THE DIAGNOSIS OF PERIPROSTHETIC JOINT INFECTIONS OF THE HIP AND KNEE GUIDELINE AND EVIDENCE REPORT Adopted by the American Academy of Orthopaedic Surgeons Board of Directors June 18, 2010 Disclaimer This Clinical Practice Guideline was developed by an AAOS physician volunteer Work Group based on a systematic review of the current scientific and clinical information and accepted approaches to treatment and/or diagnosis. This Clinical Practice Guideline is not intended to be a fixed protocol, as some patients may require more or less treatment or different means of diagnosis. Clinical patients may not necessarily be the same as those found in a clinical trial. Patient care and treatment should always be based on a clinician’s independent medical judgment, given the individual patient’s clinical circumstances. Disclosure Requirement In accordance with AAOS policy, all individuals whose names appear as authors or contributors to Clinical Practice Guideline filed a disclosure statement as part of the submission process. All panel members provided full disclosure of potential conflicts of interest prior to voting on the recommendations contained within this Clinical Practice Guidelines. Funding Source This Clinical Practice Guideline was funded exclusively by the American Academy of Orthopaedic Surgeons who received no funding from outside commercial sources to support the development of this document. FDA Clearance Some drugs or medical devices referenced or described in this Clinical Practice Guideline may not have been cleared by the Food and Drug Administration (FDA) or may have been cleared for a specific use only. The FDA has stated that it is the responsibility of the physician to determine the FDA clearance status of each drug or device he or she wishes to use in clinical practice. Copyright All rights reserved. No part of this Clinical Practice Guideline may be reproduced, stored in a retrieval system, or transmitted, in any form, or by any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission from the AAOS. Published 2010 by the American Academy of Orthopaedic Surgeons 6300 North River Road Rosemont, IL 60018 First Edition Copyright 2010 by the American Academy of Orthopaedic Surgeons ii AAOS Clinical Practice Guidelines Unit v1.0 062110 Summary of Recommendations The following is a summary of the recommendations in the AAOS’ clinical practice guideline, The Diagnosis of Periprosthetic Joint Infections of the Hip and Knee. This summary does not contain rationales that explain how and why these recommendations were developed nor does it contain the evidence supporting these recommendations. All readers of this summary are strongly encouraged to consult the full guideline and evidence report for this information. We are confident that those who read the full guideline and evidence report will note that the recommendations were developed using systematic evidence-based processes designed to combat bias, enhance transparency, and promote reproducibility. This summary of recommendations is not intended to stand alone. Clinical decisions should be made in light of all circumstances presented by the patient. Procedures applicable to the individual patient rely on mutual communication between patient, physician, and other healthcare practitioners. 1. In the absence of reliable evidence about risk stratification of patients with a potential periprosthetic joint infection, it is the opinion of the work group that testing strategies be planned according to whether there is a higher or lower probability that a patient has a hip or knee periprosthetic infection. Strength of Recommendation: Consensus Description: The supporting evidence is lacking and requires the work group to make a recommendation based on expert opinion by considering the known potential harm and benefits associated with the treatment. A Consensus recommendation means that expert opinion supports the guideline recommendation even though there is no available empirical evidence that meets the inclusion criteria of the guideline’s systematic review. Implications: Practitioners should be flexible in deciding whether to follow a recommendation classified as Consensus, although they may set boundaries on alternatives. Patient preference should have a substantial influencing role. Note: Please see page 17 of this document for a definition of “higher and lower probability”. 