrMo cementless MB rotating platform TKA
­(LCS® Complete, DePuy, Warsaw, IN, USA). Both implants
have a similar design with regard to the radius and trochlear
groove design. Inclusion criteria for patients were indication
for TKA, age of 40 years or older, and the ability to give
informed consent. Exclusion criteria were revision TKA,
persisting pain after previous contralateral TKA, and no
informed consent. This started as a double-blinded study in
which patients and the primary investigator were blinded to
treatment allocation up to 5 years after surgery. At this point,
blinding for the patients was lifted. After 10 years two inde-
pendent investigators (NH & JL), blinded for the treatment
13
Knee Surgery, Sports Traumatology, Arthroscopy
allocation, re-assessed all available patients. Patients were
assigned to either the intervention group or the control group
according to a computer randomized list. The study report-
ing was based on the Consolidated Standards of Reporting
Trials Principles.
After 10  years a total of 68 patients (67%), equally
divided between groups, were available for follow-up. A
concise study flowchart is shown in Fig. 1 and the extensive
version as Supplementary Figure 5. Between 5 and 10-year
follow-up six patients died of non-TKA related causes in the
control group and five patients in the intervention group.
Patients were seen in an outpatient setting preoperatively and
6 weeks, 6 months, 1 year, 5 years and 10 years after surgery.
All patients were contacted by telephone and were asked to
fill out a questionnaire, followed by a clinical evaluation.
The primary outcome measure was the visual analogue
scale (VAS) for pain. Secondary outcome measures were the
Knee Society Score (KSS) with sub score Knee (KSSK) and
Function (KSSF), Oxford Knee Score (OKS), knee flexion
and flexion contractures and a radiological assessment for
tibial radiolucent lines [10, 14, 17, 28]. Revision surgery
was defined as replacement of the polyethylene insert, the
tibial or the femoral component of the TKA. The surgical
technique is comprehensively described in a previous article
[13]. No patella component was used.
The radiographic analysis was performed by two phy-
sicians: one senior orthopedic surgeon (PN), and one
independent researcher with experience in this field. The
presence of tibial radiolucent lines was assessed on AP
and lateral short leg radiographs, using the scoring system
designed by Ewald [8]. The data was compared with the
clinical outcome and a descriptive analysis on these find-
ings was performed. The study was approved by the medi-
cal ethical committee of the VU University Medical Center
Amsterdam and the trial was registered with the Netherlands
Trial Registry (NL2887/NTR3033).
Statistical analysis
Statistical analysis was performed using SPSS 24.0 for Win-
dows (SPSS Inc., Chicago, Il, USA). Continuous data are
presented as means with standard deviations (SD) and cat-
egorical data as numbers with accompanying proportions.
Univariate analyses using independent samples t tests and
Chi-squared tests (or Fisher’s exact in case expected val-
ues < 5) were performed to examine differences in patient
demographics and functional scores between the two groups
at baseline. Multivariate linear regression analysis was per-
formed for clinical outcome at 10 years follow-up to adjust
for age, gender, BMI and baseline values and adjusted β
coefficients (with 95% CI) are presented to describe the dif-
ferences between the treatment groups. A p value < 0.05 was
considered statistically significant. A sample size calculation
Knee Surgery, Sports Traumatology, Arthroscopy

Fig. 1  Study flow diagram.

Number of patients assessed for Patients planned for TKA (n= 232)
eligibility, inclusion, randomi-
zation and allocation to either
the intervention, TiN group or Not meeting inclusion criteria (n= 52)
the control, CoCrMo group,
lost to follow-up and analysis.
TiN titanium nitride-coated
total knee prosthesis, CoCrMo Patients eligible (n= 180)
cobalt–chromium–molybdenum
total knee prosthesis, V1 visit
1 at 6 weeks, V5 visit after Declined to participate (n= 79)
10 years

Randomized (n= 101)

Allocated to TiN Group (n= 51) Allocated to CoCrMo Group (n= 50)

V1 (n= 51) V1 (n= 50)

V5 (n= 34) V5 (n= 34)

