SYMPOSIUM: PERIPROSTHETIC JOINT INFECTION
Intraoperative Molds to Create an Articulating Spacer
for the Infected Knee Arthroplasty
Geoffrey S. Van Thiel MD, MBA, Keith R. Berend MD,
Gregg R. Klein MD, Alexander C. Gordon MD,
Adolph V. Lombardi MD, Craig J. Della Valle MD
Published online: 2 November 2010
? The Association of Bone and Joint Surgeons1 2010
ditionally treated with a two-stage protocol incorporating a
temporary antibiotic-loaded cement spacer. The use of a
static as opposed to an articulating spacer is controversial.
Some surgeons believe a static spacer results in a higher
rate of infection eradication, whereas others believe an
articulating spacer provides equivalent rates of infection
control with improved function between stages and the
potential for better eventual range of motion.
Chronic infections in TKA have been tra-
control and postoperative function for an articulating all-
cement antibiotic spacer fashioned intraoperatively from
prefabricated silicone molds.
We retrospectively reviewed 60 patients with an
infected TKA using the same cement-on-cement articu-
lating spacer. A minimum of 4 g antibiotic per package of
cement was used when making the spacer. Complications
and pre- and postoperative knee flexion, extension, and
Knee Society scores were recorded. Bone loss associated
with the spacer was determined radiographically and
by intraoperative inspection of the bony surfaces at the
second stage. Minimum followup was 24 months (mean,
35 months; range, 24–51 months).
Seven patients (12%) became reinfected, four
with an organism different from that identified at the index
resection arthroplasty. One spacer femoral component
broke between stages but did not require any specific
treatment. We identified no bone loss between stages and
no complications related to the cement-on-cement articu-
lation. The mean pretreatment Knee Society scores of 53
improved to 79. The mean preoperative flexion of 90.68
improved to 101.38 at final followup.
An articulating antibiotic spacer was asso-
ciated with control of a deep periprosthetic infection in
88% of patients while allowing range of motion between
We determined the rates of infection
One of the authors (KRB) is a consultant for and has received research
support and royalties for intellectual property from Biomet, Inc
(Warsaw, IN) andisa consultant forSynvasive(Reno, NV)andSalient
Surgical (Portsmouth, NH). One of the authors (GRK) is a consultant
for Biomet. One of the authors (ACG) is a consultant for Biomet,
Wright Medical Technology, Inc (Arlington, TN), DePuy
Orthopaedics, Inc (Warsaw, IN), and BrainLab (Westchester, IL). One
of the authors (AVL) is a consultant for and has received research
support and royalties for intellectual property from Biomet and has
received royalties from Innomed (Savannah, GA). One of the authors
(CJDV) is a consultant for Biomet, Kinamed (Camarillo, CA), Smith
and is on the advisory board for CD Diagnostics (Philadelphia, PA).
They have also received research support from Zimmer (Warsaw, IN).
Each author certifies that his or her institution approved the human
protocolforthisinvestigation, thatallinvestigations were conductedin
conformity with ethical principles of research, and that informed
consent for participation in this study was not required.
Study data collected at Rush University Medical Center, Chicago, IL;
Joint Implant Surgeons, New Albany, OH; and Hartzband Center for
Hip and Knee Replacement, Paramus, NJ.
G. S. Van Thiel, C. J. Della Valle (&)
Rush University Medical Center, 1611 West Harrison Street,
Suite 300, Chicago, IL 60612, USA
K. R. Berend, A. V. Lombardi
Joint Implant Surgeons, New Albany, OH, USA
G. R. Klein
Hartzband Center for Hip and Knee Replacement,
Paramus, NJ, USA
A. C. Gordon
Illinois Bone and Joint Institute, Chicago, IL, USA
Clin Orthop Relat Res (2011) 469:994–1001
Level of Evidence
Guidelines for Authors for a complete description of levels
Level IV, therapeutic study. See
Infection in TKA creates a difficult paradox for the treating
surgeon, because patient function must be balanced with
infection eradication. For chronic infections, Insall et al.
 first proposed a two-stage exchange protocol with
resection of the prosthesis without a spacer combined
with parenteral antibiotics; this regimen controlled the
infection in 91% of patients at 34 months. However, three
patellectomies in 11 cases were performed with two of
them being necessary for exposure at reimplantation.
