Periprosthetic Joint InfectionNCT02530229
Arthrocentesis Study
An observational study of Periprosthetic Joint Infection and Septic Arthritis, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The purpose of this study is to analyze pre- and intra-operative joint aspirates of native joints and joints with suspicion of periprosthetic joint infection (PJI) of the hip, knee and shoulder acquired in clinical routine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periprosthetic Joint Infection, Septic Arthritis
- How many people
- 400 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2014to Nov 2016
- How long will I take part?
- 3 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient with suspicion of septic arthritis or periprosthetic joint infection of the hip, knee and shoulder being diagnosed or treated in our facility in a clinical routine scenario willing to participate in this study (written informational consent)
Who may be able to join
- adult of 18 or more years
- written consent to participate in study
- suspicion of septic arthritis or periprosthetic joint infection
- joint aspirate minimum of 5 ml
Who cannot join
- is not able to understand the aim or purpose of this study
- empty joint aspirate
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charité University Berlin
Berlin, State of Berlin, 17110
Andrej Trampuz, MD, +4930450615073, andrej.trampuz@charite.de
Andrej Trampuz, MD
About this study
Official title: Early Diagnostics of Septic Arthritis and Periprosthetic Joint Infections With Calorimetry and Polymerase Chain Reaction (PCR) of Synovial Aspirate Fluid
The purpose of this study is to analyze pre- and intra-operative joint aspirates of native joints and joints with suspicion of periprosthetic joint infection (PJI) of the hip, knee and shoulder acquired in clinical routine. Joint aspirates are then analyzed with new diagnostic methods (microcalorimetry, PCR, alpha-defensin, etc.). Diagnostic speed and accuracy of these methods is compared to standard diagnostic methods in clinical routine, such as blood cultures of joint aspirates, cell count/differential, intra-operative tissue culture and histology and sonication.
Read the detailed description
In this study, joint aspirate of patients that undergo joint aspiration in the context of routine pre- and intra-operative clinical diagnosis of a hip, knee or shoulder joint is collected. Routine joint punctures at our clinic are regularly performed in the emergency room, in the outpatient clinic and intra-operatively during diagnostic and revision surgery. A minimum of 5 ml aspiration fluid was required for inclusion in this study. Empty or diluted aspirations were excluded.
Joint aspirations are performed by orthopaedic surgeons with an 18-gauge needle according to standardized aseptic technique. Intraoperative punctures are performed prior to arthrotomy. A minimum of 1ml of joint aspirate is immediately transferred to a native study vial for our study, a native vial for gram stain and culture and a native vial for polarization microscopy, respectively. A minimum of 1 ml joint aspirate is transferred to an ethylenediaminetetraacetic acid (EDTA) vial for the determination of leucocyte count. Finally, a minimum of 1 ml is inoculated into a paediatric blood culture bottle.
Standard microbiological methods are performed in an external laboratory that routinely collaborates with our clinic. Leucocyte count is performed automatically with the mentioned EDTA vial. Polarization microscopy is performed at our pathohistological department in order to detect crystals and signs of infection in joint aspirate.
If written informational consent has been signed by the patient, the study vial is immediately transported to our internal laboratory for analysis with new diagnostic methods (microcalorimetry, PCR, etc.). When an immediate transportation was not feasible, the vial is stored in a cooling fridge at +3° C until transportation was possible.
Each case is individually reviewed and classified by an experienced infectiologist taking the case's clinical history and laboratory results into account.
- Conditions
- Periprosthetic Joint Infection, Septic Arthritis
- Keywords
- periprosthetic joint infection, septic arthritis
- Medical subject headings
- Arthritis, Infectious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Periprosthetic joint infection | Patients with suspected periprosthetic joint infection of the hip, knee and shoulder | |
| Septic arthritis | Patients with suspected septic arthritis of a native joint of the hip, knee and shoulder |
What is being measured
The primary outcome is the main question the study is designed to answer.
growth of microbial agent in culture of joint aspirate
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2015 (estimated)
- Study startNov 2014
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Periprosthetic Joint InfectionStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Berlin Institute of Health
- Responsible party
- Principal investigator, Andrej Trampuz, Charite University, Berlin, Germany
- Investigators
- Andrej Trampuz, MD, Principal investigator, Charité University Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530229
- Sponsor's protocol ID
- EA1/306/14
- Status last verified
- Aug 2015
- First submitted
- 19 Aug 2015
- Last updated
- 21 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Yusuf E, Hugle T, Daikeler T, Voide C, Borens O, Trampuz A. The potential use of microcalorimetry in rapid differentiation between septic arthritis and other causes of arthritis. Eur J Clin Microbiol Infect Dis. 2015 Mar;34(3):461-5. doi: 10.1007/s10096-014-2248-y. Epub 2014 Sep 25.
PubMed 25252631Corvec S, Portillo ME, Pasticci BM, Borens O, Trampuz A. Epidemiology and new developments in the diagnosis of prosthetic joint infection. Int J Artif Organs. 2012 Oct;35(10):923-34. doi: 10.5301/ijao.5000168.
