Should single- or two-stage revision surgery be used for the … · 2014-03-02 · (TKR) is one of...

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Critical review Page 1 of 8 Should single- or two-stage revision surgery be used for the management of an infected total knee replacement? A critical review of the literature ND Clement * , R Burnett, SJ Breusch Compeng interests: none declared. Conflict of Interests: none declared. All authors contributed to the concepon, design, and preparaon of the manuscript, as well as read and approved the fi nal manuscript. All authors abide by the Associaon for Medical Ethics (AME) ethical rules of disclosure. Licensee OA Publishing London 2013. Creative Commons Attribution Licence (CC-BY) For citation purposes: Clement ND, Burnett R, Breusch SJ. Should single- or two-stage revision surgery be used for the management of an infected total knee replacement? A critical review of the literature. OA Orthopaedics 2013 May 01;1(1):2. Abstract Introduction A post-operative periprosthetic in- fection of total knee replacement (TKR) is one of the most devastating complications for a patient to endure after surgery and is a challenge for the orthopaedic surgeon to treat. In this paper, we present the current ev- idence to support a single-stage revi- sion of a TKR for periprosthetic infec- tion and compare the outcome with that of a two-stage revision proce- dure. In addition, we also outline the methods of diagnosis used to identify a periprosthetic infection of a TKR. Conclusion The current evidence-based surgical options to manage periprosthetic in- fection do not offer a 100% guaran- tee of eradication of the infection. As to whether a single- or a two-stage procedure should be undertaken needs to be personalized to each pa- tient and their circumstances. Introduction A post-operative periprosthetic in- fection (PPJI) of total knee replace- ment (TKR) is one of the most dev- astating complications for a patient to endure after surgery and is a chal- lenge for the orthopaedic surgeon to treat. The rate of periprosthetic infec- tion of TKR varies and is dependent upon the length of follow-up, but it is generally accepted that the rate is between 0.4% and 2% 1 . This rate is however increased for patients who have specific comorbidities and for those undergoing revision surger- ies 2 . Potentially, such an infection can lead to loss of limb or life, and will likely require revision surgery. The type and extent of the revision surgery are diverse and dependent upon the patient’s circumstances and time of presentation from initial sur- gery 3 . Multiple management options are open to the orthopaedic surgeon treating such infection, but some are accepted while others remain contro- versial. In this paper, we present the evidence to support a single (one)- stage revision for periprosthetic in- fection of a TKR; however, this inter- vention is only indicated for specific case scenarios, and a knowledge of the diagnosis and classification of such an infection is essential and will be discussed first. Pathology and microbiology The majority, approximately half, of microorganisms infecting knee prostheses are the different strains of Staphylococci, with coagulase- negative Staphylococci being the most common, accounting for approxi- mately 27% of infections and Staphy- lococcus aureus being second and responsible for 23% of infections 3 . The microorganism attaches itself to the surface of the prosthesis and pro- duces a biofilm, which forms between 36 h and 3 weeks. There are four con- secutive steps in biofilm formation: adherence to the surface of prosthesis, production of the biofilm, maturation of the biofilm, and finally its detachment and spread of the microorganisms, which then result in overwhelming in- fection of the prosthesis clinically 4 . The biofilm blocks the body’s natural im- mune defence mechanisms, and the microorganisms exist in a planktonic form within their protected environ- ment of extracellular matrix made of different polysaccharide molecules, proteins and extracellular DNA, and replicate slowly; these are termed sessile bacteria. The ability of the pathogen to produce a biofilm de- fines its virulence in prosthetic in- fection, being resistant to antibiotics with a minimal inhibitory concen- trate that can be elevated up to 1000 times with the biofilm 5 . Commensal bacteria, such as coagulase-negative Staphylococci are more frequent in immediate and early prosthetic infec- tions, when spread from the surgical wound edges and in late low-grade infections. In late infections by hae- matogenous spread, Staphylococcus aureus is the most important caus- ative factor 6 . Diagnosis The key to effectively managing pa- tients with a prosthetic infection of a TKR is early and accurate diagno- sis. The presentation can, however, be varied and a definitive diagnosis may be challenging. There is no de- finitive single test to establish a diag- nosis, and relies on a combination of clinical signs and symptoms, labora- tory investigations and radiographic studies. Clinical signs and symptoms There is a vast spectrum of clinical presentations of patients suffering with a prosthetic joint infection 7 , which can vary from systemic sep- sis to chronic indolent low-grade infection. The patient may complain *Corresponding author E-mail: [email protected] Department of Orthopaedics and Trauma, The Royal Infirmary of Edinburgh, Little France, Edinburgh EH16 4SA, UK Diagnosis & Treatment

