Proposed definitions for prosthetic joint infection (PJI)

2011 Musculoskeletal Infection Society (MSIS) criteria^[1]
PJI is present when 1 major criteria exist or 4 out of 6 minor criteria exist
Major criteria: 2 positive periprosthetic cultures with phenotypically identical organisms A sinus tract communicating with the joint
Minor criteria: Elevated CRP and ESR Elevated synovial fluid WBC count or ++ change on leukocyte esterase test strip Elevated synovial fluid PMN% Presence of purulence in the affected joint Positive histologic analysis of periprosthetic tissue A single positive culture
2013 International Consensus Meeting (ICM) criteria^[2]
PJI is present when 1 major criteria exist or 3 out of 5 minor criteria exist
Major criteria: 2 positive periposthetic cultures with phenotypically identical organisms A sinus tract communicating with the joint
Minor criteria: Elevated CRP and ESR Elevated synovial fluid WBC count or ++ changed on leukocyte esterase test strip Elevated synovial fluid PMN% Positive histologic analysis of periprosthetic tissue A single positive culture
2013 Infectious Disease Society of America (IDSA) guidelines^[3]
PJI is present when 1 of the following criteria exist: Sinus tract communicating with prosthesis Presence of purulence Acute inflammation on histopathologic evaluation of periprosthetic tissue 2 or more positive cultures with same organism (intraoperatively and/or preoperatively) Single positive culture with virulent organism
2018 International Consensus Meeting (ICM) criteria^[4]
Major criteria (at least 1 of the following)			Decision
2 positive cultures of the same organism Sinus tract with evidence of communication to the joint or visualization of the prosthesis			Infected
Preoperative diagnosis
Minor criteria		Score	Decision
Serum			≥6 = Infected 2 to 5 = Possibly infected* 0 to 1 = Not infected
Elevated CRP OR D-Dimer		2
Elevated ESR		1
Synovial fluid
Elevated synovial WBC count OR leukocyte esterase		3
Positive alpha-defensin		3
Elevated synovial PMN%		2
Elevated synovial CRP		1
Intraoperative diagnosis
Inconclusive preoperative score OR dry tap*		Score	Decision
Preoperative score		–	≥6 = Infected 4 to 5 = Inconclusive^¶ ≤3 = Not infected
Positive histology		3
Purulence		3
Single positive culture		2
2021 European Bone and Joint Infection Society (EBJIS) criteria^[5]
	Infection unlikely (all findings negative)	Infection likely (2 findings positive)^Δ	Infection confirmed (any positive finding)
Clinical and blood workup
Clinical features	Clear alternative reason for implant dysfunction (eg, fracture, implant breakage, malposition, tumor)	Radiologic signs of loosening within the first 5 years after implantation Previous wound healing problems History of recent fever or bacteremia Purulence around the prosthesis^◊	Sinus tract with evidence of communication to the joint or visualization of the prosthesis
C-reactive protein		>10 mg/L (1 mg/dL)^§
Synovial fluid cytological analysis^¥
Leukocyte count^§ (cells/µL)	≤1500	>1500	>3000
PMN (%)^§	≤65%	>65%	>80%
Synovial fluid biomarkers
Alpha-defensin^‡			Positive immunoassay or lateral-flow assay^‡
Microbiology^†
Aspiration fluid		Positive culture
Intraoperative (fluid and tissue)	All cultures negative	Single positive culture**	≥2 positive samples with the same microorganism
Sonication^¶¶ (CFU/mL)	No growth	>1 CFU/mL of any organism**	>50 CFU/mL of any organism
Histology^§^,^ΔΔ
High-power field (400× magnification)	Negative	≥5 neutrophils in a single high-power field	≥5 neutrophils in ≥5 high-power fields
			Presence of visible microorganisms
Others
Nuclear imaging	Negative 3-phase isotope bone scan^§	Positive WBC scintigraphy^◊◊

The 2011 MSIS diagnostic criteria are relatively straightforward and remain widely used; the 2021 EBJIS criteria are likely to be adopted widely in Europe. The 2018 ICM diagnostic criteria proposed a score-based definition for PJI with inclusion of synovial fluid parameters as minor criteria; however, these criteria include use of alpha-defensin and synovial fluid leukocyte esterase, which are not routinely available.