PubMed 23138706Trampuz A, Hanssen AD, Osmon DR, Mandrekar J, Steckelberg JM, Patel R. Synovial fluid leukocyte count and differential for the diagnosis of prosthetic knee infection. Am J Med. 2004 Oct 15;117(8):556-62. doi: 10.1016/j.amjmed.2004.06.022.
PubMed 15465503Zimmerli W, Trampuz A, Ochsner PE. Prosthetic-joint infections. N Engl J Med. 2004 Oct 14;351(16):1645-54. doi: 10.1056/NEJMra040181. No abstract available.
PubMed 15483283Lozano-Garcia M, Estrada-Petrocelli L, Roman RR, Jane R, Trampuz A, Morgenstern C. A Machine Learning Approach to Microcalorimetric Pattern Classification of Pathogens in Synovial Fluid. J Orthop Res. 2025 Oct;43(10):1855-1864. doi: 10.1002/jor.70024. Epub 2025 Jul 13.
PubMed 40652382Karbysheva S, Cabric S, Koliszak A, Bervar M, Kirschbaum S, Hardt S, Perka C, Trampuz A. Clinical evaluation of dithiothreitol in comparison with sonication for biofilm dislodgement in the microbiological diagnosis of periprosthetic joint infection. Diagn Microbiol Infect Dis. 2022 Jun;103(2):115679. doi: 10.1016/j.diagmicrobio.2022.115679. Epub 2022 Mar 12.
PubMed 35395437Morgenstern C, Renz N, Cabric S, Maiolo E, Perka C, Trampuz A. Thermogenic diagnosis of periprosthetic joint infection by microcalorimetry of synovial fluid. BMC Musculoskelet Disord. 2020 Jun 3;21(1):345. doi: 10.1186/s12891-020-03366-3.
PubMed 32493292Sigmund IK, Renz N, Feihl S, Morgenstern C, Cabric S, Trampuz A. Value of multiplex PCR for detection of antimicrobial resistance in samples retrieved from patients with orthopaedic infections. BMC Microbiol. 2020 Apr 14;20(1):88. doi: 10.1186/s12866-020-01741-7.
PubMed 32290833Morgenstern C, Renz N, Cabric S, Perka C, Trampuz A. Multiplex Polymerase Chain Reaction and Microcalorimetry in Synovial Fluid: Can Pathogen-based Detection Assays Improve the Diagnosis of Septic Arthritis? J Rheumatol. 2018 Nov;45(11):1588-1593. doi: 10.3899/jrheum.180311. Epub 2018 Sep 15.
PubMed 30219763
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnostics of Septic Arthritis and Periprosthetic Joint Infections With Calorimetry and Polymerase Chain Reaction (PCR) of Synovial Aspirate Fluid
- ClinicalTrials.gov ID
- NCT02530229
- Acronym / sponsor ID
- EA1/306/14
- Conditions
- Periprosthetic Joint Infection, Septic Arthritis
- Keywords
- periprosthetic joint infection, septic arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Berlin Institute of Health
- Study start
- Nov 2014
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 21 Aug 2015 (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 purpose of this study is to analyze pre- and intra-operative joint aspirates of native joints and joints with suspicion of periprosthetic joint infection (PJI) of the hip, knee and shoulder acquired in clinical routine. Joint aspirates are then analyzed with new diagnostic methods (microcalorimetry, PCR, alpha-defensin, etc.). Diagnostic speed and accuracy of these methods is compared to standard diagnostic methods in clinical routine, such as blood cultures of joint aspirates, cell count/differential, intra-operative tissue culture and histology and sonication.
Detailed description
In this study, joint aspirate of patients that undergo joint aspiration in the context of routine pre- and intra-operative clinical diagnosis of a hip, knee or shoulder joint is collected. Routine joint punctures at our clinic are regularly performed in the emergency room, in the outpatient clinic and intra-operatively during diagnostic and revision surgery. A minimum of 5 ml aspiration fluid was required for inclusion in this study. Empty or diluted aspirations were excluded.
Joint aspirations are performed by orthopaedic surgeons with an 18-gauge needle according to standardized aseptic technique. Intraoperative punctures are performed prior to arthrotomy. A minimum of 1ml of joint aspirate is immediately transferred to a native study vial for our study, a native vial for gram stain and culture and a native vial for polarization microscopy, respectively. A minimum of 1 ml joint aspirate is transferred to an ethylenediaminetetraacetic acid (EDTA) vial for the determination of leucocyte count. Finally, a minimum of 1 ml is inoculated into a paediatric blood culture bottle.
Standard microbiological methods are performed in an external laboratory that routinely collaborates with our clinic. Leucocyte count is performed automatically with the mentioned EDTA vial. Polarization microscopy is performed at our pathohistological department in order to detect crystals and signs of infection in joint aspirate.