Transcript of Should single- or two-stage revision surgery be used for the … · 2014-03-02 · (TKR) is one of...

Page 1: Should single- or two-stage revision surgery be used for the … · 2014-03-02 · (TKR) is one of the most devastating complications for a patient to endure after surgery and is

Critical review

Page 1 of 8

Should single- or two-stage revision surgery be used for the management of an infected total knee replacement?

A critical review of the literature

ND Clement*, R Burnett, SJ Breusch

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Licensee OA Publishing London 2013. Creative Commons Attribution Licence (CC-BY)

For citation purposes: Clement ND, Burnett R, Breusch SJ. Should single- or two-stage revision surgery be used for the management of an infected total knee replacement? A critical review of the literature. OA Orthopaedics 2013 May 01;1(1):2.

AbstractIntroductionA post-operative periprosthetic in-fection of total knee replacement (TKR) is one of the most devastating complications for a patient to endure after surgery and is a challenge for the orthopaedic surgeon to treat. In this paper, we present the current ev-idence to support a single-stage revi-sion of a TKR for periprosthetic infec-tion and compare the outcome with that of a two-stage revision proce-dure. In addition, we also outline the methods of diagnosis used to identify a periprosthetic infection of a TKR.ConclusionThe current evidence-based surgical options to manage periprosthetic in-fection do not offer a 100% guaran-tee of eradication of the infection. As to whether a single- or a two-stage procedure should be undertaken needs to be personalized to each pa-tient and their circumstances.

IntroductionA post-operative periprosthetic in-fection (PPJI) of total knee replace-ment (TKR) is one of the most dev-astating complications for a patient to endure after surgery and is a chal-lenge for the orthopaedic surgeon to treat. The rate of periprosthetic infec-tion of TKR varies and is dependent upon the length of follow-up, but it is generally accepted that the rate is between 0.4% and 2%1. This rate is

however increased for patients who have specific comorbidities and for those undergoing revision surger-ies2. Potentially, such an infection can lead to loss of limb or life, and will likely require revision surgery. The type and extent of the revision surgery are diverse and dependent upon the patient’s circumstances and time of presentation from initial sur-gery3. Multiple management options are open to the orthopaedic surgeon treating such infection, but some are accepted while others remain contro-versial. In this paper, we present the evidence to support a single (one)-stage revision for periprosthetic in-fection of a TKR; however, this inter-vention is only indicated for specific case scenarios, and a knowledge of the diagnosis and classification of such an infection is essential and will be discussed first.

Pathology and microbiologyThe majority, approximately half, of microorganisms infecting knee prostheses are the different strains of Staphylococci, with coagulase-negative Staphylococci being the most common, accounting for approxi-mately 27% of infections and Staphy-lococcus aureus being second and responsible for 23% of infections3. The microorganism attaches itself to the surface of the prosthesis and pro-duces a biofilm, which forms between 36 h and 3 weeks. There are four con-secutive steps in biofilm formation: adherence to the surface of prosthesis, production of the biofilm, maturation of the biofilm, and finally its detachment and spread of the microorganisms, which then result in overwhelming in-fection of the prosthesis clinically4. The

biofilm blocks the body’s natural im-mune defence mechanisms, and the microorganisms exist in a planktonic form within their protected environ-ment of extracellular matrix made of different polysaccharide molecules, proteins and extracellular DNA, and replicate slowly; these are termed sessile bacteria. The ability of the pathogen to produce a biofilm de-fines its virulence in prosthetic in-fection, being resistant to antibiotics with a minimal inhibitory concen-trate that can be elevated up to 1000 times with the biofilm5. Commensal bacteria, such as coagulase-negative Staphylococci are more frequent in immediate and early prosthetic infec-tions, when spread from the surgical wound edges and in late low-grade infections. In late infections by hae-matogenous spread, Staphylococcus aureus is the most important caus-ative factor6.

