- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02530229
Arthrocentesis Study
Early Diagnostics of Septic Arthritis and Periprosthetic Joint Infections With Calorimetry and Polymerase Chain Reaction (PCR) of Synovial Aspirate Fluid
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
In this study, joint aspirate of patients that undergo joint aspiration in the context of routine pre- and intra-operative clinical diagnosis of a hip, knee or shoulder joint is collected. Routine joint punctures at our clinic are regularly performed in the emergency room, in the outpatient clinic and intra-operatively during diagnostic and revision surgery. A minimum of 5 ml aspiration fluid was required for inclusion in this study. Empty or diluted aspirations were excluded.
Joint aspirations are performed by orthopaedic surgeons with an 18-gauge needle according to standardized aseptic technique. Intraoperative punctures are performed prior to arthrotomy. A minimum of 1ml of joint aspirate is immediately transferred to a native study vial for our study, a native vial for gram stain and culture and a native vial for polarization microscopy, respectively. A minimum of 1 ml joint aspirate is transferred to an ethylenediaminetetraacetic acid (EDTA) vial for the determination of leucocyte count. Finally, a minimum of 1 ml is inoculated into a paediatric blood culture bottle.
Standard microbiological methods are performed in an external laboratory that routinely collaborates with our clinic. Leucocyte count is performed automatically with the mentioned EDTA vial. Polarization microscopy is performed at our pathohistological department in order to detect crystals and signs of infection in joint aspirate.
If written informational consent has been signed by the patient, the study vial is immediately transported to our internal laboratory for analysis with new diagnostic methods (microcalorimetry, PCR, etc.). When an immediate transportation was not feasible, the vial is stored in a cooling fridge at +3° C until transportation was possible.
Each case is individually reviewed and classified by an experienced infectiologist taking the case's clinical history and laboratory results into account.
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienkontakt
- Name: Christian Morgenstern, MD, PhD
- Telefonnummer: +4930450652206
- E-Mail: christian.morgenstern@charite.de
Studieren Sie die Kontaktsicherung
- Name: Maren Engel, Study nurse
- Telefonnummer: +4930450652416
- E-Mail: maren.engel@charite.de
Studienorte
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Berlin, Deutschland, 17110
- Rekrutierung
- Charite University Berlin
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Kontakt:
- Andrej Trampuz, MD
- Telefonnummer: +4930450615073
- E-Mail: andrej.trampuz@charite.de
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Hauptermittler:
- Andrej Trampuz, MD
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Unterermittler:
- Christian Morgenstern, MD,PhD
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- adult of 18 or more years
- written consent to participate in study
- suspicion of septic arthritis or periprosthetic joint infection
- joint aspirate minimum of 5 ml
Exclusion Criteria:
- is not able to understand the aim or purpose of this study
- empty joint aspirate
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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Periprosthetic joint infection
Patients with suspected periprosthetic joint infection of the hip, knee and shoulder
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Septic arthritis
Patients with suspected septic arthritis of a native joint of the hip, knee and shoulder
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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growth of microbial agent in culture of joint aspirate
Zeitfenster: 14 days
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14 days
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Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Andrej Trampuz, MD, Charite University Berlin
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Zimmerli W, Trampuz A, Ochsner PE. Prosthetic-joint infections. N Engl J Med. 2004 Oct 14;351(16):1645-54. doi: 10.1056/NEJMra040181. No abstract available.
- Trampuz A, Hanssen AD, Osmon DR, Mandrekar J, Steckelberg JM, Patel R. Synovial fluid leukocyte count and differential for the diagnosis of prosthetic knee infection. Am J Med. 2004 Oct 15;117(8):556-62. doi: 10.1016/j.amjmed.2004.06.022.
- Yusuf E, Hugle T, Daikeler T, Voide C, Borens O, Trampuz A. The potential use of microcalorimetry in rapid differentiation between septic arthritis and other causes of arthritis. Eur J Clin Microbiol Infect Dis. 2015 Mar;34(3):461-5. doi: 10.1007/s10096-014-2248-y. Epub 2014 Sep 25.
- Corvec S, Portillo ME, Pasticci BM, Borens O, Trampuz A. Epidemiology and new developments in the diagnosis of prosthetic joint infection. Int J Artif Organs. 2012 Oct;35(10):923-34. doi: 10.5301/ijao.5000168.
- Karbysheva S, Cabric S, Koliszak A, Bervar M, Kirschbaum S, Hardt S, Perka C, Trampuz A. Clinical evaluation of dithiothreitol in comparison with sonication for biofilm dislodgement in the microbiological diagnosis of periprosthetic joint infection. Diagn Microbiol Infect Dis. 2022 Jun;103(2):115679. doi: 10.1016/j.diagmicrobio.2022.115679. Epub 2022 Mar 12.
- Morgenstern C, Renz N, Cabric S, Maiolo E, Perka C, Trampuz A. Thermogenic diagnosis of periprosthetic joint infection by microcalorimetry of synovial fluid. BMC Musculoskelet Disord. 2020 Jun 3;21(1):345. doi: 10.1186/s12891-020-03366-3.
- Sigmund IK, Renz N, Feihl S, Morgenstern C, Cabric S, Trampuz A. Value of multiplex PCR for detection of antimicrobial resistance in samples retrieved from patients with orthopaedic infections. BMC Microbiol. 2020 Apr 14;20(1):88. doi: 10.1186/s12866-020-01741-7.
- Morgenstern C, Renz N, Cabric S, Perka C, Trampuz A. Multiplex Polymerase Chain Reaction and Microcalorimetry in Synovial Fluid: Can Pathogen-based Detection Assays Improve the Diagnosis of Septic Arthritis? J Rheumatol. 2018 Nov;45(11):1588-1593. doi: 10.3899/jrheum.180311. Epub 2018 Sep 15.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- EA1/306/14
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