B. MAV^I^ et al.: INFECTION RISK ANALYSIS OF 101 SILVER-COATED ENDOPROSTHESES
449–453
INFECTION RISK ANALYSIS OF 101 SILVER-COATED
ENDOPROSTHESES
ANALIZA TVEGANJA ZA OKU@BO PRI 101 POSREBRENIH
ENDOPROTEZAH
Bla` Mav~i~
1,2*
, David Martin~i~
1
, Marko [piler
1
, Vane Antoli~
1,2
1
University Medical Centre Ljubljana, Department of Orthopedic Surgery, Zalo{ka cesta 9, 1000 Ljubljana, Slovenia
2
University of Ljubljana, Faculty of Medicine, Zalo{ka cesta 9, 1000 Ljubljana, Slovenia
Prejem rokopisa – received: 2019-05-06; sprejem za objavo – accepted for publication: 2019-05-23
doi:10.17222/mit.2019.094
Our aim was to analyse the implant survival and infection rates of 101 consecutive silver-coated MUTARS® (= Modular
Universal Tumour And Revision System) endoprostheses implanted at an independent orthopaedic tertiary hospital between
April 1, 2011 and December 31, 2018 and to compare them with previous outcomes of the MUTARS® developmental hospitals.
In addition, we tested the hypothesis that the infection-free survival rates of silver-coated implants depend on the patient’s age,
gender, pre-operative diagnoses and anatomical localization of the reconstruction. The cohort included 47 sarcoma resections,
29 revision arthroplasties, 20 metastatic resections, 3 benign bone tumours and 2 primary arthroplasties. Endoprosthesis was
located in the distal femur (38 patients), proximal femur (29 patients), proximal humerus (12 patients), proximal tibia (10
patients), pelvis (6 patients), total femur (5 patients) and distal humerus (1 patient). The mean age at implantation was 49 (range
11–86) years and the mean follow-up 3.2 (range 0.1–7.7) years. Twenty-four patients required at least one subsequent revision
operation and 15 endoprostheses had to be partially/totally removed. Patients’ age was an independent risk factor for
postoperative infection regardless of other confounding factors (hazard ratio 1.05 for each year; p = 0.02). With the overall
postoperative infection rate 12 % (4 % reinfection+8%newlyacquired) and cumulative partial/total implant removal rate 25 %
after 5 years, complications were comparable to the previous series of the MUTARS® developmental hospitals with high
variability between preoperative diagnoses and anatomical localizations. Silver-coated implants show a consistent trend of
preventing infections in high-risk body regions and enabling more successful treatment should infection occur, but 10–15 years
of clinical follow-up is required for further assessment.
Keywords: bone defect, modular endoprostheses, silver coating
Namen raziskave je bil analizirati pre`ivetje vsadkov in pogostnost oku`b v kohorti 101 zaporednih modularnih endoprotez
MUTARS® (= Modularni univerzalni tumorski in revizijski sistem) s posrebreno povr{ino, ki so bile vstavljene v neodvisni
terciarni ortopedski kliniki med 1. aprilom 2011 in 31. decembrom 2018, ter jih primerjati s predhodnimi rezultati razvojnih
bolni{nic vsadka MUTARS®. Poleg tega smo preverjali hipotezo, ali je pre`ivetje posrebrenih vsadkov brez oku`be odvisno od
starosti pacienta, spola, predoperativne diagnoze in anatomskega podro~ja rekonstrukcije. Skupina je obsegala 47 resekcij
sarkoma, 29 revizijskih artroplastik, 20 resekcij zasevkov, 3 benigne kostne tumorje in 2 primarni artroplastiki. Endoproteze so
bile vstavljene v distalno stegnenico (38 pacientov), proksimalno stegnenico (29 pacientov), proksimalno nadlahtnico (12
pacientov), proksimalno golenico (10 pacientov), medenico (6 pacientov), celotno stegnenico (5 pacientov) in distalno
nadlahtnico (1 pacient). Povpre~na starost ob vstavitvi endoproteze je zna{ala 49 (razpon 11–86) let, klini~no spremljanje pa 3,2
(razpon 0,1–7,7) let. [tiriindvajset pacientov je potrebovalo vsaj eno naknadno revizijsko operacijo in 15 endoprotez je bilo
treba delno/popolnoma odstraniti. Starost pacienta je bila neodvisen dejavnik tveganja za pooperativno oku`bo ne glede na
ostale pridru`ene spremenljivke (razmerje tveganja 1,05 za vsako leto starosti; p = 0,02). S skupnim dele`em oku`b 12 % (4 %
ponovna oku`ba+8%novopridobljena) in kumulativnim dele`em delnih/popolnih odstranitev endoprotez pri 25 % pacientov
v prvih 5 letih spremljanja je bila pogostnost zapletov primerljiva s predhodno objavljenimi raziskavami razvojnih bolni{nic
MUTARS®. Posrebreni vsadki v vseh raziskavah nakazujejo trend prepre~evaja oku`b in omogo~ajo bolj uspe{no zdravljenje,
~e do oku`be pride. Nadaljnje spremljanje v obdobju 10–15 let bo pokazalo, ali tak{ni srednjero~ni rezultati napovedujejo tudi
dobre dolgoro~ne izide.