DiagnosisThe key to effectively managing pa-tients with a prosthetic infection of a TKR is early and accurate diagno-sis. The presentation can, however, be varied and a definitive diagnosis may be challenging. There is no de-finitive single test to establish a diag-nosis, and relies on a combination of clinical signs and symptoms, labora-tory investigations and radiographic studies.

Clinical signs and symptomsThere is a vast spectrum of clinical presentations of patients suffering with a prosthetic joint infection7, which can vary from systemic sep-sis to chronic indolent low-grade infection. The patient may complain

*Corresponding author E-mail: [email protected]

Department of Orthopaedics and Trauma, The Royal Infirmary of Edinburgh, Little France, Edinburgh EH16 4SA, UK

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Critical review

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Licensee OA Publishing London 2013. Creative Commons Attribution Licence (CC-BY)

For citation purposes: Clement ND, Burnett R, Breusch SJ. Should single- or two-stage revision surgery be used for the management of an infected total knee replacement? A critical review of the literature. OA Orthopaedics 2013 May 01;1(1):2.

of pain, swelling, chronic soft tis-sue induration/oedema, erythema, warmth, with limitation or worsen-ing knee function and may have a discharging wound or draining sinus (Figure 1); however, most patients may only have a few of these symp-toms and signs8.

Laboratory testsThe erythrocyte sedimentation rate (ESR) and the C-reactive protein (CRP) offer excellent diagnostic infor-mation for establishing the presence or absence of prosthetic joint infec-tion. Greidanus et al.9 identified that an ESR of >22.5 mm/h and a CRP of >13.5 mg/l offered a sensitivity rate of 0.93 and 0.91, and a specificity of 0.83 and 0.86, respectively. After in-dex surgery, the CRP should return to normal within 3–6 weeks. Serum interleukin-6 is probably a more ac-curate diagnostic test, as it correlates positively with the presence of peri-prosthetic infection. Di Cesare et al.10 conducted a prospective case–control study of 58 patients undergoing re-vision surgery of total hip and knee replacements; serum Interleukin-6

values > 10 pg/ml were demonstrated to have a sensitivity of 100%, speci-ficity of 95%, positive predictive val-ue of 89%, negative predictive value of 100% and accuracy of 97%.

Knee aspirate cell and differential countsIn a patient with TKR who is sus-pected to have a prosthetic joint infection, an aspiration of the joint should be obtained. This does carry a risk of potentially infecting the TKR, if it is not already, and with such a risk this should be carried out under a strict aseptic technique in an operating theatre. Synovial fluid cell count and differential is a very useful diagnostic test. If the white cell count is greater than 1100/ml and the neutrophil percentage is 65% or more, the positive predictive value is 98.6%, whereas if both the values are below this, the negative predicted rate is 98.2%11. Antibiot-ics should be suspended, if possible, for 10–14 days before carrying out the aspiration, and should be cul-tured for at least 2 weeks as one in four cultures that are negative at

7 days will have positive growth by 14 days12.

Polymerase chain reaction (PCR)Molecular diagnosis using PCR to amplify strains of bacterial DNA en-ables identification of the potential pathogen. It can be used to identify non-viable bacteria and is thought to be a quick method, and whether a patient has received antibiotics does not affect this method. However, a high percentage of false-negative test results have been reported using such methodology13.

UltrasonicationThe biofilm formed over the surface of the implant by the microorganism can prevent growth and identifica-tion of the pathogen. Ultrasonication lyses the bacteria, making them void to culture, and then PCR can be used to identify the pathogen. Trampuz et al.14 demonstrated that cultures of samples obtained by the process from the prostheses were more sen-sitive than tissue cultures for the mi-crobiologic diagnosis of prosthetic joint infection, especially in patients

Figure 1: Multiple discharging sinuses from a chroni-cally infected TKR.

Figure 2: Lateral radiograph of an infected TKR dem-onstrating a loose femoral component.

