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Arthrocentesis Study

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ClinicalTrials.gov Identifier: NCT02530229
Recruitment Status : Unknown
Verified August 2015 by Andrej Trampuz, Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
First Posted : August 21, 2015
Last Update Posted : August 21, 2015
Sponsor:
Collaborator:
Berlin Institute of Health
Information provided by (Responsible Party):
Andrej Trampuz, Charite University, Berlin, Germany

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.

Condition or disease
Periprosthetic Joint Infection Septic Arthritis

Detailed 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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Early Diagnostics of Septic Arthritis and Periprosthetic Joint Infections With Calorimetry and Polymerase Chain Reaction (PCR) of Synovial Aspirate Fluid
Study Start Date : November 2014
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. growth of microbial agent in culture of joint aspirate [ Time Frame: 14 days ]

Biospecimen Retention:   Samples With DNA
joint aspirates of native joints and joints with suspected periprosthetic joint infection


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02530229


Contacts
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Contact: Christian Morgenstern, MD, PhD +4930450652206 christian.morgenstern@charite.de
Contact: Maren Engel, Study nurse +4930450652416 maren.engel@charite.de

Locations
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Germany
Charité University Berlin Recruiting
Berlin, Germany, 17110
Contact: Andrej Trampuz, MD    +4930450615073    andrej.trampuz@charite.de   
Principal Investigator: Andrej Trampuz, MD         
Sub-Investigator: Christian Morgenstern, MD,PhD         
Sponsors and Collaborators
Charite University, Berlin, Germany
Berlin Institute of Health
Investigators
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Principal Investigator: Andrej Trampuz, MD Charité University Berlin

Additional Information:

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Andrej Trampuz, Head Septic Surgery Unit, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02530229     History of Changes
Other Study ID Numbers: EA1/306/14
First Posted: August 21, 2015    Key Record Dates
Last Update Posted: August 21, 2015
Last Verified: August 2015
Keywords provided by Andrej Trampuz, Charite University, Berlin, Germany:
periprosthetic joint infection
septic arthritis
Additional relevant MeSH terms:
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Infection
Arthritis, Infectious
Arthritis
Joint Diseases
Musculoskeletal Diseases