Prosthetic Joint InfectionNCT05060952
Calprotectin in Chronic Prosthetic Joint Infection
An observational study of Prosthetic Joint Infection and Prosthetic Infection, run by Technical University of Munich at 1 site in Germany.
Trial summary
A bacterial infection of an artificial joint is a serious complication that often requires additional surgery to exchange the arthroplasty. It is also difficult to recognize an infected joint, as the symptoms caused by the infection are very similar to those of other problems with arthroplasties, such as loosening of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prosthetic Joint Infection, Prosthetic Infection, Arthroplasty Complications
- What is being tested?
- Calprotectin Lateral Flow Test
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2019to 31 Dec 2025
- Phase
- Observational
- 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
Study population: Patients with painful or failed arthroplasty of the hip or knee joint scheduled for partial or complete arthroplasty exchange.
Who may be able to join
- scheduled arthroplasty exchange for any of the following reasons:
- infection
- loosening
- instability
- malalignment
- periprosthetic fracture
Who cannot join
- acute prosthetic joint infection
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Orthopedics and Sports Orthopedics, Klinikum rechts der Isar, Technical University Munich
Munich, Bavaria, 81675
Christian Suren, M.D., +49 89 4140 ext. 2271, christian.suren@tum.de
About this study
Official title: Synovial Fluid Calprotectin Lateral Flow Test for the Diagnosis of Prosthetic Joint Infection
A bacterial infection of an artificial joint is a serious complication that often requires additional surgery to exchange the arthroplasty. It is also difficult to recognize an infected joint, as the symptoms caused by the infection are very similar to those of other problems with arthroplasties, such as loosening of the implant. To improve the ability to diagnose prosthetic joint infections, this study compares the levels of calprotectin, a specific inflammatory protein, in the joint fluid of infected joints and joints with other complications. The underlying hypothesis is that the level of calprotectin in infected joints is significantly higher, thus facilitating the diagnosis of prosthetic joint infection.
- Being tested
- Calprotectin Lateral Flow Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calprotectin Lateral Flow TestDiagnostic test
Semiquantitative point of care photometric assay for the calprotectin level in joint fluid aspirate
| Study group | Role | What they receive |
|---|---|---|
| PJI | Patients with septic arthroplasty failure Receives: Diagnostic Test: Calprotectin Lateral Flow Test | |
| Aseptic | Patients with aseptic causes of arthroplasty failure Receives: Diagnostic Test: Calprotectin Lateral Flow Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of synovial fluid calprotectin
The level of synovial fluid calprotectin measured in joint fluid aspirate as a diagnostic test for prosthetic joint infection. The accuracy is calculated by comparing its results with the International Consensus Meeting (ICM) on prosthetic joint infection criteria of 2018.
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start1 Mar 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic Joint InfectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Suren, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060952
- Sponsor's protocol ID
- 26/19 S-SR
- Status last verified
- Sep 2021
- First submitted
- 19 Sep 2021
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synovial Fluid Calprotectin Lateral Flow Test for the Diagnosis of Prosthetic Joint Infection
- ClinicalTrials.gov ID
- NCT05060952
- Acronym / sponsor ID
- 26/19 S-SR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Sep 2021 (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.
A bacterial infection of an artificial joint is a serious complication that often requires additional surgery to exchange the arthroplasty. It is also difficult to recognize an infected joint, as the symptoms caused by the infection are very similar to those of other problems with arthroplasties, such as loosening of the implant. To improve the ability to diagnose prosthetic joint infections, this study compares the levels of calprotectin, a specific inflammatory protein, in the joint fluid of infected joints and joints with other complications. The underlying hypothesis is that the level of calprotectin in infected joints is significantly higher, thus facilitating the diagnosis of prosthetic joint infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PJI | – | Diagnostic Test: Calprotectin Lateral Flow TestPatients with septic arthroplasty failure |
| Aseptic | – | Diagnostic Test: Calprotectin Lateral Flow TestPatients with aseptic causes of arthroplasty failure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with painful or failed arthroplasty of the hip or knee joint scheduled for partial or complete arthroplasty exchange.
Key inclusion criteria (6 listed)
- scheduled arthroplasty exchange for any of the following reasons:
- infection
- loosening
- instability
- malalignment
Key exclusion criteria (1 listed)
- acute prosthetic joint 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 |
|---|---|---|
| Calprotectin Lateral Flow TestSemiquantitative point of care photometric assay for the calprotectin level in joint fluid aspirate | Diagnostic test | Aseptic, PJI |
Primary outcome
Diagnostic accuracy of synovial fluid calprotectin
Time frame: Intraoperatively
The level of synovial fluid calprotectin measured in joint fluid aspirate as a diagnostic test for prosthetic joint infection. The accuracy is calculated by comparing its results with the International Consensus Meeting (ICM) on prosthetic joint infection criteria of 2018.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Individual participant dataSharing planned: No
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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?
An observational study of Prosthetic Joint Infection and Prosthetic Infection, run by Technical University of Munich at 1 site in Germany.
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 6 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 29 Sep 2021. 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 Germany. 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 Christian Suren, M.D. (+49 89 4140 ext. 2271, christian.suren@tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of synovial fluid calprotectin (time frame: Intraoperatively). 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 29 Sep 2021.