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PRO-DIAG: Improved Diagnosis of Prosthetic Joint Infections

PRO-DIAG: Improved Diagnosis of Prosthetic Joint Infections

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03444571
Acronym
PRO-DIAG
Enrollment
40
Registered
2018-02-23
Start date
2018-02-16
Completion date
2019-12-31
Last updated
2018-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prosthesis-Related Infections

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. .

Interventions

If DNA based diagnosis detects infection, standard revision surgery will be conducted

Sponsors

Aalborg University Hospital
CollaboratorOTHER
Aalborg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* revision of hip platelets (THA) or knee replacement (TKA) on indication of likely infection

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
Improved diagnostic accuracy6 months post surgeryDNA based method can detect patients with hidden chronic infections more often than culture

Countries

Denmark

Contacts

Primary ContactYijuan Xu, PhD
xuyijuan@bio.aau.dk004572201845

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026