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PRO-DIAG: Improved Diagnosis of Prosthetic Joint Infections (PRO-DIAG)

Primary Purpose

Prosthesis-Related Infections

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
revision surgery
Sponsored by
Aalborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prosthesis-Related Infections

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Orthopedic surgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

DNA based diagnosis

Arm Description

Outcomes

Primary Outcome Measures

Improved diagnostic accuracy
DNA based method can detect patients with hidden chronic infections more often than culture

Secondary Outcome Measures

Full Information

First Posted
February 19, 2018
Last Updated
February 19, 2018
Sponsor
Aalborg University
Collaborators
Aalborg University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03444571
Brief Title
PRO-DIAG: Improved Diagnosis of Prosthetic Joint Infections
Acronym
PRO-DIAG
Official Title
PRO-DIAG: Improved Diagnosis of Prosthetic Joint Infections
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 16, 2018 (Actual)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University
Collaborators
Aalborg University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthesis-Related Infections

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
DNA based diagnosis
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
revision surgery
Intervention Description
If DNA based diagnosis detects infection, standard revision surgery will be conducted
Primary Outcome Measure Information:
Title
Improved diagnostic accuracy
Description
DNA based method can detect patients with hidden chronic infections more often than culture
Time Frame
6 months post surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yijuan Xu, PhD
Phone
004572201845
Email
xuyijuan@bio.aau.dk
Facility Information:
Facility Name
Orthopedic surgery
City
Aalborg
State/Province
Northern Jutland
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Jakobsen, PhD
Phone
004597660000
Email
thomas.jakobsen@rn.dk

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

PRO-DIAG: Improved Diagnosis of Prosthetic Joint Infections

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