If written informational consent has been signed by the patient, the study vial is immediately transported to our internal laboratory for analysis with new diagnostic methods (microcalorimetry, PCR, etc.). When an immediate transportation was not feasible, the vial is stored in a cooling fridge at +3° C until transportation was possible.
Each case is individually reviewed and classified by an experienced infectiologist taking the case's clinical history and laboratory results into account.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periprosthetic joint infection | – | –Patients with suspected periprosthetic joint infection of the hip, knee and shoulder |
| Septic arthritis | – | –Patients with suspected septic arthritis of a native joint of the hip, knee and shoulder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient with suspicion of septic arthritis or periprosthetic joint infection of the hip, knee and shoulder being diagnosed or treated in our facility in a clinical routine scenario willing to participate in this study (written informational consent)
Key inclusion criteria (4 listed)
- adult of 18 or more years
- written consent to participate in study
- suspicion of septic arthritis or periprosthetic joint infection
- joint aspirate minimum of 5 ml
Key exclusion criteria (2 listed)
- is not able to understand the aim or purpose of this study
- empty joint aspirate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
growth of microbial agent in culture of joint aspirate
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2015.
- Background: PubMed 25252631Yusuf E, Hugle T, Daikeler T, Voide C, Borens O, Trampuz A. The potential use of microcalorimetry in rapid differentiation between septic arthritis and other causes of arthritis. Eur J Clin Microbiol Infect Dis. 2015 Mar;34(3):461-5. doi: 10.1007/s10096-014-2248-y. Epub 2014 Sep 25.
- Background: PubMed 23138706Corvec S, Portillo ME, Pasticci BM, Borens O, Trampuz A. Epidemiology and new developments in the diagnosis of prosthetic joint infection. Int J Artif Organs. 2012 Oct;35(10):923-34. doi: 10.5301/ijao.5000168.
- Background: PubMed 15465503Trampuz A, Hanssen AD, Osmon DR, Mandrekar J, Steckelberg JM, Patel R. Synovial fluid leukocyte count and differential for the diagnosis of prosthetic knee infection. Am J Med. 2004 Oct 15;117(8):556-62. doi: 10.1016/j.amjmed.2004.06.022.
- Background: PubMed 15483283Zimmerli W, Trampuz A, Ochsner PE. Prosthetic-joint infections. N Engl J Med. 2004 Oct 14;351(16):1645-54. doi: 10.1056/NEJMra040181. No abstract available.
- Derived from this study: PubMed 40652382Lozano-Garcia M, Estrada-Petrocelli L, Roman RR, Jane R, Trampuz A, Morgenstern C. A Machine Learning Approach to Microcalorimetric Pattern Classification of Pathogens in Synovial Fluid. J Orthop Res. 2025 Oct;43(10):1855-1864. doi: 10.1002/jor.70024. Epub 2025 Jul 13.
- Derived from this study: PubMed 35395437Karbysheva S, Cabric S, Koliszak A, Bervar M, Kirschbaum S, Hardt S, Perka C, Trampuz A. Clinical evaluation of dithiothreitol in comparison with sonication for biofilm dislodgement in the microbiological diagnosis of periprosthetic joint infection. Diagn Microbiol Infect Dis. 2022 Jun;103(2):115679. doi: 10.1016/j.diagmicrobio.2022.115679. Epub 2022 Mar 12.
- Derived from this study: PubMed 32493292Morgenstern C, Renz N, Cabric S, Maiolo E, Perka C, Trampuz A. Thermogenic diagnosis of periprosthetic joint infection by microcalorimetry of synovial fluid. BMC Musculoskelet Disord. 2020 Jun 3;21(1):345. doi: 10.1186/s12891-020-03366-3.
- Derived from this study: PubMed 32290833Sigmund IK, Renz N, Feihl S, Morgenstern C, Cabric S, Trampuz A. Value of multiplex PCR for detection of antimicrobial resistance in samples retrieved from patients with orthopaedic infections. BMC Microbiol. 2020 Apr 14;20(1):88. doi: 10.1186/s12866-020-01741-7.
- Derived from this study: PubMed 30219763Morgenstern C, Renz N, Cabric S, Perka C, Trampuz A. Multiplex Polymerase Chain Reaction and Microcalorimetry in Synovial Fluid: Can Pathogen-based Detection Assays Improve the Diagnosis of Septic Arthritis? J Rheumatol. 2018 Nov;45(11):1588-1593. doi: 10.3899/jrheum.180311. Epub 2018 Sep 15.
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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.
Andrej Trampuz, MD principal investigator
Charité University Berlin
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 Periprosthetic Joint Infection and Septic Arthritis, run by Charite University, Berlin, Germany 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 4 inclusion and 2 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 21 Aug 2015. 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 Morgenstern, MD, PhD (+4930450652206, christian.morgenstern@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
growth of microbial agent in culture of joint aspirate (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02530229, which also lists 9 linked publications.
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 21 Aug 2015.