Klju~ne besede: kostni defekt, modularne endoproteze, posrebrena povr{ina
1 INTRODUCTION
In the past two decades the trend of bone defect
reconstructions in limbs has shifted to the implantation
of massive, large modular endoprostheses
1,2
with an
inherent risk of periendoprosthetic infection, most likely
by styaphylococci.
3,4
Endoprosthetic infections have
been reported in up to 19 % of cases in proximal femur
replacements,
1,5
up to 11 % of cases in distal femur
replacements,
1,2
up to 23 % of cases in proximal tibia
replacements and up to 43 % of previously infected
endoprostheses.
4
Manufacturers have been trying to
reduce endoprosthetic infection rates with antimicrobial
implant surfaces like antibiotic-based, antiseptic, photo-
active-based or silver coatings.
6-8
Antibiotic coatings
have limited duration of drug elution and the risk of
resistance,
9
while effective antiseptic coatings (chlor-
hexidine, chloroxylenol) also exhibit toxicity.
2,10
The
nanostructured topography of the implants has also been
tested in vitro for anti-bacterial properties,
11-14
whereby
mesenchymal and embryonic stem cells were unable to
grow on surfaces with particular TiO
2
nanotube dimen-
Materiali in tehnologije / Materials and technology 53 (2019) 3, 449–453 449
UDK 620.1:615.461:005.52:005.334 ISSN 1580-2949
Original scientific article/Izvirni znanstveni ~lanek MTAEC9, 53(3)449(2019)
*Corresponding author e-mail:
blaz.mavcic@kclj.si

sions
14
. Metallic coating with silver has a low level of
human toxicity and longer-lasting antimicrobial silver
ion activity since the ions are only released into solution
from the implant surface at negative pH values.
15,16
The
antimicrobial efficacy of silver-coated endoprostheses
has not yet been confirmed in randomized controlled
studies, but several retrospective studies analysed
different implants,
17,18
among them the widely used
MUTARS® system (= Modular Universal Tumour And
Revision System, Implantcast GmbH).
1-4,6,19-24
These
studies were either conducted by the main developmental
hospital of this manufacturer (University Hospital Mün-
ster, Münster, Germany)
1,3,6,15,21,24
or in smaller centres
with patient series of 25–40 patients and<2y e a r s
follow-up.
4,5,20,22,23
So far no study has been published by
an independent institution with the entire cohort of a
hundred silver-coated MUTARS® implants and over 3
years of mean follow-up.
The aim of the presented study was to analyse the
infection rates and implant survival rates of the entire
cohort of 101 consecutive silver-coated MUTARS® mo-
dular endoprostheses implanted at an independent ortho-
paedic tertiary hospital with up to 7.7 years of follow-up
and to compare them with previously published out-
comes of the developmental hospital for this endopros-
thetic system. In addition, we tested the hypothesis that
the infection-free survival rates of silver-coated implants
depend on the patient’s age, gender, pre-operative diag-
noses and anatomical localization of the reconstructed
bone defect.
2 MATERIALS AND METHODS
A retrospective observational study of prospectively
collected data included an entire cohort of patients with
silver-coated MUTARS® endoprostheses implanted at a
single orthopaedic oncological tertiary hospital between
April 1, 2011 and December 31, 2018. Medical docu-
mentation was collected from the archives in order to
obtain the data on: pre-operative diagnosis, patient’s age
and gender at the time of surgery, localization of the
bone defect to be reconstructed, implanted MUTARS®
endoprosthesis type, all recorded complications during
implantation and in the course of the follow-up period,
possible revision operations, the need for partial/total
implant removal and infection-free implant survival until
December 31, 2018 or possible death before the end of
the observation period. None of the patients was ex-
cluded from the study or lost from the follow-up.
