PRO-DIAG: Improved Diagnosis of Prosthetic Joint Infections
PRO-DIAG
2 other identifiers
interventional
40
1 country
1
Brief Summary
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. .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 16, 2018
CompletedFirst Submitted
Initial submission to the registry
February 19, 2018
CompletedFirst Posted
Study publicly available on registry
February 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedFebruary 23, 2018
February 1, 2018
1.2 years
February 19, 2018
February 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Improved diagnostic accuracy
DNA based method can detect patients with hidden chronic infections more often than culture
6 months post surgery
Study Arms (2)
Control
NO INTERVENTIONDNA based diagnosis
EXPERIMENTALInterventions
If DNA based diagnosis detects infection, standard revision surgery will be conducted
Eligibility Criteria
You may qualify if:
- revision of hip platelets (THA) or knee replacement (TKA) on indication of likely infection
You may not qualify if:
- surgery within the last 4 months. The same applies to patients with short history of illness, pronounced acute symptoms and systemic response (reducing the likelihood of biofilm infection).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aalborg Universitylead
- Aalborg University Hospitalcollaborator
Study Sites (1)
Orthopedic surgery
Aalborg, Northern Jutland, 9000, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Post Doc
Study Record Dates
First Submitted
February 19, 2018
First Posted
February 23, 2018
Study Start
February 16, 2018
Primary Completion
May 1, 2019
Study Completion
December 1, 2019
Last Updated
February 23, 2018
Record last verified: 2018-02