PRO-DIAG: Improved Diagnosis of Prosthetic Joint Infections
NCT ID: NCT03444571
Last Updated: 2018-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2018-02-16
2019-12-31
Brief Summary
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Unfortunately, 5% of patients experience significant discomforts and complications. The second most frequent and serious complication is infection. While the established laboratory analyses (culture of tissue biopsies) are good at diagnosing acute infections, they are not satisfactory to diagnose a large group of patients especially with chronic infections. This can lead to prolonged diagnosing time and even to wrong diagnosis.
Several studies have shown that analyses of prosthetic parts and the use of molecular biological methods for detecting infecting microorganisms can significantly improve diagnostics accuracy.
The purpose of this project is primarily to demonstrate that analyses of bacterial specific DNA (16S rRNA genes) can confirm or rule out infection as fast (or faster) as cultivation methods. Rapid clarification can promote targeted treatment and in order to demonstrate this, the trial is conducted as a randomized study. .
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
TRIPLE
Study Groups
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Control
No interventions assigned to this group
DNA based diagnosis
revision surgery
If DNA based diagnosis detects infection, standard revision surgery will be conducted
Interventions
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revision surgery
If DNA based diagnosis detects infection, standard revision surgery will be conducted
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Aalborg University Hospital
OTHER
Aalborg University
OTHER
Responsible Party
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Yijuan Xu
Post Doc
Locations
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Orthopedic surgery
Aalborg, Northern Jutland, Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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27751
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
PRO-DIAG
Identifier Type: -
Identifier Source: org_study_id
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