Septic Arthritis Clinical Trial
Official title:
Early Diagnostics of Septic Arthritis and Periprosthetic Joint Infections With Calorimetry and Polymerase Chain Reaction (PCR) of Synovial Aspirate Fluid
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.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | November 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Germany | Charité University Berlin | Berlin |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany | Berlin Institute of Health (BIH) |
Germany,
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. Review. — View Citation
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. — View Citation
Yusuf E, Hügle 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. — View Citation
Zimmerli W, Trampuz A, Ochsner PE. Prosthetic-joint infections. N Engl J Med. 2004 Oct 14;351(16):1645-54. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | growth of microbial agent in culture of joint aspirate | 14 days | No |
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