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Critical review

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Licensee OA Publishing London 2013. Creative Commons Attribution Licence (CC-BY)

For citation purposes: Clement ND, Burnett R, Breusch SJ. Should single- or two-stage revision surgery be used for the management of an infected total knee replacement? A critical review of the literature. OA Orthopaedics 2013 May 01;1(1):2.

who had received antibiotics within 14 days of surgery.

Intra-operative frozen section and gram stainingFrozen histological sections are used to assist decision-making in cases with equivocal serum inflam-matory makers and aspirate cytol-ogy. The cut-off value of more than five neutrophils per high-power field at a magnification of 400× is commonly used for the diagnosis of infection. The sensitivity and speci-ficity are both more than 80%15. Intra-operative gram staining is an unreliable test, with a sensitivity of 27%16, and should not be used rou-tinely.

Plain radiographsPotential signs of loosening with rapidly progressive radiolucent lines surrounding an implant may be pres-ent during an infection, which can progress with resorption of subchon-

dral bone and patchy osteoporosis and eventual osteolysis (Figure 2).

Nuclear imagingA bone scan using technetium 99 can help confirm a diagnosis, but the cost is relatively high; although the

level of sensitivity is high and level of specificity remained low, its use is restricted17. A technetium bone scan remains positive more than 1 year after implantation because of in-creased periprosthetic bone remod-elling. Overall, the potential value of

Table 1. Relative contraindications to attempt single-stage revision surgery for a periprosthetic infection suggested by Oussedik et al.

Category Compromising factorLocal Significant soft tissue compromise

Significant bone loss precluding cemented fixationHost Immunosuppression

Concurrent sepsisSystemic diseaseRe-infection

Organism Multi-resistant organism (MRSA)a

Polymicrobial infectionUnusual commensalsUnusual resistance profilesUnidentified infective organism

aMethicillin-resistant Staphylococcus aureus

Figure 3: The wound before (a) and after (b) through debridement and lavage of the soft tissues and bone ends of a chronically infected TKR.

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Critical review

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Licensee OA Publishing London 2013. Creative Commons Attribution Licence (CC-BY)

For citation purposes: Clement ND, Burnett R, Breusch SJ. Should single- or two-stage revision surgery be used for the management of an infected total knee replacement? A critical review of the literature. OA Orthopaedics 2013 May 01;1(1):2.

bone scanning for the diagnosis of PPJI remains controversial.

ClassificationMultiple classifications for infected total joint replacement exist; how-ever, that described by Tsukayama et al.18 seems to be accepted by most authors. They defined four groups based upon the clinical presentation of the patient that also aids manage-ment decisions. Group one is when there are positive intra-operative cultures (two or more) obtained dur-ing the revision procedure, when

no infection was suspected pre-op-eratively. Group two infections are those that occur in the early post-operative period, within 1 month of the index procedure. Group three is a haematogenous infection, where the TKR performed well prior to the acute episode, due to seeding of the implant from a distant source. Group four includes those patients with chronic infections of their TKR that are persistent beyond 1 month after index procedure. Although not used universally, classification systems, also taking into account the host situ-

ation, are considered to be of better prognostic value19.

Surgical managementThe management of the infected TKR is complex and expensive, with an ultimate goal of eradicating the in-fection and leaving the patient with a pain-free and functioning TKR. The treatment options include: debride-ment and irrigation (+/− polyethyl-ene exchange), single- or two-stage revision, resection arthroplasty and more rarely arthrodesis or amputa-tion, or long-term antibiotic suppres-sion20. Debridement and irrigation (+/− polyethylene exchange) may be used for group 2 periprosthetic in-fections, but the success rate of this is poor, with an eradication rate of 18%–39%3. Group 3 and 4 infections can be managed with revision of the prosthesis, which may be a single- or a two-staged procedure3. Insall et al.21 first described a two-stage pro-cedure in 1983 for chronic indolent periprosthetic infections of TKRs. The first stage of this procedure is radical debridement through the original incision, with removal of the component, all cement, membranes, and infected tissue (Figure 3). Antibi-otics are withheld until multiple (at least 5) deep tissue specimens have been obtained using new instru-ments each time to ensure no cross contamination. A through lavage of the wound is then undertaken. A static [non-articulating (Figure 4)] or a dynamic (articulating) spacer, which is antibiotic laden, is then used to bridge the deficit. This is the end of the first stage, and the patient is placed on antibiotics for 6–8 weeks (depending on sensitivities from the intra-operative specimens). The pa-tient’s clinical status and inflamma-tory markers are observed for this period and after cessation of the an-tibiotics, only when the infection is thought to be eradicated is the sec-ond stage undertaken, which maybe 6 weeks to 6 months after the first stage. The second stage then entails