2. We recommend erythrocyte sedimentation rate and C-reactive protein testing for patients assessed for periprosthetic joint infection. Strength of Recommendation: Strong Description: Evidence is based on two or more “High” strength studies with consistent findings for recommending for or against the intervention. A Strong recommendation means that the benefits of the recommended approach clearly exceed the potential harm (or that the potential harm clearly exceeds the benefits in the case of a strong negative recommendation), and that the strength of the supporting evidence is high. iii AAOS Clinical Practice Guidelines Unit v1.0 062110 Implications: Practitioners should follow a Strong recommendation unless a clear and compelling rationale for an alternative approach is present. 3. We recommend joint aspiration of patients being assessed for periprosthetic knee infections who have abnormal erythrocyte sedimentation rate AND/OR C- reactive protein results. We recommend that the aspirated fluid be sent for microbiologic culture, synovial fluid white blood cell count and differential. Strength of Recommendation: Strong Description: Evidence is based on two or more “High” strength studies with consistent findings for recommending for or against the intervention. A Strong recommendation means that the benefits of the recommended approach clearly exceed the potential harm (or that the potential harm clearly exceeds the benefits in the case of a strong negative recommendation), and that the strength of the supporting evidence is high. Implications: Practitioners should follow a Strong recommendation unless a clear and compelling rationale for an alternative approach is present. 4. We recommend a selective approach to aspiration of the hip based on the patient’s probability of periprosthetic joint infection and the results of the erythrocyte sedimentation rate (ESR) AND C-reactive protein (CRP). We recommend that the aspirated fluid be sent for microbiologic culture, synovial fluid white blood cell count and differential. Selection of Patients for Hip Aspiration Probability of ESR and CRP Planned Reoperation Infection Results Status Recommended Test Higher + + or + − Planned or not planned Aspiration Lower + + or + − Planned Aspiration or Frozen Section Lower + + Not planned Aspiration Lower + − Not planned Please see Recommendation 6 Higher or Lower − − Planned or not planned No further testing Key for ESR and CRP results + + = ESR and CRP test results are abnormal + − = either ESR or CRP test result is abnormal − − = ESR and CRP test results are normal Strength of Recommendation: Strong Description: Evidence is based on two or more “High” strength studies with consistent findings for recommending for or against the intervention. A Strong recommendation means that the benefits of the recommended approach clearly exceed the potential harm (or that the potential harm clearly exceeds the benefits in the case of a strong negative recommendation), and that the strength of the supporting evidence is high. iv AAOS Clinical Practice Guidelines Unit v1.0 062110 Implications: Practitioners should follow a Strong recommendation unless a clear and compelling rationale for an alternative approach is present. 5. We suggest a repeat hip aspiration when there is a discrepancy between the probability of periprosthetic joint infection and the initial aspiration culture result. Strength of Recommendation: Moderate Description: Evidence from two or more “Moderate” strength studies with consistent findings, or evidence from a single “High” quality study for recommending for or against the intervention. A Moderate recommendation means that the benefits exceed the potential harm (or that the potential harm clearly exceeds the benefits in the case of a negative recommendation), but the strength of the supporting evidence is not as strong. Implications: Practitioners should generally follow a Moderate recommendation but remain alert to new information and be sensitive to patient preferences. 6. In the absence of reliable evidence, it is the opinion of the work group that patients judged to be at lower probability for periprosthetic hip infection and without planned reoperation who have abnormal erythrocyte sedimentation rates OR abnormal C-reactive protein levels be re-evaluated within three months. We are unable to recommend specific diagnostic tests at the time of this follow-up. Strength of Recommendation: Consensus Description: The supporting evidence is lacking and requires the work group to make a recommendation based on expert opinion by considering the known potential harm and benefits associated with the treatment. A Consensus recommendation means that expert opinion supports the guideline recommendation even though there is no available empirical evidence that meets the inclusion criteria of the guideline’s systematic review. Implications: Practitioners should be flexible in deciding whether to follow a recommendation classified as Consensus, although they may set boundaries on alternatives. Patient preference should have a substantial influencing role. v AAOS Clinical Practice