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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
|Condition or disease|
|Periprosthetic Joint Infection Septic Arthritis|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||400 participants|
|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|
Periprosthetic joint infection
Patients with suspected periprosthetic joint infection of the hip, knee and shoulder
Patients with suspected septic arthritis of a native joint of the hip, knee and shoulder
- growth of microbial agent in culture of joint aspirate [ Time Frame: 14 days ]
Biospecimen Retention: Samples With DNA
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
|Contact: Christian Morgenstern, MD, PhDemail@example.com|
|Contact: Maren Engel, Study firstname.lastname@example.org|
|Charité University Berlin||Recruiting|
|Berlin, Germany, 17110|
|Contact: Andrej Trampuz, MD +4930450615073 email@example.com|
|Principal Investigator: Andrej Trampuz, MD|
|Sub-Investigator: Christian Morgenstern, MD,PhD|
|Principal Investigator:||Andrej Trampuz, MD||Charité University Berlin|