Furthermore, the patients were unable to weightbear dur-
ing treatment. Wilde and Ruth  and Booth et al. 
subsequently modified the technique to include the
implantation of a static antibiotic-impregnated spacer block
after the first-stage de ´bridement and reported similar
infection control rates of 80% and 96%, respectively, with
improved function. Thus, a two-stage approach with the
use of a temporary antibiotic spacer has become the
treatment of choice in North America for chronically
A variety of techniques have been proposed for fash-
ioning a cement spacer after the first-stage de ´bridement.
Static spacers have been associated with potential prob-
lems, including difficulty in exposure at the time of the
second-stage reimplantation, bone loss [3, 8], extensor
mechanism contracture, decreased patient ambulatory
function and satisfaction, and stiffness after the second-
stage reimplantation [6, 8]. Thus, in recent years, there has
been interest in mobile antibiotic spacers that allow for
knee ROM. Multiple reports have described a number of
different techniques that all show acceptable rates of
infection control while facilitating mobilization during
treatment and showing substantial improvements in ROM
postoperatively [5, 7–9, 12, 13, 18, 21].
Recently, commercially available molds have become
available (Stage One; Biomet, Warsaw, IN) that facilitate
the production of an articulating spacer that is made from
bone cement (Fig. 1). In addition to allowing for knee
ROM between stages, benefits of these molds include the
ability to mix the type and amount of antibiotics the sur-
geon believes is appropriate, sizing of the components is
both independent and consistent, stability can be obtained
by varying the thickness of the tibial component, and no
metal or plastic is introduced into the joint that could act as
a nidus for persistent infection. Concerns include potential
complications related to the cement on cement articulation
and the cost of the molds.
We therefore determined (1) the rate of infection con-
trol; (2) ease of the surgical exposure at the time of
reimplantation; (3) ROM achieved after reimplantation;
and (4) complications associated with articulating spacers
made with these molds.
Patients and Methods
This is a retrospective case series that includes 65 con-
secutive patients with an infected TKA treated at three
institutions with the same cement-on-cement articulating
spacer between 2005 and 2007. Patients were included in
the study if the arthroplasty was deemed to be infected
based on the results of joint cultures, presence of a sinus
tract or gross purulence seen intraoperatively, and histo-
pathologic evidence of acute inflammation consistent with
infection. Articulating spacers were used when the oper-
ating surgeon believed there was adequate bone to support
an articulating spacer and that the soft-tissue envelope
could tolerate postoperative ROM; no other technique for
creation of an articulating spacer was used by the authors
during the time period of the study. Five patients were lost
Fig. 1 A photograph shows the molds used for fabrication of
antibiotic cement articulating components
Volume 469, Number 4, April 2011Antibiotic Spacers for Infected TKA 995
to followup before the 2-year minimum, leaving 60 patients
available for study. Minimum followup was 24 months
(mean, 35 months; range, 24–51 months). The patients
included 29 women and 31 men with a mean age of
66 years (range, 42–91 years). The mean number of prior
TKAs was 2.0 (range, 1–7). Institutional Review Board
approval was obtained at all three study sites.
