Prosthesis-Related Infections Clinical Trial
Official title:
PRO-DIAG: Improved Diagnosis of Prosthetic Joint Infections
Implantation of joint prostheses is currently the second largest diagnosis-related group in
the Danish health service, and in view of the demographic development and spread of lifestyle
diseases, this type of intervention is expected to continue to increase.
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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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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| Completed |
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| Completed |
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| Completed |
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| Completed |
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| Completed |
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Phase 4 | |
| Recruiting |
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Phase 4 |