Unwilling to attend (n= 2) Unwilling to attend (n= 5)
Unable to attend (n= 5) Unable to attend (n= 4)
Deceased (n= 5) Deceased (n= 6)
Untraceable (n= 3) Untraceable (n= 1)

was performed for the initial study with 5 years follow-up
[13]. Based on a 10-mm reduction of pain, a standard devia-
tion of 20 mm, with 90% statistical power and α level 0.05,
with the intention to treat and a response rate of 94%, the
estimated sample size was 50 patients for each group.
Results
Baseline characteristics are shown in Supplementary Table
A. The BMI was higher in the intervention group than the
control group (p = 0.01). No difference in other baseline
characteristics was detected. Clinical outcome measures
at baseline are shown in Table 1. Baseline VAS score,
KSS, KSSK, KSSF and OKS did not significantly differ
between groups. Clinical outcome measures at 10 years
follow-up are also shown in Table 1. The change in out-
come measures over time is shown in Figs. 2, 3 and 4.
A mean decrease in VAS score (31.6 ± 22.9) and a mean
increase in OKS (10.9 ± 8.4), KSS (29.3 ± 31.4), KSSK
(26.4 ± 18.2) and KSSF (4.1 ± 22.9) was found without
in-between group differences (Table 2). The knee flexion
after 10 years did not significantly change compared to
baseline. The percentage of patient with a knee flexion
contracture significantly declined. Before 5 years follow-
up two tibial component revisions in each group were per-
formed for loosening of the component. One layer spinout
was seen in a TiN-coated prosthesis. One case of surgical
intervention for a deep infection and one patellar resurfac-
ing was performed before 5 years follow-up for separate
cases in the uncoated group. In the coated group 6% was
revised versus 8% in the uncoated group, thus bringing
the total to a revision rate of 7%. Upon removal no macro-
scopically visible abnormalities of the prosthesis compo-
nents were seen in either of the two groups. No additional
revision surgery procedures were performed between 5
and 10-year follow-up.
After 10-year follow-up five cases showed tibial radio-
lucent lines, three cases in the uncoated group versus two
cases in the coated TKA’s. Radiolucent lines were equally
divided between the two implants as was the clinical out-
come. Table 3 reports details on the radiological assess-
ment as well as the clinical outcome of these five cases.

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 Knee Surgery, Sports Traumatology, Arthroscopy

Table 1  Clinical outcome measures at baseline and 10-year follow-up

Baseline 10-year follow-up
TiN (n = 51) CoCrMo (n = 50) p value TiN (n = 34) CoCrMo (n = 34) Adjusted β coefficient (95% p value
CI)

VAS for pain, mean (SD) 49.7 (19.4) 51.0 (19.1) n.s 17.9 (14.5) 19.6 (15.9) 0.2 (− 7.2; 7.6) n.s
Knee Society Score, mean 120.3 (20.7) 117.2 (20.2) n.s 154.8 (30.7) 151.9 (31.6) − 0.6 (− 13.5; 12.4) n.s
(SD)
 Knee 58.1 (16.2) 55.1 (13.5) n.s 85.3 (8.8) 82.6 (13.1) 1.3 (− 4.4; 7.0) n.s
 Function 62.2 (14.4) 62.1 (14.1) n.s 69.5 (28.8) 69.3 (24.9) 0.8 (− 10.3; 11.8) n.s
Oxford Knee Score, mean 28.8 (7.0) 25.7 (6.5) n.s 39.0 (7.7) 39.0 (8.1) − 1.6 (− 6.5; 1.9) n.s
(SD)
Knee flexion, [degrees, 115.7 (11.0) 111.3 (14.7) n.s 114.3 (13.0) 117.8 (11.6) − 4.1 (− 9.8; 1.7) n.s
mean (SD)]
Knee flexion contracture, n (%)
 None 32 (62) 32 (64) n.s 31 (91) 28 (83) n.s
 < 5° 2 (4) 2 (4) n.s 3 (9) 6 (17) n.s
 5°–10° 12 (24) 10 (20) n.s – – –
 10°–15° 4 (8) 3 (6) n.s – – –
 15°–20° 1 (2) 3 (6) n.s – – –

TiN titanium–nitride-coated total knee prosthesis, CoCrMo cobalt–chromium–molybdenum total knee prosthesis, VAS visual analogue scale
(0–100)