The preoperative evaluation included determination of
ROM and Knee Society scores . Intraoperative culture
results at the time of the first-stage procedure were available
for 59 of the 60 patients (Table 1). The most common
infecting organisms were methicillin-resistant Staphylo-
coccus aureus (20%, 12 patients), methicillin-susceptible
S. aureus (20%, 12 patients), coagulase-negative S. aureus
(10%, seven patients), and a-hemolytic Streptococcus
(5%, three patients). Operative cultures were negative in
18 cases; however, all of these cases had definitive evidence
of infection with a draining sinus, gross purulence seen at
the time of resection arthroplasty, or permanent histopa-
thology consistent with infection (a mean of greater than
10 polymorphonuclear cells per high-power field). All
patients were treated with organism-specific intravenous
antibiotic therapy in consultation with an infectious disease
All surgery was performed by one of four surgeons
(CDV, KRB, AVL, GRK). A similar surgical technique was
used at all three centers. The initial procedure consisted of a
thorough de ´bridement of infected and devitalized tissue
with hardware and cement removal. The residual bony
surfaces of the femur and tibia were meticulously de ´brided
and bony cuts freshened with a saw. After removal of the
patellar component and any associated cement, the patella
was left unresurfaced between stages. In all patients, we
used an all-cement spacer fashioned intraoperatively using
silicone molds (Stage One; Biomet, Inc). The femoral
molds are available in four sizes in 5-mm increments and
were selected intraoperatively based on a comparison to the
femoral component removed and patient anatomy. The
femoral mold is made first by injecting antibiotic-loaded
cement into the mold and allowing it to harden. Tibial
molds are similarly available in four sizes in 5-mm incre-
ments, and the appropriate size was selected to provide
coverage for the cut surface of the tibia. Spacer blocks are
then used to determine the size of the flexion and extension
gaps and the tibial spacer was made to a thickness 2 to
4 mm thinner than the determined gap size to facilitate both
knee ROM and a small cement mantle for fixation of the
spacer while maintaining knee stability (Fig. 1).
A minimum of 4 g of antibiotics per package of cement
(but up to 8 g in some cases) was used in all cases. Thirty-
five patients received a mixture of tobramycin and vanco-
mycin, whereas 25 patients received gentamicin and
vancomycin. The femoral and tibial canals were opened,
de ´brided, and subsequently filled with dowels of antibiotic-
loaded cement in 55 of the 60 patients (92%). When
present, these intramedullary dowels were routinely
attached to the femoral and tibial components to both
augment stability of the components and to provide high
local concentrations of antibiotics. Once the cement spac-
ers and dowels had fully hardened, one additional package
of antibiotic-loaded cement was used to loosely cement the
components in place with the tourniquet deflated to
encourage a ‘‘poor’’ cement mantle with blood interposed
between the cement and bone. This was performed in the
later stages of hardening to facilitate removal at the second-
stage procedure (Fig. 2).
The postoperative protocol after the first stage differed
for each surgeon. Thirty-nine patients were braced and
21 patients were not braced postoperatively. Of the patients
braced, 20 patients were placed in a hinged knee brace and
allowed ROM from 0? to 60? or 90?; 14 patients were
placed in a knee immobilizer worn only at night and five
patients were placed in a knee immobilizer at all times.
Thirty-nine patients were allowed to be touch-down or
partial weightbearing, 16 were weightbearing as tolerated,
and five were nonweightbearing.
The second stage was performed at a mean of 75 days
after the first stage (range, 30–326 days) and included a
reimplantation in 58 patients, a second de ´bridement in one
patient, and a knee fusion in one patient whose extensor
mechanism was chronically disrupted. The definitive
implants included 18 Zimmer LCCKs, 32 Vanguard SSKs,
two Vanguard PSs, one Smith and Nephew Legion, one
Vanguard OSS, three Link Endo RHs, and one DePuy
MBT revision. In total, one distal femoral replacement,
four rotating hinges, and 53 stemmed components were
used. A medial gastrocnemius flap was performed con-
comitantly with the first-stage resection arthroplasty in two
patients with complex wounds and a draining sinus. A third
Table 1. Microbiology results before spacer
OrganismNumber of patients
Methicillin-resistant Staphylococcus aureus 12
Methicillin-susceptible S. aureus 12
Coagulase-negative Staphylococcus epidermidis
Group B Streptococcus1
Culture negative 18
996Van Thiel et al. Clinical Orthopaedics and Related Research1
patient had a gastrocnemius flap at the time of a second
de ´bridement procedure.
After the second-stage procedure, patients were allowed
to weightbear as tolerated and ROM exercises were initi-
ated along with quadriceps strengthening exercises that
were supervised by a physiotherapist for a minimum of
6 weeks. Physiotherapy was initially performed in the
hospital and then on an outpatient basis a minimum of three
times per week.
