Joint Prosthesis; ComplicationsJAD-ProNCT06054711
Joint Aspiration in Dysfunctional Hip, Knee or Shoulder Prostheses
A study testing joint puncture in people with Joint Prosthesis; Complications, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 1 site in France.
Trial summary
After a hip, knee or shoulder arthroplasty, the evolution is not always favorable. It can be marked by an infectious or non-infectious complication, most often implant failure. In this context, joint fluid aspiration (JFA) is indicated to document a prosthetic joint infection (PJI) or to bring to light arguments for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Joint Prosthesis; Complications
- What is being tested?
- joint puncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 7 Feb 2022to 7 Aug 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient consent to participate in the study.
- Patient aged over 18 years
- Patient with hip, knee or shoulder joint prosthesis
- Patient who has the Indication to perform a FJA, whatever the cause of revision (mechanical, septic)
- Over one-month symptoms evolution for patients suspected of infection
Who cannot join
- Acute prosthesis infection with less than one-month symptoms' duration
- Antibiotic therapy between preoperative FJA and intraoperative samples
- Pregnant or breastfeeding woman.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Groupe Hospitalier Diaconesses Croix saint Simon
Paris, 75020
Simon MARMOR, MD, 0033144641640, smarmor@hopital-dcss.org
Valérie ZELLER, MD, 0033144641780, vzeller@hopital-dcss.org
About this study
Official title: Joint Aspiration in Dysfunctional Hip, Knee or Shoulder Prostheses (Chronic Infection or Implant Failure) "JAD-Pro"
After a hip, knee or shoulder arthroplasty, the evolution is not always favorable. It can be marked by an infectious or non-infectious complication, most often implant failure. In this context, joint fluid aspiration (JFA) is indicated to document a prosthetic joint infection (PJI) or to bring to light arguments for implant failure. Nevertheless, opinions differ on its indication for microbiological identification. Some teams perform it systematically when faced with a prosthesis dysfunction. Others, only in the presence of suggestive signs of PJI. Finally, others never perform it.
Based on clinical, radiological and biological (CRP) signs, at the preoperative stage and before JFA, we classify our patients into 3 groups: supposedly septic (chronic joint infection), supposedly aseptic (implant failure) or intermediate (Unknown). This last group, often encountered in consultation, poses a diagnosis problem more than the others.
Read more
In our experience, JFA is an essential diagnosis tool in these 3 groups of patients. It helps to choose the surgical strategy. In addition, the dosage of biomarkers in the joint fluid as the alpha defensin, the leucocyte esterase and the CRP could provide an additional argument to investigate the infectious origin or not, in particular in difficult cases.
In summary, the disagreement on the usefulness of JFA in case of PJI suspicion and any other prosthetic dysfunction, the lack of data on large prospective studies and our questioning about the contribution of JFA in the aseptic and intermediate group of patients, motivated us to set up this study to evaluate the interest of the JFA for the preoperative diagnosis, as well as that of the dosage of biomarkers in the joint fluid.
Read the detailed description
Visit V0: corresponds to the first consultation. After informing and obtaining the consent of the patient, the investigator will collect the anamnesis, clinical, radiological and biological data, then will indicate the anticipated medico-surgical strategy. The FJA will be prescribed during this consultation, as well as the dosage of the CRP in blood the same day as the FJA.
Then, the investigator will classify the patient (primary classification) in one of the three groups the groups: supposedly septic, supposedly aseptic or intermediate.
A reclassification of patients (secondary classification) will be done, based on the bacteriological results of the FJA (positive, negative and doubtful). Biomarker results will not be disclosed or considered for patient care.
Visit V1: corresponds to the day of the FJA in the x.ray department and the blood sample in the central laboratory for the CRP dosage.
During FJA, 2 ml of additional joint fluid will be collected in addition to the volume usually collected for CRP, Leukocyte Esterase and alpha defensin dosage in joint fluid. Alpha defensin dosage will be performed only in patients in the intermediate group with a negative FJA.
Visit V2: Day of prosthesis revision in the event of chronic PJI or mechanical prosthesis dysfunction (Implant failure) requiring surgery.
