PRO-DIAG: Improved Diagnosis of Prosthetic Joint Infections

A

Aalborg University

Status

Unknown

Conditions

Prosthesis-Related Infections

Treatments

Procedure: revision surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT03444571
PRO-DIAG
27751 (Other Grant/Funding Number)

Details and patient eligibility

About

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. .

Enrollment

40 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

40 participants in 2 patient groups

Control
No Intervention group
DNA based diagnosis
Experimental group
Treatment:
Procedure: revision surgery

Trial contacts and locations

1

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Central trial contact

Yijuan Xu, PhD

Data sourced from clinicaltrials.gov

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