Arthrocentesis Study
Early Diagnostics of Septic Arthritis and Periprosthetic Joint Infections With Calorimetry and Polymerase Chain Reaction (PCR) of Synovial Aspirate Fluid
1 other identifier
observational
400
1 country
1
Brief Summary
The purpose of this study is to analyze pre- and intra-operative joint aspirates of native joints and joints with suspicion of periprosthetic joint infection (PJI) of the hip, knee and shoulder acquired in clinical routine. Joint aspirates are then analyzed with new diagnostic methods (microcalorimetry, PCR, alpha-defensin, etc.). Diagnostic speed and accuracy of these methods is compared to standard diagnostic methods in clinical routine, such as blood cultures of joint aspirates, cell count/differential, intra-operative tissue culture and histology and sonication.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 19, 2015
CompletedFirst Posted
Study publicly available on registry
August 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedAugust 21, 2015
August 1, 2015
2 years
August 19, 2015
August 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
growth of microbial agent in culture of joint aspirate
14 days
Study Arms (2)
Periprosthetic joint infection
Patients with suspected periprosthetic joint infection of the hip, knee and shoulder
Septic arthritis
Patients with suspected septic arthritis of a native joint of the hip, knee and shoulder
Eligibility Criteria
Any patient with suspicion of septic arthritis or periprosthetic joint infection of the hip, knee and shoulder being diagnosed or treated in our facility in a clinical routine scenario willing to participate in this study (written informational consent)
You may qualify if:
- 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
You may not qualify if:
- is not able to understand the aim or purpose of this study
- empty joint aspirate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Charite University, Berlin, Germanylead
- Berlin Institute of Healthcollaborator
Study Sites (1)
Charité University Berlin
Berlin, State of Berlin, 17110, Germany
Related Publications (8)
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.
PMID: 25252631BACKGROUNDCorvec 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.
PMID: 23138706BACKGROUNDTrampuz 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.
PMID: 15465503BACKGROUNDZimmerli 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.
PMID: 15483283BACKGROUNDKarbysheva 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.
PMID: 35395437DERIVEDMorgenstern 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.
PMID: 32493292DERIVEDSigmund 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.
PMID: 32290833DERIVEDMorgenstern 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.
PMID: 30219763DERIVED
Biospecimen
joint aspirates of native joints and joints with suspected periprosthetic joint infection
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrej Trampuz, MD
Charité University Berlin
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head Septic Surgery Unit
Study Record Dates
First Submitted
August 19, 2015
First Posted
August 21, 2015
Study Start
November 1, 2014
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
August 21, 2015
Record last verified: 2015-08