An interventional study of revision surgery in Prosthesis-Related Infections, sponsored by Aalborg University. Status unknown at 1 site in Denmark. Per ClinicalTrials.gov, last updated 2018-02-23.
Sponsored by Aalborg University · Not applicable, Interventional, and Diagnostic
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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. .
35 studies on the registry are indexed under Prosthesis-Related Infections; 10 are open to participants now.
This study's planned enrollment of 40 is below the median of 193 across 20 interventional studies indexed under Prosthesis-Related Infections.
Browse Prosthesis-Related Infections studies →Aalborg University is the lead sponsor of 183 studies on the registry; 32 are open to participants now.
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Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: revision surgery
If DNA based diagnosis detects infection, standard revision surgery will be conducted
Improved diagnostic accuracy
DNA based method can detect patients with hidden chronic infections more often than culture
Time frame: 6 months post surgery
Plan to share: Undecided
No publications or documents are linked to this record.
Started Feb 2018 (actual). Primary completion is estimated for May 2019, 15 months after the start.
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This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Prosthesis-Related Infections →