Patients at all three centers were evaluated at least once
within the first 6 weeks and then at approximately
3 months, 1 year, and yearly thereafter. At each visit, the
wound was assessed for healing or any overt signs of
infection (such as a sinus tract), radiographs were obtained
(including at a minimum a weightbearing AP, lateral, and
patellar views), and a physical examination was performed
that assessed knee ROM and stability. No specific labora-
tory testing for infection recurrence was performed in
patients who were not symptomatic (eg, pain) or who did
not have any overt signs of infection. Knee flexion,
extension, and Knee Society scores were recorded at the
most recent followup.
Patients were assessed for the presence of complications
related to the spacer, including dislocation, breakage,
reaction to the cement-on-cement articulation, and bone
loss related to the spacer. Bone loss was assessed by
comparing the radiographs obtained after the first stage with
the radiographs obtained before the second stage and by
intraoperatively assessing the bone behind the spacer at the
time of their removal. The operative approach used at the
time of reimplantation (standard medial parapatellar as
opposed to the need for a more extensile approach such as
quadriceps snip or a tibial tubercle osteotomy) was recorded
as a proxy for exposure difficulty. Recurrent infection was
defined as any additional surgery related to infection, a
culture of the joint that showed bacterial growth, or the
development of overt signs of infection such as a sinus tract.
The most recent radiographs were reviewed by one of
three observers (CDV, GVT, KRB) to evaluate for pros-
thetic loosening in the zones as defined by the Knee
Society and modified by Whaley et al.  to allow for
evaluation of stemmed revision components.
Continuous variables including comparisons of pre and
postoperative knee extension, knee flexion and knee soci-
ety scores were compared using a paired Student’s t test.
At an average of 35 months, seven patients (12%) had
become reinfected; reinfection occurred at a mean of
16.3 months after the reimplantation procedure (range,
Fig. 2A–B (A)APand(B)lateral
radiographs show the articulating
Volume 469, Number 4, April 2011 Antibiotic Spacers for Infected TKA997
2–30 months) (Table 2). Two of these patients were
infected with the same initial organism, one patient was
culture-negative despite gross purulence seen at the time of
reoperation, and four patients were infected with a new
organism. Four patients were managed with a second two-
stage exchange with component removal and placement of
a second antibiotic spacer. The remaining three patients
were managed with an open de ´bridement and polyethylene
exchange; two of these were acute hematogenous infec-
tions and one was determined intraoperatively to be a
superficial infection without deep extension. The reinfec-
tion subset of patients had a greater (p = 0.026) number of
prior surgeries (mean, 3.4; range, 1–6) than the cohort
overall (mean, 2.0; range, 1–7).
A standard medial parapatellar approach was used for all
patients except one in whom a quadriceps snip was per-
formed; no patient had a tibial tubercle osteotomy.
The mean extension before placement of the spacer was
3.2? (range, 0?–30?) and a mean of 2.0? at final followup
(range, 0?–10?); the mean pretreatment flexion of 90.6?
(range, 10?–125?) improved to a mean of 101.3? (range,
0?–130?) at final followup (Table 3). The mean pretreat-
ment Knee Society score of 53 (range, 10–100) improved
to a mean of 79 (range, 37–100) at most recent followup.
At final radiographic followup, none of the revi-
sion components were radiographically loose. The one
mechanical complication identified was breakage of one of
the antibiotic spacers (a femoral component fracture in the
sagittal plane) that was noted radiographically between
stages but required no specific treatment. There were no
complications observed related to the cement-on-cement
articulation and no evidence of bone loss associated with
use of the spacer. As noted, one patient had a second
de ´bridement and a second articulating spacer before
definitive reimplantation. That patient had a de ´bridement
with component retention attempted before the two-stage
exchange and initially presented with a draining sinus.
A medial gastrocnemius flap was performed at the time of
the second articulating spacer and the wound healed
uneventfully. A second patient with superficial skin com-
promise had a local advancement flap before definitive
reimplantation while the spacer was in place.
