Prosthesis-Related InfectionsPRO-DIAGNCT03444571
PRO-DIAG: Improved Diagnosis of Prosthetic Joint Infections
A study testing revision surgery in people with Prosthesis-Related Infections, run by Aalborg University at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prosthesis-Related Infections
- What is being tested?
- revision surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Feb 2018to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- revision of hip platelets (THA) or knee replacement (TKA) on indication of likely infection
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Orthopedic surgery
Aalborg, Northern Jutland, 9000
Thomas Jakobsen, PhD, 004597660000, thomas.jakobsen@rn.dk
About this study
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.
Read more
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. .
- Conditions
- Prosthesis-Related Infections
- Being tested
- revision surgery
- Medical subject headings
- Prosthesis-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
revision surgeryProcedure or surgery
If DNA based diagnosis detects infection, standard revision surgery will be conducted
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| DNA based diagnosis | Experimental | Not described Receives: Procedure: revision surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved diagnostic accuracy
DNA based method can detect patients with hidden chronic infections more often than culture
Measured: 6 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start16 Feb 2018
- Primary completionMay 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis-Related InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital
- Responsible party
- Principal investigator, Yijuan Xu, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444571
- Sponsor's protocol ID
- PRO-DIAG
- Other IDs
- 27751
- Acronym
- PRO-DIAG
- Status last verified
- Feb 2018
- First submitted
- 19 Feb 2018
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRO-DIAG: Improved Diagnosis of Prosthetic Joint Infections
- ClinicalTrials.gov ID
- NCT03444571
- Acronym / sponsor ID
- PRO-DIAG / PRO-DIAG
- Conditions
- Prosthesis-Related Infections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- Aalborg University Hospital
- Study start
- 16 Feb 2018 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 23 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| DNA based diagnosis | Experimental | Procedure: revision surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- revision of hip platelets (THA) or knee replacement (TKA) on indication of likely infection
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| revision surgeryIf DNA based diagnosis detects infection, standard revision surgery will be conducted | Procedure or surgery | DNA based diagnosis |
Primary outcome
Improved diagnostic accuracy
Time frame: 6 months post surgery
DNA based method can detect patients with hidden chronic infections more often than culture
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing revision surgery in people with Prosthesis-Related Infections, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yijuan Xu, PhD (004572201845, xuyijuan@bio.aau.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved diagnostic accuracy (time frame: 6 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018; AzTrials last refreshed its copy on 7 Nov 2026.