Statistical data analysis was performed with Office
Excel 2016 (Microsoft Corp, Redmond, WA) and IBM
SPSS Statistics 23.0 for Windows (IBM Corp, Armonk,
NY). Cumulative incidences of partial/total implant
removal for any reason were assessed after 1, 2 and 5
years of follow-up. The survival of silver-coated
MUTARS® implants until infection, until the first
revision or until partial/total implant removal was
assessed with the Cox regression models and covariables
of age, gender, preoperative diagnoses (sarcoma resec-
tion / metastasis resection / revision of previously un-
infected arthroplasty / revision of previous artificial joint
infection) and anatomical localization (proximal and
total femur / distal femur / proximal tibia / humerus /
pelvis). Statistical significance was set atP 0.05.
3 RESULTS
The study cohort included 101 consecutive silver-
coated MUTARS® endoprostheses with 47 cases of
primary sarcoma resection, 29 revision arthroplasties
after previous reconstruction (18 previous joint arthro-
plasties and 11 previous sarcoma resections), 20
metastatic resections, 3 aggressive benign bone tumours
and 2 complex primary total knee arthroplasties. The
endoprosthesis was located in the distal femur in 38
patients, proximal femur in 29 patients, proximal hume-
rus in 12 patients, proximal tibia in 10 patients, pelvis in
6 patients, total femur in 5 patients and distal humerus in
1 patient. The mean age at implantation was 49±20 years
(range 11–86 years) and the mean follow-up of patients
was 3.2 ± 2.2 years (range 0.1–7.7 years). We recorded 4
local tumour relapses and 20 patients died due to
oncological disease.
Twenty-four patients (24 %) required at least one
surgical revision of the silver-coated implant at a median
1.1 year after the initial implantation and 15 endo-
prostheses (15 %) had to be at least partially replaced or
entirely removed. Nine patients in the cohort had
previously been diagnosed/treated for artificial joint
infection before the silver-coated MUTARS® endo-
prosthesis was implanted and therefrom 4 infections
subsequently recurred; with an additional 8 cases of
newly acquired deep infections after the silver-coated
MUTARS® endoprosthesis implantation the total deep
infection rate was therefore 12 cases (12 %). In the
subgroup of newly acquired infections, 1 case was in the
proximal femur (3 % location-specific infection rate), 3
in the distal femur (8 % location-specific infection rate),
2 in the proximal tibia (20 % location-specific infection
rate) and 2 in pelvis (33 % location-specific infection
rate). Altogether, 6 silver-coated MUTARS® implants
had to be explanted eventually due to infection and 6
were retained with cured infection. Cumulative inci-
dences of at least partial replacement or entire implant
r e m o v a lf o ra n yr e a s o nw e r e4%a f t e r1y e a r( 1%
mechanical reasons/3%infection), 15 % after 2 years
(9 % mechanical reasons/5%infection/1%tumour
relapse) and 25 % after 5 or more years of follow-up
(13 % mechanical reasons/8%infection/3%tumour
relapse).
When the infection-free survival of silver-coated
MUTARS® implants was assessed with the Cox reg-
ression models and covariables of age, gender, preopera-
tive diagnoses and anatomical localization (Table 1), it
B. MAV^I^ et al.: INFECTION RISK ANALYSIS OF 101 SILVER-COATED ENDOPROSTHESES
450 Materiali in tehnologije / Materials and technology 53 (2019) 3, 449–453

turned out that a higher age at implantation was an
independent risk factor for implant infection, regardless
of all the other confounding factors (hazard ratio 1.05 for
each year; p = 0.02). There was also a trend of shorter
infection-free survival rates in patients with previously
diagnosed/treated infection (Figure 1) or pelvic resec-
tion (Figure 2), but the trend was not statistically
significant. On the other hand, age, gender, preoperative
diagnoses and anatomical localization had no statistically
significant impact on Cox regression implant survival
until the first revision or partial/total implant removal.
4 DISCUSSION
The limitations of the presented study include retros-
pective design, a high percentage of deceased patients
for oncological reasons and consequently a high number
of censored observations. Furthermore, the results in
revision arthroplasty patients are difficult to analyse
within or between different centres due to different
diagnostic methods of infection (e.g., sonication),
perioperative antibiotic regiments, number of previous
surgical procedures and pre-existing infections. All these
limitations were also present in all other recent studies of
this topic
1–6,19–24
where the infection-rate variability of
silver-coated implants was larger between different
patient populations (primary resection, metastases,
revision, previous infection) and anatomical localizations
than between different implant types (silver-coated vs.
non-coated).
2
However, within each selected patient
population and anatomical localization, silver-coated
implants have consistently shown lower infection rates in
comparison to other implants
18,25-26
and our results corro-
borate these findings in the setting of an independent
institution with longer follow-up from previous smaller
patient series.
