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Positive Alpha-defensin at Reimplantation of a Two-stage Revision Arthroplasty Is Not Associated with Infection at 1 Year

Samuel, Linsen T. MD, MBA; Sultan, Assem A. MD; Kheir, Matthew MD; Villa, Jesus MD; Patel, Preetesh MD; Parvizi, Javad MD; Higuera, Carlos A. MD

Clinical Orthopaedics and Related Research®: July 2019 - Volume 477 - Issue 7 - p 1615–1621
doi: 10.1097/CORR.0000000000000620
2018 MUSCULOSKELETAL INFECTION SOCIETY PROCEEDINGS
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Background Diagnosing periprosthetic joint infection (PJI) represents a challenge that relies on multiple clinical and laboratory criteria that may not be consistently present. The synovial alpha-defensin-1 (AD-1) test has been shown to correlate accurately with the Musculoskeletal Infection Society (MSIS) criteria for the diagnosis of PJI, however, its association with persistent PJI has not been elucidated in the setting of patients receiving antibiotic spacers during second-stage reimplantation. Applying a Delphi-based consensus to define successful eradication of PJI offers an opportunity to test the utility of AD-1 in this setting.

Questions/purposes (1) Can the AD-1 test determine whether infection has been controlled using the Delphi criteria for persistent PJI as a surrogate for infection eradication during two-stage revision for PJI treatment with a spacer? (2) How does the performance of the AD-1 test compare with the MSIS criteria?

Methods This was a multicenter analysis of retrospectively collected data on patients who underwent a two-stage revision arthroplasty between May 2014 and July 2016. We included patients who had a previously confirmed PJI and received a cement spacer, underwent the second stage, had MSIS criteria data and a synovial fluid AD-1 test, and had a minimum followup of 1 year. We were unable to determine for all study sites how many patients had the test but did not meet all the criteria and so could not be studied; however, we were able to identify 69 patients (43 knees, 26 hips) who met all criteria. During the period in question, indications for use of AD-1 varied by surgeon; however, during that time, in general if a surgeon ordered it as part of the initial workup, the test would have been repeated before the second-stage reimplantation procedure. To assess the validity of AD-1 against persistence of PJI criteria at 1 year, the following were calculated using the Delphi criteria for persistent PJI as the gold standard: sensitivity, specificity, positive and negative predictive values, accuracy, and area under the curve (AUC) with 95% confidence intervals (CIs). Concordance index (c-index) and its Wald 95% CI with receiver operating characteristic (ROC) curve were calculated in relation to Delphi criteria for persistent PJI using AD-1 and then MSIS criteria. The two c-indices of AD-1 and MSIS were compared using the DeLong nonparametric approach.

Results The AD-1 test showed poor sensitivity (7%; 95% CI, 0.2–34), and poor overall accuracy (73%; 95% CI, 60–83; AUC = 0.5; 95% CI, 0.3–0.6) in detecting infection eradication at 1 year. The c-index for AD-1 versus Delphi criteria for persistent PJI was 0.519 (95% CI, 0.44–0.60), and the c-index for MSIS criteria versus Delphi criteria for persistent PJI was 0.518 (95% CI, 0.49–0.54), suggesting the weak diagnostic abilities of these models. The contrast estimate between MSIS criteria and AD-1 were not different from one another at -0.001 (95% CI%, -0.09 to 0.09; p = 0.99).

Conclusions We found that a positive synovial fluid AD-1 test correlated poorly with the presence of persistent infection 1 year after two-stage revision arthroplasty for PJI. For this reason, we recommend against the routine use of AD-1 in patients with cement spacers, until or unless future studies demonstrate that the test is more effective than we found it to be.

Level of Evidence Level IV, diagnostic study.