Breugem et al. retrospectively reported their results of

Fig. 2  Change in outcome over time for the VAS pain score
Discussion
The most important finding of this study is that, after
10-year follow-up, treatment with both a TiN-coated and
an uncoated CoCrMo cementless TKA results in a good
functional outcome with acceptable revision rates. It also
provides important insight in the long-term performance
of TiN-coated TKA. The hypothesis that TiN-coated
CoCrMo cementless TKA results in less postoperative
pain, a higher OKS and KSS, a higher degree of flex-
ion and a lower revision rate 10 years after surgery, was
rejected. No clinical relevant differences were found for
any of the outcome measures 10 years after surgery.
more than a thousand TiN-coated cemented MB TKA’s,
using a design that is similar to the design used in this
study [5]. They reported VAS scores of 1 (in rest) and 2
(during activity) in the non-revision group 4 years after
surgery, comparable to the results in this study. With a
mean follow-up of 46 months, they reported a revision
percentage of 2.2%, all of which were early revisions per-
formed within 3 years of primary surgery. Although dif-
ferent functional outcome scores were used, comparable
satisfactory results were seen at final follow-up.
Recently Postler et al. reported their results of a 3 year
follow-up study, comparing TiN-coated versus uncoated
cemented fixed bearing TKA’s [25]. Again, no differences
in PROMS or knee function were found [25]. In addition,
their study also investigated metal ion concentrations
in blood samples for chromium, cobalt and nickel up to
1 year, postoperatively. They reported a significant lower
level of metal ions in blood samples in the coated TKA
group. Due to these findings a TiN-coated TKA could be
preferred although the clinical impact of higher metal ion
levels is unclear and needs further investigation.
At 5-year follow-up a difference in knee flexion was
found between the both groups. Multivariate analysis
showed that this was influenced by BMI and age at base-
line, but not influenced by type of implant used. After
10-year follow-up this difference was no longer visible,
similar to previous studies [3]. Increased knee skin tem-
perature and knee circumference were assessed at 5 year

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Knee Surgery, Sports Traumatology, Arthroscopy
Fig. 3  Change in outcome over time for the Knee Society Score. a
KSS total score b KSS knee score c KSS function score
Fig. 4  Change in outcome over time for the Oxford Knee Score
follow-up but not after 10 years since these parameters are
more relevant in the short term follow-up.
In the present study an early revision rate of 4% was
reported with a total revision rate of 7%. Between 5 and
10 years no additional revisions were performed. An overall
revision rate of 7% for cementless TKA is higher than the
revision rates reported for 10 years follow-up of cement-
less TKA in the National Joint Registries (NJR) of England/
Wales/Northern-Ireland/Isle of Man, Australia, and Sweden,
which are 4.2% [31], 5.2% [32] and 3.6% [33], respectively.
The NJR of Sweden did not discriminate between cemented
and cementless TKA. In this study, there was a relatively
high early revision rate for aseptic loosening. The indica-
tion for early revision of aseptic loosening after TKA was
primarily persisting pain after TKA. There are no proper
additional tests to confirm early aseptic loosening. It is also
known that after TKA a relatively high percentage has per-
sisting pain with numerous plausible causes [27]. Therefore
it is uncertain if these patients were revised for the right
reason, which subsequently resulted in a relatively high revi-
sion rate at 10-year follow-up.
Sadoghi et  al. reported a strong correlation between
knee pain and tibial radiolucent lines in a retrospective
study involving 553 patients with 566 TKA’s. Twenty-eight
patients with knee pain were matched against 28 control
patients without knee pain. Radiolucency was seen in 27
out of 28 cases with knee pain versus six out of 28 matched
controls without knee pain [29]. This study reports five cases
(5%) with tibial radiolucent lines, comparable to the study
by Sadoghi. Since the absolute number of patients was so
small, a descriptive analysis was chosen, which showed an
equal distribution between the two groups without an evi-
dent relationship to the clinical outcome.
Potential disadvantages of TiN coating of orthopedic
implants have been reported in the literature. Retrieval anal-
ysis of TiN-coated prosthetic femoral heads showed defects
in the coating [11, 19, 26]. Quality control of TiN-coated
implants was advised [19]. In a knee simulator test, TiN
coating of Ti6Al4V alloy showed minor to no signs of sur-
face delamination, surface scratching or coating failure [24].
In a retrieval analysis of 25 TiN coated femoral TKA compo-
nents with a mean implantation duration of 30.7 months and
infection and septic loosening as main reason for revision, it
was concluded that TiN coating shows a high level of wear
resistance to in vivo loading [9]. Also, the surface damage
of the TiN coating did not correlate to the time the implant
was in situ [9]. In another retrieval analysis of TiN coated
TKA, three cases involving a cemented tibial component, a
cementless femoral component and a cemented femoral and
tibial component were analysed [18]. The components were
revised after 15–18 months because of aseptic loosening and
periprosthetic infection. It was concluded that TiN coating
of TKA undergoes wear and degradation in vivo, especially
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 Knee Surgery, Sports Traumatology, Arthroscopy

Table 2  Improvement of Total (n = 68) TiN (n = 34) CoCrMo (n = 34) p value

clinical outcome scores at
10-year follow-up VAS for pain, mean (SD) 31.1 (22.9) 30.8 (19.5) 31.3 (26.2) n.s
Knee Society Score, mean (SD) 29.3 (31.5) 28.7 (35.3) 30.1 (27.8) n.s
Knee 26.4 (18.2) 26.1 (19.7) 26.7 (17.0) n.s
Function 4.1 (23.6) 4.8 (28.4) 3.4 (18.3) n.s
Oxford Knee Score, mean (SD) 10.9 (8.4) 9.3 (8.5) 12.5 (8.2) n.s