Although the use of an interim articulating spacer is
attractive, their use can only be justified if an acceptable
rate of infection control can be realized. Like with any new
surgical technique (such as we describe), theoretical
advantages may not be realized and unanticipated com-
plications can occur. Thus, we wanted to examine our early
experience with this spacer to determine (1) the rate of
infection control; (2) ease of the surgical exposure at the
Table 2. Failures with reinfection
Initial cultureTime to
20Methicillin-resistant S. aureusAcute hematogenous infection;
23 S. aureus13Streptococci agalactiae Components removed and second spacer
34 Serratia marcescens30Streptococci Components removed and second spacer
46 Methicillin-resistant S. aureus2 Methicillin-resistant S. aureusSuperficial infection
54 Escherichia coli 15E. coli Components removed and second spacer
61Staphylococcus epidermidis 13 No growthDe ´bridement with component retention
75 Culture negative 21Methicillin-susceptible S. aureus Components removed and second spacer
Table 3. Motion and function before and after two-stage revision using an articulating spacer
ParameterAverage SDAverage SDSignificance
± 3.7p = 0.269
Flexion± 31.2± 18.9p = 0.025
p\0.001 Knee Society score± 20.6± 17.8
(\59) 10 patients Knee Society score(90–100) 21 patients (70–89) 23 patients(60–69) 6 patients
998Van Thiel et al. Clinical Orthopaedics and Related Research1
time of reimplantation; (3) ROM achieved after reim-
plantation; and (4) complications associated with the
We recognize limitations to our study. First, we used
only one technique and thus direct comparisons to other
techniques or implants cannot be made. Second, this is a
multicenter retrospective review and thus the surgical
technique and postoperative management were not identi-
cal at the different sites. Third, we did not specifically test
asymptomatic patients for infection recurrence (with test-
ing such as blood work or aspiration of the joint) and thus
we may have missed some infection recurrences that were
low-grade or not clinically symptomatic. Finally, although
not a limitation of our study per se, the spacer described
may have a higher cost than the use of a static spacer or one
that is made by hand; however, facilitation of the second
stage with the potential for decreased operative time may
balance the increased costs at the first-stage procedure.
The most essential outcome measure for any treatment
protocol of a deep periprosthetic infection is eradication of
infection (Table 4). We report an 88% rate of infection
control in a relatively complex set of patients with a sub-
stantial number of multiply operated knees and infecting
organisms that were resistant to standard antibiotics. Our
rate is similar to that with other series [1, 12, 14, 15, 20].
Haddad et al.  reported 45 patients followed for an
average of 48 months with the PROSTALAC1system,
which includes femoral and tibial components made of
antibiotic-loaded bone cement with a small metal-on-
polyethylene articular surface (this device is not FDA-
approved in the United States), and found that 91% of
patients cleared the infection. Meek et al.  substantiated
these results by reporting a 96% infection control rate at a
minimum of 2 years in 58 patients. Durbhakula et al. 
has also used prefabricated molds to create articulating
antibiotic cement spacers and showed a 92% infection-free
rate in 24 patients at an average of 33 months. Hofman
et al. [12, 13] described an approach that differed from the
fabrication of articulating spacers. It included a resteril-
ization of the previously infected femoral component and
cementing it in place loosely with high-dose antibiotic
cement and a new polyethylene tibial insert. At an average
of 73 months, the authors reported an 88% infection-free
rate. Various authors have shown similar rates of infection
control with this technique [1, 4, 6, 19]; however, some
surgeons have concerns regarding the implantation of
metal and polyethylene in the setting of an established
Table 4. Results of static and articulating antibiotic spacers
Type of spacerStudyNumber
Static Booth and Lotke 251 25 months (6–59 months)Average flexion = 100
ROM static = 94?, mobile = 108?
Bone loss seen in static group
Flexion = 98? in static group and
105? in articulating
Average ROM 6?–81?
34 knees required augments and
5 required allograft at replant.
Average ROM = 90?
Emerson et al. 262 7.5 years (2.8–12.7 years)
Fehring et al. 253 36 months (24–72 months)
Wilde and Ruth  152 2.9 years (1–6 years)
Haleem et al. 9697.2 yrs (2.5–13 years)
Cement-on-cement Durbhakula et al. 242 33 months (28–51 months) Average knee flexion = 104?
