Diagnosis Prosthetic Joint InfectionSyPJINCT03038464
Synovial Aspiration and Serological Testing in Two-stage Revision Arthroplasty of Prosthetic Joint Infection
An observational study of Diagnosis Prosthetic Joint Infection, run by Technical University of Munich at 1 site in Germany.
Trial summary
The two-stage protocol is gold standard in terms of infection control treating prosthetic joint infections of total hip and total knee arthroplasty. The antibiotic pause for diagnostic reasons before reconstruction (stage two) is discussed concerning persistence of infection and development of resistant bacterial… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diagnosis Prosthetic Joint Infection
- What is being tested?
- Synovial biopsy
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2016to 1 May 2019
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with periprostheitc joint infection
Who may be able to join
- Patients with periprostheitc joint infection
Who cannot join
- Reinfection in history
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinikum rechts der Isar
Munich, Bavaria, 81675
Norbert Harrasser, DR., 00498941405229, norbert.harrasser@gmx.net
Ingo Banke, Dr., 00498941405284, ingo@banke.eu
About this study
Official title: Benefit of Synovial Aspiration and Serological Testing in Two-stage Revision Arthroplasty of Prosthetic Joint Infection
The two-stage protocol is gold standard in terms of infection control treating prosthetic joint infections of total hip and total knee arthroplasty. The antibiotic pause for diagnostic reasons before reconstruction (stage two) is discussed concerning persistence of infection and development of resistant bacterial strains. Serological markers and synovial analysis are common use to exclude persistence of infection.
The investigators therefore asked 1) is the serological testing of c-reactive protein and leukocytes a valuable tool to predict a persistence of infection and 2) what is the role of synovial aspiration of PMMA Spacers on hip and knee joints.
- Conditions
- Diagnosis Prosthetic Joint Infection
- Being tested
- Synovial biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synovial biopsyDiagnostic test
Biopsy of jint prior reimplantation of new joint prosthesis
What is being measured
The primary outcome is the main question the study is designed to answer.
Reinfection rate
Reinfection rate after reimplantation of joint prosthesis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start1 Nov 2016
- Primary completion1 Apr 2019 (estimated)
- Study completion1 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnosis Prosthetic Joint InfectionStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harrasser, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038464
- Sponsor's protocol ID
- 445/21
- Acronym
- SyPJI
- Status last verified
- Jan 2017
- First submitted
- 30 Jan 2017
- Last updated
- 25 Apr 2017
- 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 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Synovial Aspiration and Serological Testing in Two-stage Revision Arthroplasty of Prosthetic Joint Infection
- ClinicalTrials.gov ID
- NCT03038464
- Acronym / sponsor ID
- SyPJI / 445/21
- Conditions
- Diagnosis Prosthetic Joint Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 1 May 2019 (estimated)
- First posted
- 31 Jan 2017 (estimated)
- 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.
The two-stage protocol is gold standard in terms of infection control treating prosthetic joint infections of total hip and total knee arthroplasty. The antibiotic pause for diagnostic reasons before reconstruction (stage two) is discussed concerning persistence of infection and development of resistant bacterial strains. Serological markers and synovial analysis are common use to exclude persistence of infection.
The investigators therefore asked 1) is the serological testing of c-reactive protein and leukocytes a valuable tool to predict a persistence of infection and 2) what is the role of synovial aspiration of PMMA Spacers on hip and knee joints.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with periprostheitc joint infection
Key inclusion criteria (1 listed)
- Patients with periprostheitc joint infection
Key exclusion criteria (1 listed)
- Reinfection in history
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 |
|---|---|---|
| Synovial biopsyBiopsy of jint prior reimplantation of new joint prosthesis | Diagnostic test | – |
Primary outcome
Reinfection rate
Time frame: 2 years
Reinfection rate after reimplantation of joint prosthesis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Diagnosis Prosthetic Joint Infection
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Enrolling by invitationPhase 4
Probiotics in the Prevention of Recurrent Prosthetic Joint Infection of the Hip and Knee
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RecruitingPhase 2
Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement.
Arthroplasty, Replacement, Hip, Osteoarthritis, Hip
Enrolling by invitationPhase 4
Antibiotic Prophylaxis in High-Risk Arthroplasty Patients
Infections Joint Prosthetic, Overweight or Obesity
RecruitingObservational study
Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Revision Hip Prosthesis System
Revision Hip Arthroplasty, Aseptic Loosening of Prosthetic Joint
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 Diagnosis Prosthetic Joint 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 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 25 Apr 2017. 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 norbert harrasser (15232716657, norbert.harrasser@gmx.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reinfection rate (time frame: 2 years). 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 25 Apr 2017.