TiN titanium nitride-coated total knee prosthesis, CoCrMo cobalt–chromium-molybdenum total knee pros-
thesis, VAS visual analogue scale (0–100)

Table 3  Radiological Case TKA Tibial radiolucent lines. OKS KSSK KSSF VAS for pain
assessment Zone (view)

1 Uncoated 1 (lat) 13 84 100 11

2 Uncoated 1, 7 (AP) 25 87 70 50
3 Uncoated 3, 4 (AP)/3 (lat) 13 94 100 0
4 TiN coated 3, 4 (AP) 21 76 55 28
5 TiN coated 5, 6 (AP)/1, 2, 3 (lat) 22 84 70 27

AP anterior-posterior, lat lateral, KSS knee society score (knee/function), OKS oxford knee score, TiN tita-
nium nitride, VAS visual analogue score

in mobile bearing tibial trays [18]. One of the limitations of
this study, as mentioned by the authors is that only prema-
turely revised components were examined, which does not
represent a well-functioning TKA [18]. The revised implants
in these studies were of the same type and brand as was
used in this study. However, in our study solely cementless
components with mobile bearing tibial trays were used. This
might reduce the presence of third bodies and subsequent
third body wear. More retrieval analysis studies are needed
to be able to conclude on the use of TiN coating in TKA.
Until then, it would be premature to dismiss TiN-coated total
knee prosthesis as a good option for total knee arthroplasty.
Furthermore, the TiN-coated prosthesis used in this study is
30% less costly with an ODEP rating of 10B compared to the
uncoated prosthesis with an ODEP rating of 13A.
The strength of this study is that it provides long-term
prospective level-1 data on the performance of two fre-
quently used cementless total knee implants. Since the
debate over the use of cemented or cementless fixation in
total knee arthroplasty is still ongoing it is important to
report long-term follow-up cementless total knee arthro-
plasty data.
The results of this study must be interpreted in light
of several limitations. First, randomization did not result
in equal groups. Results were adjusted for these covari-
ates using GLM procedure for repeated measures. Second,
in comparison to the follow-up percentage after 5 years
(92%) the follow-up rate after 10 years (68%) declined
substantially. This can partly be explained by an aging
population, with subsequently an increase of morbidity
and mortality. The lost to follow-up was equally divided
between both groups. Information about potential addi-
tional revisions performed in other clinics was not avail-
able. All clinical files were analyzed for patients who were
not able to attend the 10 year follow-up, to make sure no
revisions were missed. As a result of the loss to follow-up,
this study might be underpowered to detect a difference
in reported outcome measures after 10 years. This is a
limitation future clinical trials should take into account.
Conclusion
The in vitro potential benefits of TiN coating did not result
in better clinical outcome when compared to an uncoated
cementless TKA. Pain, functional outcome and revision
rates were comparable after 10-year follow-up in this ran-
domized controlled trial. TiN-coated cementless TKA
provides comparable good long-term results, similar to
uncoated cementless CoCrMo TKA.
Funding  R. P. van Hove received funding from the Foundation of
Orthopedic Research, Spaarne Hospital Hoofddorp, The Netherlands.
Compliance with ethical standards 
Conflict of interest  The remaining authors declare that they have no
conflict of interest.

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Knee Surgery, Sports Traumatology, Arthroscopy

Ethical approval  All procedures performed in studies involving human 16. van Hove RP, Sierevelt IN, van Royen BJ, Nolte PA (2015) Tita-
participants were in accordance with the ethical standards of the insti- nium–nitride coating of orthopaedic implants: a review of the
tutional and/or national research committee and with the 1964 Helsinki literature. Biomed Res Int 2015:485975
Declaration and its later amendments or comparable ethical standards. 17. Insall JN, Dorr LD, Scott RD, Scott WN (1989) Rationale of
The study was approved by the Bioethics Committee of the VU Uni- The Knee Society clinical rating system. Clin Orthop Relat Res
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registered with the Netherlands National Trial Registry (NTR 3033). 18. Łapaj L, Rozwalka J (2020) Retrieval analysis of TiN (titanium
nitride) coated knee replacements: Coating wear and degradation
in vivo. J Biomed Mater Res B Appl Biomater 108:1251–1261
19. Łapaj L, Wendland J, Markuszewski J, Mróz A, Wiśniewski T
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