Guidelines Unit v1.0 062110 7. In the absence of reliable evidence, it is the opinion of the work group that a repeat knee aspiration be performed when there is a discrepancy between the probability of periprosthetic joint infection and the initial aspiration culture result. Strength of Recommendation: Consensus Description: The supporting evidence is lacking and requires the work group to make a recommendation based on expert opinion by considering the known potential harm and benefits associated with the treatment. A Consensus recommendation means that expert opinion supports the guideline recommendation even though there is no available empirical evidence that meets the inclusion criteria of the guideline’s systematic review. Implications: Practitioners should be flexible in deciding whether to follow a recommendation classified as Consensus, although they may set boundaries on alternatives. Patient preference should have a substantial influencing role. 8. We suggest patients be off of antibiotics for a minimum of 2 weeks prior to obtaining intra-articular culture. Strength of Recommendation: Moderate Description: Evidence from two or more “Moderate” strength studies with consistent findings, or evidence from a single “High” quality study for recommending for or against the intervention. A Moderate recommendation means that the benefits exceed the potential harm (or that the potential harm clearly exceeds the benefits in the case of a negative recommendation), but the strength of the supporting evidence is not as strong. Implications: Practitioners should generally follow a Moderate recommendation but remain alert to new information and be sensitive to patient preferences. 9. Nuclear imaging (Labeled leukocyte imaging combined with bone or bone marrow imaging, FDG-PET imaging, Gallium imaging, or labeled leukocyte imaging) is an option in patients in whom diagnosis of periprosthetic joint infection has not been established and are not scheduled for reoperation. Strength of Recommendation: Limited Description: Evidence from two or more “Low” strength studies with consistent findings, or evidence from a single “Moderate” quality study recommending for or against the intervention or diagnostic. A Limited recommendation means the quality of the supporting evidence that exists is unconvincing, or that well-conducted studies show little clear advantage to one approach versus another. Implications: Practitioners should be cautious in deciding whether to follow a recommendation classified as Limited, and should exercise judgment and be alert to emerging publications that report evidence. Patient preference should have a substantial influencing role. vi AAOS Clinical Practice Guidelines Unit v1.0 062110 10. We are unable to recommend for or against computed tomography (CT) or magnetic resonance imaging (MRI) as a diagnostic test for periprosthetic joint infection. Strength of Recommendation: Inconclusive Description: Evidence from a single low quality study or conflicting findings that do not allow a recommendation for or against the intervention. An Inconclusive recommendation means that there is a lack of compelling evidence resulting in an unclear balance between benefits and potential harm. Implications: Practitioners should feel little constraint in deciding whether to follow a recommendation labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify existing evidence for determining balance of benefits versus potential harm. Patient preference should have a substantial influencing role. 11. We recommend against the use of intraoperative Gram stain to rule out periprosthetic joint infection. Strength of Recommendation: Strong Description: Evidence is based on two or more “High” strength studies with consistent findings for recommending for or against the intervention. A Strong recommendation means that the benefits of the recommended approach clearly exceed the potential harm (or that the potential harm clearly exceeds the benefits in the case of a strong negative recommendation), and that the strength of the supporting evidence is high. Implications: Practitioners should follow a Strong recommendation unless a clear and compelling rationale for an alternative approach is present. 