Arthrocentesis Study

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02530229
• Other study ID #: EA1/306/14
• Status: Recruiting
• Phase: N/A
• First received: August 19, 2015
• Last updated: August 20, 2015
• Start date: November 2014
• Est. completion date: November 2016

Study information

• Verified date: August 2015
• Source: Charite University, Berlin, Germany
• Contact: Christian Morgenstern, MD, PhD
• Phone: +4930450652206
• Email: christian.morgenstern[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Infectious
• Infection
• Periprosthetic Joint Infection
• Septic Arthritis

Locations

Country	Name	City	State
Germany	Charité University Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Berlin Institute of Health (BIH)

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	growth of microbial agent in culture of joint aspirate		14 days	No