L. T. Samuel, A. A. Sultan, Department of Orthopaedic Surgery, Cleveland Clinic, Cleveland, Ohio, USA

M. Kheir, J. Parvizi, Department of Orthopaedic Surgery, The Rothman Institute, Philadelphia, PA, USA

J. Villa, P. Patel, C. A. Higuera, Department of Orthopaedic Surgery, Cleveland Clinic, Weston, FL, USA

L. T. Samuel, Department of Orthopaedic Surgery, 9500 Euclid Ave, A40, Cleveland, Ohio, 44195 USA, Email: samuell@ccf.org

One of the authors certifies that he (CAH), or a member of his immediate family, has received or may receive payments or benefits, during the study period, an amount of less than USD 10,000 from KCI (San Antonio, TX, USA); an amount of less than USD 10,000 from Zimmer Biomet (Warsaw, IN, USA); an amount of less than USD 10,000 from Covance (Princeton, NJ, USA); an amount of less than USD 10,000 from Pfizer (New York, NY, USA); an amount of less than USD 10,000 from TenNor Therapeutics Limited (Suzhou Industrial Park, China); and has received research support funding from Stryker (Kalamazoo, MI, USA), Myoscience (Fresno, CA, USA), CD Diagnostics (Claymont, DE, USA), KCI (San Antonio, TX, USA), OREF (Rosemont, IL, USA), Pacira (Parsippany, NJ, USA), 3M (Maplewood, MN, USA), Cymedica (Scottsdale, AZ, USA), Ferring Pharmaceuticals (Parsippany, NJ, USA), and Orthofix, Inc. (Lewisville, TX, USA), outside of this work.

One of the authors certifies that he (JP), or a member of his immediate family, has received or may receive payments or benefits, during the study period, an amount of USD 10,000 to USD 100,000 from Zimmer Biomet (Warsaw, IN, USA); an amount of less than USD 10,000 from ConvaTec (Skillman, NJ, USA); an amount of USD 10,000 from TissueGene (Rockville, MD, USA); an amount of less than USD 10,000 from CeramTec (Plochingen, Germany); and an amount of less than USD 10,000 from Ethicon (Somerville, NJ, USA), and has stock options with Parvizi Surgical Innovations (Philadelphia, PA, USA); Hip Innovation Technology (Plantation, FL, USA); CD Diagnostics (Wynnewood, PA, USA); CorenTec (Seoul, Korea); Alphaeon (Irvine, CA, USA); Joint Purification Systems (Solana Beach, CA, USA); Ceribell (Mountain View, CA, USA); MedAP (Cape Town, South Africa); Cross Current Business Intelligence (Doylestown, PA, USA); Invisible Sentinel (Philadelphia, PA, USA); Physician Recommended Nutriceuticals (Plymouth Meeting, PA, USA); Intellijoint (Waterloo, Ontario, Canada); and MicroGenDx (Tallahassee, FL, USA).He has received royalties in the amount of less than USD 10,000 from Corentec (Seoul, Korea); an amount of less than USD 10,000 from Datatrace (Houston, TX, USA); an amount of less than USD 10,000 from Elsevier (Philadelphia, PA, USA); an amount of less than USD 10,000 from Wolters-Kluwer (Philadelphia, PA, USA); an amount of less than USD 10,000 from Slack Inc (Thorofare, NJ, USA); and an amount of less than USD 10,000 from Jaypee (New Delhi, India); has a board membership with the Journal of Arthroplasty; Journal of Bone and Joint Surgery; Bone and Joint Journal; Eastern Orthopaedic Association (Towson, MD, USA); Muller Foundation (Baltimore, MD, USA); and United Healthcare (Hopkins, MN, USA).

One of the authors certifies that he (PP), or a member of his or her immediate family, has received or may receive payments or benefits, during the study period, an amount of less than USD 10,000 from Stryker (Kalamazoo, MI, USA).

All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request.

Clinical Orthopaedics and Related Research® neither advocates nor endorses the use of any treatment, drug, or device. Readers are encouraged to always seek additional information, including FDA approval status, of any drug or device before clinical use.

Each author certifies that his institution approved the human protocol for this investigation and that all investigations were conducted in conformity with ethical principles of research.

This work was performed at the Cleveland Clinic, Cleveland, Ohio, USA.

Received September 01, 2018

Accepted December 04, 2018

© 2019 Lippincott Williams & Wilkins LWW
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