12. We recommend the use of frozen sections of peri-implant tissues in patients who are undergoing reoperation for whom the diagnosis of periprosthetic joint infection has not been established or excluded. Strength of Recommendation: Strong Description: Evidence is based on two or more “High” strength studies with consistent findings for recommending for or against the intervention. A Strong recommendation means that the benefits of the recommended approach clearly exceed the potential harm (or that the potential harm clearly exceeds the benefits in the case of a strong negative recommendation), and that the strength of the supporting evidence is high. Implications: Practitioners should follow a Strong recommendation unless a clear and compelling rationale for an alternative approach is present. vii AAOS Clinical Practice Guidelines Unit v1.0 062110 13. We recommend that multiple cultures be obtained at the time of reoperation in patients being assessed for periprosthetic joint infection. Strength of Recommendation: Strong Description: Evidence is based on two or more “High” strength studies with consistent findings for recommending for or against the intervention. A Strong recommendation means that the benefits of the recommended approach clearly exceed the potential harm (or that the potential harm clearly exceeds the benefits in the case of a strong negative recommendation), and that the strength of the supporting evidence is high. Implications: Practitioners should follow a Strong recommendation unless a clear and compelling rationale for an alternative approach is present. 14. We recommend against initiating antibiotic treatment in patients with suspected periprosthetic joint infection until after cultures from the joint have been obtained. Strength of Recommendation: Strong Description: Evidence is based on two or more “High” strength studies with consistent findings for recommending for or against the intervention. A Strong recommendation means that the benefits of the recommended approach clearly exceed the potential harm (or that the potential harm clearly exceeds the benefits in the case of a strong negative recommendation), and that the strength of the supporting evidence is high. Implications: Practitioners should follow a Strong recommendation unless a clear and compelling rationale for an alternative approach is present. 15. We suggest that prophylactic preoperative antibiotics not be withheld in patients at lower probability for periprosthetic joint infection and those with an established diagnosis of periprosthetic joint infection who are undergoing reoperation. Strength of Recommendation: Moderate Description: Evidence from two or more “Moderate” strength studies with consistent findings, or evidence from a single “High” quality study for recommending for or against the intervention. A Moderate recommendation means that the benefits exceed the potential harm (or that the potential harm clearly exceeds the benefits in the case of a negative recommendation), but the strength of the supporting evidence is not as strong. Implications: Practitioners should generally follow a Moderate recommendation but remain alert to new information and be sensitive to patient preferences. viii AAOS Clinical Practice Guidelines Unit v1.0 062110 Work Group Craig Della Valle MD, Chair Guidelines and Technology Oversight Rush University Medical Center Chair: 1611 W Harrison St # 300 William C. Watters III MD Chicago, IL 60612-4861 6624 Fannin #2600 Houston, TX 77030 Javad Parvizi, MD, Vice-Chair Rothman Institute Evidence Based Practice Committee Chair: 925 Chestnut St - 5th Fl Michael Keith, MD Philadelphia, PA 19107 2500 Metro Health Drive Cleveland, OH 44109-1900 Thomas W Bauer, MD PhD Cleveland Clinic Foundation AAOS Staff: Department of Pathology Charles M. Turkelson, PhD 9500 Euclid Ave Desk L25 Director of Research and Scientific Affairs Cleveland, OH 44195 6300 N River Road Rosemont, IL 60018 Paul E DiCesare, MD UC Davis Medical Center Janet L. Wies MPH Department of Orthopaedic Surgery AAOS Clinical Practice Guideline Mgr 4860 Y St Ste 3800 Sacramento, CA 95817 Patrick Sluka MPH AAOS Research Analyst Richard Parker Evans, MD University of Arkansas for Medical Sciences Kristin Hitchcock, MSI Department of Orthopedics AAOS Medical Librarian 4301 W Markham, #531 Little Rock, AR 72205 Special Acknowledgements Sara Anderson MPH John Segreti, MD Kevin Boyer Rush University Medical Center Laura Raymond, MA 600 S Paulina St. Ste 143 Chicago, Il 60612 Mark Spangehl, MD Mayo Clinic 5777 East Mayo Blvd Phoenix, AZ 85054 ix AAOS Clinical Practice Guidelines Unit v1.0 062110 Peer Review Participation in the AAOS peer review process does not constitute an endorsement of this guideline by the participating organization. The following organizations participated in peer review of this clinical practice guideline and gave explicit consent to be listed in this document: American Association of Hip and Knee Surgeons European Bone and Joint Infection Society Knee Society Musculoskeletal Infection Society Society of Nuclear Medicine Participation in the AAOS peer review process does not constitute an endorsement of this guideline by the participating organization. x AAOS Clinical Practice Guidelines Unit v1.0 062110
Description: