PRO-DIAG: Improved Diagnosis of Prosthetic Joint Infections

Prosthesis-Related Infections Clinical Trial

— PRO-DIAG  

Official title:

PRO-DIAG: Improved Diagnosis of Prosthetic Joint Infections

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03444571
• Other study ID #: PRO-DIAG
• Secondary ID: 27751
• Status: Recruiting
• Phase: N/A
• First received: February 19, 2018
• Last updated: February 19, 2018
• Start date: February 16, 2018
• Est. completion date: December 2019

Study information

• Verified date: February 2018
• Source: Aalborg University
• Contact: Yijuan Xu, PhD
• Phone: 004572201845
• Email: xuyijuan[@]bio.aau.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Prosthesis-Related Infections

Intervention

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

Locations

Country	Name	City	State
Denmark	Orthopedic surgery	Aalborg	Northern Jutland

Sponsors (2)

Lead Sponsor	Collaborator
Aalborg University	Aalborg Universitetshospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved diagnostic accuracy	DNA based method can detect patients with hidden chronic infections more often than culture	6 months post surgery