4,5,20,22,23
The overall 12 % infection rate of
the presented study is almost identical to the previously
B. MAV^I^ et al.: INFECTION RISK ANALYSIS OF 101 SILVER-COATED ENDOPROSTHESES
Materiali in tehnologije / Materials and technology 53 (2019) 3, 449–453 451
Table 1: Cox regression model of infection-free survival in the entire cohort of 101 silver-coated MUTARS® implants with covariables of age,
gender, preoperative diagnose and anatomical localization (overall score Chi-square 24.2; p < 0.01). Statistically significant P-values & 0.05 are
marked with an asterisk (*).
B SE Exp(B) 95 % CI P-value
AGE [years] 0.05 0.02 1.05 1.01 1.10 0.02*
GENDER [female] –0.24 0.63 0.79 0.23 2.70 0.70
PREOPERATIVE DIAGNOSE
[ref] sarcoma resection
metastasis resection
revision without prior infection
revision after infection
–1.65
–0.55
–12.89
0.91
0.74
306.24
0.19
0.58
0.00
0.03
0.14
0.00
1.13
2.44
1.19
0.34
0.07
0.46
0.97
LOCALIZATION
[ref] prox./total femur
distal femur
proximal tibia
pelvis
humerus
–1.87
–0.30
–12.00
–0.55
1.30
0.95
304.23
0.99
0.15
0.74
0.00
0.58
0.01
0.12
0.00
0.08
1.95
4.76
5.63
3.99
0.65
0.15
0.76
0.97
0.58
B-regression line coefficient, SE-standard error, Exp(B)-hazard ratio, CI-confidence interval, [ref]-reference category
Figure 2: Cox regression model of infection-free survival in the
cohort of 101 silver-coated MUTARS® endoprostheses, stratified
according to the anatomical localization. Differences between strata
were not statistically significant.
Figure 1: Cox regression model of infection-free survival in the
cohort of 101 silver-coated MUTARS® endoprostheses, stratified
according to the pre-operative diagnosis. Differences between strata
were not statistically significant.

published series of mixed primary resections with
revision arthroplasty where Glehr et al.
27
reported an
infection rate of 12.5 % among 32 patients who had been
treated with MUTARS® silver-coated endoprostheses
and Wafa et al.
18
reported an overall postoperative infec-
tion rate of 11.8 % in the silver-coated group of 85
Agluna-Stanmore Implants. Likewise, Schmolders et al.
4
had to perform revision operations due to infection in
10 % of their implanted silver-coated MUTARS® endo-
prostheses after a median follow-up of 24 months for
primary or metastatic oncological patients. On the other
hand, infection rates for silver-coated implants in pri-
mary tumour resections (i.e., unrevised and uninfected
previously) of selected anatomical localizations (proxi-
mal and distal femur) were consistently lower: 3–8 % in
the presented study and 4–7 % in the studies of the main
MUTARS® developmental institution.
6
The presented study is the first one in the field of
silver-coated implants to demonstrate patients’age has as
an independent risk factor of infection. This finding is
not surprising as age-related higher complication rates
have already been identified in the treatment of uncoated
endoprosthetic infections,
28
the osteosynthesis of long
bones,
29
and spinal fusion.
30
Although the patients’ age
itself is a non-modifiable factor, additional precautionary
measures could be applied in elderly patients to reduce
the implant infection risk, e.g., different perioperative
antibiotic regimens, the use of local muscular flaps to
ensure sufficient soft-tissue coverage or earlier aggres-
sive drainage of haemathomas.
31
Not in the least, our
findings indicate that age should be one of the factors
when deciding upon the optimal radicality of the bone
tumour resection or the complexity of the bone defect
reconstruction in elderly patients.
5 CONCLUSIONS
This is the first study of a large MUTARS® silver-
coated endoprosthesis cohort performed by an inde-
pendent institution with up to 7.7 years of follow-up.
With the cumulative partial/total implant removal rate of
25 % after 5 years and postoperative infection in 12 % of
cohort patients, the complication rates were comparable
to the previously published series of developmental hos-
pitals with a high variability in results between different
preoperative diagnoses and anatomical localizations.
Patients’ age at implantation was identified as an inde-
pendent risk factor for subsequent infection, regardless
of all the other confounding factors.
Acknowledgment
This work was carried out at the Department of
Orthopaedic Surgery, University Medical Centre Ljub-
ljana, with no extra funding.
Ethics statement
The study protocol was reviewed and approved by
the National Medical Ethics Committee of the Republic
of Slovenia on September 19, 2017, case no.#
120-486/2017. All procedures performed in studies
involving human participants were in accordance with
the institutional/national ethical standards and with the
Helsinki declaration and its later amendments.
Conflict of interest
The authors declare they have no conflict of interest.
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