Table 2. Published studies reporting the outcome of the patients undergoing single-stage revision for a periprosthetic infection of their TKR

Author Year n Follow-up Survival (%)

Von Foerster et al. 1991 118 5–15 64

Goksan and Freeman 1992 18 5 94

Lu et al. 1997 8 2 100

Siegel et al. 2000 31 2–15 71

Buechel 2004 22 10 91

Soudry et al. 2009 20 8 80

Parkinson et al. 2011 12 2 100

Total 229

Average 6.1 86

Table 3. Published studies reporting the outcome of the patients undergoing two stage revision for a periprosthetic infection of their TKR

Author Year n Follow-up Survival (%)

Insall et al. 1983 11 2.8 100

Hanssen et al. 1994 89 4.3 89

Goldman et al. 1996 64 7.5 91

Gacon et al. 1997 29 3.5 83

Hirakawa et al. 1998 55 5.2 87

Haddad et al. 2000 45 4 91

Siebel et al. 2002 10 1.1 100

Pietsch et al. 2003 24 1.2 96

Haleem et al. 2004 96 7.2 91

Soudry et al. 2009 21 8 100

Total 444

Average 4.5 93

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Licensee OA Publishing London 2013. Creative Commons Attribution Licence (CC-BY)

For citation purposes: Clement ND, Burnett R, Breusch SJ. Should single- or two-stage revision surgery be used for the management of an infected total knee replacement? A critical review of the literature. OA Orthopaedics 2013 May 01;1(1):2.

re-implantation of the TKR, which may need to be a modular semi-con-strain (Figure 5) or hinged prosthe-sis due to bone and soft tissue loss. A success rate of 85% at 10 years was reported for this method of revision TKR for periprosthetic infections22. However, this two-staged procedure results in two hospital admissions, morbidity associated with the sec-

ond procedure, poor mobility and pain between the stages endured by the patient, in addition to the finan-cial implications for both the health-care service and the patient3. A sin-gle-stage revision for periprosthetic infection of a TKR is a potential alter-native that averts the second admis-sion with immediate benefit to the patient, and offers financial savings23.

DiscussionThe authors have referenced some of their own studies in this review. These referenced studies were con-ducted in accordance with the Dec-laration of Helsinki (1964) and the protocols of these studies were ap-proved by the relevant ethics com-mittees related to the institution in which they were performed. All hu-man subjects, in these referenced studies, gave informed consent to participate in these studies.

Single-stage revisionA single-stage revision is advocated by some orthopaedic surgeons in specific case scenarios23,24. Oussedik et al.25 proposed a list of potential contra-indications to a single-stage revision surgery (Table 1), however, this was based on periprosthetic infections of total hip replacements. One important criterion that is generally accepted is that the organism causing the infec-tion must be identified pre-operatively and has known antibiotic sensitivities, which enables the correct intra-ve-nous antibiotics and antibiotic loaded cement to be used at the time of sur-gery. Identical to the first part of the two-stage revision of all foreign mate-rial, synovium, prosthesis and cement are removed with through lavage of the remaining tissue. At this point, the wound is packed with ‘new’ ster-ile swabs and the wound is bandaged with release of the tourniquet. There is a short break, this gives the staff and surgeon time to change all instru-ments and re-scrub for the next part of the case. The tourniquet is re-inflated and the patient is re-draped and the second part of the single-stage revi-sion commences with re-implantation of the revision prosthesis. Antibiotics should continue throughout the peri-operative period and are prescribed according to sensitivities. Immediate rehabilitation should be commenced, with full weight bearing and range of movement exercises once the wound is considered dry.