Bone loss seen in static group
Flexion = 98? in static group
and 105? in articulating
Average ROM 94?
Average ROM 2-111?
Average ROM 112?
ROM static = 94?, mobile = 108?
PROSTALAC, average ROM 3?–95?
Average ROM 5?–106?
Average ROM 4?–104?
Average ROM 104?
PROSTALAC, average ROM 87?
Fehring et al.  151 27 months (24–36 months)
Pitto et al.  190 24 months (12–43 months)
Cement-on-polyethyleneEvans  312 Minimum of 2 years
Metal on polyethylene
Cuckler  441 Minimum of 1 year
Emerson et al.  222 3.8 years (2.8–6.4 years)
Haddad et al. 454 48 months (20–112 months)
Hofmann et al. 260 31 months (12–70 months)
Hofmann et al. 506 73 months (24–150 months)
Ja ¨msen et al. 222 32 months (2–86 months)
Meek et al.  472 Average 41 months
Volume 469, Number 4, April 2011 Antibiotic Spacers for Infected TKA999
One of the purported benefits of an articulating spacer is
that it allows ROM during the interval between stages. In
our experience, this not only increases patient comfort and
function, but is also associated with a straightforward
exposure at the time of reimplantation when compared with
a static spacer. In our study, one quadriceps snip exposure
was necessary, whereas the remaining revisions were
completed with a standard medial parapatellar approach.
This is similar to the findings of Durbhakula et al.  and
Fehring et al.  with only two of 24 and two of 30 patients,
respectively, requiring an extensible exposure at the time of
reimplantation when an articulating spacer was used.
Immobilization during static spacer treatment can lead
not only to soft tissue contractures, but also to permanent
decreases in ROM. In a systematic review by Jamsen et al.
, articulating spacers were associated with the greatest
increase in final ROM. Emerson et al.  also showed in a
direct comparison that articulating spacers resulted in a
greater final ROM than static spacers. Similarly, we dem-
onstrated an increase in ROM with patients increasing from
90.68 of flexion to 101.3? at final followup.
Among the potential problems with a static antibiotic-
loaded spacer is periarticular bone loss. Calton et al. 
reported a 40% rate of tibial and a 44% rate of femoral
bone loss in 25 patients treated with a static spacer. Fehring
et al.  substantiated these results in a retrospective
comparison of handmade cement articulating spacers
with a static spacer block technique. They found 15 of
25 patients (60%) in the static subset had bone loss directly
related to the spacer with none identified in the articulating
group. Our results are similar to those reported by Fehring
et al.  because no bone loss was identified in association
with the articulating spacer used in our series.
The spacer we used was not without problems; specifi-
cally, femoral component breakage occurred in one patient.
Although this complication did not compromise treatment
and was managed without specific surgical intervention, we
believed this was related to implanting the spacer too
tightly and thus we presently recommend fashioning a
tibial component that is 2 to 4 mm smaller than the mea-
sured size of the flexion and extension gaps to avoid this
potential problem. In addition, although tibiofemoral joint
dislocation was not observed in the cohort described in this
report, we have experienced this complication. This can be
avoided with proper soft tissue balance and intraoperative
trialing of the components combined with limiting patient
flexion with a brace if deemed necessary intraoperatively.
Finally, although the use of a cement-on-cement articula-
tion is a potential concern, we were unable to identify any
adverse events associated with the temporary use of this
The advantages of the articulating antibiotic spacer
system described in this report lies in the ability to
customize both the sizes of the femoral and tibial compo-
nents, select an appropriate tibial component thickness to
optimize stability and ROM, and select the amount and
type of antibiotics used in the cement. No metal hardware
is retained that could serve as a further nidus for infection,
and the patient is allowed functional ROM during treat-
ment. This ROM facilitates reimplantation (as evidenced
by the need for a quadriceps snip in only one patient)
through continued mobilization of soft tissues and the
prevention of contractures. In addition, patient ambulation
and mobilization during the spacer stage are theoretically
improved because the knee has more motion and weight-
bearing is often allowed.
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Volume 469, Number 4, April 2011 Antibiotic Spacers for Infected TKA1001