PJI: prosthetic joint infection; CRP: C-reactive protein; ESR: erythrocyte sedimentation rate; WBC: white blood cell; PMN%: polymorphonuclear neutrophils percentage; CFU: colony-forming unit; RBC: red blood cell.
* For patients with inconclusive minor criteria, operative criteria can also be used to fulfill definition for PJI.
¶ Consider further molecular diagnostics such as next-generation sequencing.
Δ Infection is only likely if there is a positive clinical feature or raised serum CRP, together with another positive test (synovial fluid, microbiology, histology or nuclear imaging).
◊ Except in adverse local tissue reaction and crystal arthropathy cases.
§ Should be interpreted with caution when other possible causes of inflammation are present: gout or other crystal arthropathy, metallosis, active inflammatory joint disease (eg, rheumatoid arthritis), periprosthetic fracture, or the early postoperative period.
¥ These values are valid for hips and knee PJI. Parameters are only valid when clear fluid is obtained and no lavage has been performed. Volume for the analysis should be >250 µL, ideally 1 mL, collected in an ethylenediaminetetraacetic acid-containing tube and analyzed in <1 h, preferentially using automated techniques. For viscous samples, pre-treatment with hyaluronidase improves the accuracy of optical or automated techniques. In case of bloody samples, the adjusted synovial WBC = synovial WBC_observed – [WBC_blood / RBC_blood × RBC_{synovial fluid}] should be used.
‡ Not valid in cases of adverse local tissue reaction, hematomas, or acute inflammatory arthritis or gout.
† If antibiotic treatment has been given (not simple prophylaxis), the results of microbiological analysis may be compromised. In these cases, molecular techniques may have a place. Results of culture may be obtained from preoperative synovial aspiration, preoperative synovial biopsies or (preferred) from intraoperative tissue samples.
** Interpretation of single positive culture (or <50 CFU/mL in sonication fluid) must be cautious and taken together with other evidence. If a preoperative aspiration identified the same microorganism, they should be considered as 2 positive confirmatory samples. Uncommon contaminants or virulent organisms (eg, Staphylococcus aureus or Gram negative rods) are more likely to represent infection than common contaminants (such as coagulase-negative staphylococci, micrococci, or Cutibacterium acnes).
¶¶ If centrifugation is applied, then the suggested cut-off is 200 CFU/mL to confirm infection. If other variations to the protocol are used, the published cut-offs for each protocol must be applied.
ΔΔ Histological analysis may be from preoperative biopsy, intraoperative tissue samples with either paraffin, or frozen section preparation.
◊◊ WBC scintigraphy is regarded as positive if the uptake is increased at the 20-hour scan, compared to the earlier scans (especially when combined with complementary bone marrow scan).

References:

Parvizi J, Zmistowski B, Berbari EF, et al. New definition for periprosthetic joint infection: from the Workgroup of the Musculoskeletal Infection Society. Clin Orthop Relat Res 2011; 469:2992.
Parvizi J, Gehrke T, Chen AF. Proceedings of the International Consensus Meeting on Periprosthetic Joint Infection. Bone Joint J 2013; 95:1450.
Osmon DR, Berbari EF, Berendt AR, et al. Diagnosis and management of prosthetic joint infection: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2013; 56:e1.
Original figure modified for this publication. From: Parvizi J, Tan TL, Goswami K, et al. The 2018 Definition of Periprosthetic Hip and Knee Infection: An Evidence-Based and Validated Criteria. J Arthroplasty 2018; 33:1309. Table used with the permission of Elsevier Inc. All rights reserved.
Republished with permission of The British Editorial Society of Bone & Joint Surgery, from: McNally M, Wouthuyzen-Bakker M, Chen AF, et al. The EBJIS definition of periprosthetic joint infection. Bone Joint J 2021; 103:18; permission conveyed through Copyright Clearance Center, Inc.

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Proposed definitions for prosthetic joint infection (PJI)