Figure 4: A lateral radiograph of the knee demonstrating a static cement spacer that was inserted during the first part of the two-stage revision procedure.

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Licensee OA Publishing London 2013. Creative Commons Attribution Licence (CC-BY)

For citation purposes: Clement ND, Burnett R, Breusch SJ. Should single- or two-stage revision surgery be used for the management of an infected total knee replacement? A critical review of the literature. OA Orthopaedics 2013 May 01;1(1):2.

Outcome of single- versus two-stage revisionThe success rate of single-stage revi-sion for periprosthetic infection of TKR is variable and seems dependent upon the length of follow-up (Table 2, Figure 6), from 100% at 2 years23,26 to 64% at 10 years24. According to sev-en published studies, we identified from the literature the overall aver-age survival rate was 86% 6 years from the index procedure (Table 2)23,24,26–30. This pooled survival rate is not as good as that offered by two-stage revision surgery, where the overall pooled average survival for those studies reporting the outcome of such surgery is 93% at a mean of 4.5 years follow-up (Table 3)21,22,30–37. Upon pooling the data from Tables 2 and 3, there were 32 failures in the 7 studies reporting the survival after single-stage surgery and 31 for those studies reporting the survival after two-stage surgery. This data suggests that the risk of failure to eradicate the infection is significantly greater when employing a single-stage strat-egy for infection (odds ratio 2.16,

95% confidence interval 1.28–3.64, p = 0.003). However, there is only one study comparing the eradication rate between single- and two-stage procedures, which demonstrated no differences between these proce-

dures38. In addition, they did show that the single-stage had a better functional outcome. Hence, it would seem that two-stage re-implantation is the gold standard for eradication of infection in management of peri-

Figure 5: Anterior–posterior (a) and lateral (b) radiographs of a semi-constrained TKR implanted as part of a second-stage procedure for infection of a primary TKR.

Figure 6: Survival (defined and eradication of infection) of seven studies (Table 2) reporting the outcome of single-stage revision for periprosthetic infection of TKR.

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.

Licensee OA Publishing London 2013. Creative Commons Attribution Licence (CC-BY)

For citation purposes: Clement ND, Burnett R, Breusch SJ. Should single- or two-stage revision surgery be used for the management of an infected total knee replacement? A critical review of the literature. OA Orthopaedics 2013 May 01;1(1):2.

prosthetic TKR infections. However, single-stage revision is appealing for specific case scenarios that averts an additional surgical procedure and the associated patient morbidity, and may result in a better functional out-come.

ConclusionPeriprosthetic infection after TKR continues to be a devastating com-plication that has to be endured by our patients, and although the preva-lence is <2% with the increasing rate of TKR, there will be more and more patients presenting to orthopaedic services with an infected TKR. The current evidence-based surgical op-tions to manage periprosthetic infec-tion do not offer a 100% guarantee of eradication of the infection. As to whether a single- or a two-stage pro-cedure should be undertaken needs to be personalized to each patient and their circumstances. Currently, evidence would suggest that two-stage revision is the gold standard and offers more than a 90% chance of eradication of the infection. How-ever, such an undertaking results in two separate interventions that carry peri-operative morbidity and a peri-od of disability for patients between their two stages. In contrast, a single-stage procedure, in the right patient, offers a definitive intervention with immediate benefit and commence-ment of rehabilitation. Furthermore, from what little evidence exists, the functional outcome would seem to be better with the single-stage pro-cedure, but this may be influenced by multiple case-mix factors. It would seem that both single- and two-stage revision procedures for infection of TKR offer advantages and disadvan-tages to our patients. Hence, patients who would be applicable for a single-stage revision should be made aware of these risks and benefits of both op-tions, and should be engaged in the decision as to whether a single- or a two-stage revision should be un-dertaken. Despite the presented evi-dence for both procedures they only

offer partial success in eradication of infection and new modalities should be investigated.

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Licensee OA Publishing London 2013. Creative Commons Attribution Licence (CC-BY)

For citation purposes: Clement ND, Burnett R, Breusch SJ. Should single- or two-stage revision surgery be used for the management of an infected total knee replacement? A critical review of the literature. OA Orthopaedics 2013 May 01;1(1):2.

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