- Conditions
- Joint Prosthesis; Complications
- Being tested
- joint puncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
joint punctureOther
Patients reporting complications such as pain hindering mobility or affecting quality of life, or any other symptoms suspecting prosthesis failure or infection will undergo joint fluid aspiration.
| Study group | Role | What they receive |
|---|---|---|
| Joint Fluid Aspiration | Other | all included patients reporting prothesis complication will undergo a joint fluid aspiration Receives: Other: joint puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the bacteriological concordance between JFA and perioperative samples
Number of patients whose JFA is concordant with that of the perioperative samples
Measured: From JFA till perioperative samples bacteriological analysis termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start7 Feb 2022
- Primary completion7 Feb 2024 (estimated)
- Study completion7 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint Prosthesis; ComplicationsStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohorte study
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-Simon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SMARMOR, Groupe Hospitalier Diaconesses Croix Saint-Simon
- Investigators
- Simon MARMOR, MD, Principal investigator, Groupe Hospitalier Diaconesses Croix Saint-Simon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054711
- Sponsor's protocol ID
- 2020-A00466-33
- Acronym
- JAD-Pro
- Status last verified
- Sep 2023
- First submitted
- 19 Sep 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Joint Aspiration in Dysfunctional Hip, Knee or Shoulder Prostheses (Chronic Infection or Implant Failure) "JAD-Pro"
- ClinicalTrials.gov ID
- NCT06054711
- Acronym / sponsor ID
- JAD-Pro / 2020-A00466-33
- Conditions
- Joint Prosthesis; Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-SimonUniversity, hospital or other
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 7 Feb 2024 (estimated)
- Study completion
- 7 Aug 2024 (estimated)
- First posted
- 26 Sep 2023 (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.
After a hip, knee or shoulder arthroplasty, the evolution is not always favorable. It can be marked by an infectious or non-infectious complication, most often implant failure. In this context, joint fluid aspiration (JFA) is indicated to document a prosthetic joint infection (PJI) or to bring to light arguments for implant failure. Nevertheless, opinions differ on its indication for microbiological identification. Some teams perform it systematically when faced with a prosthesis dysfunction. Others, only in the presence of suggestive signs of PJI. Finally, others never perform it.
Based on clinical, radiological and biological (CRP) signs, at the preoperative stage and before JFA, we classify our patients into 3 groups: supposedly septic (chronic joint infection), supposedly aseptic (implant failure) or intermediate (Unknown). This last group, often encountered in consultation, poses a diagnosis problem more than the others.
In our experience, JFA is an essential diagnosis tool in these 3 groups of patients. It helps to choose the surgical strategy. In addition, the dosage of biomarkers in the joint fluid as the alpha defensin, the leucocyte esterase and the CRP could provide an additional argument to investigate the infectious origin or not, in particular in difficult cases.
In summary, the disagreement on the usefulness of JFA in case of PJI suspicion and any other prosthetic dysfunction, the lack of data on large prospective studies and our questioning about the contribution of JFA in the aseptic and intermediate group of patients, motivated us to set up this study to evaluate the interest of the JFA for the preoperative diagnosis, as well as that of the dosage of biomarkers in the joint fluid.
Detailed description
Visit V0: corresponds to the first consultation. After informing and obtaining the consent of the patient, the investigator will collect the anamnesis, clinical, radiological and biological data, then will indicate the anticipated medico-surgical strategy. The FJA will be prescribed during this consultation, as well as the dosage of the CRP in blood the same day as the FJA.
Then, the investigator will classify the patient (primary classification) in one of the three groups the groups: supposedly septic, supposedly aseptic or intermediate.
A reclassification of patients (secondary classification) will be done, based on the bacteriological results of the FJA (positive, negative and doubtful). Biomarker results will not be disclosed or considered for patient care.
Visit V1: corresponds to the day of the FJA in the x.ray department and the blood sample in the central laboratory for the CRP dosage.
During FJA, 2 ml of additional joint fluid will be collected in addition to the volume usually collected for CRP, Leukocyte Esterase and alpha defensin dosage in joint fluid. Alpha defensin dosage will be performed only in patients in the intermediate group with a negative FJA.
Visit V2: Day of prosthesis revision in the event of chronic PJI or mechanical prosthesis dysfunction (Implant failure) requiring surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohorte study
| Arm | Type | Receives |
|---|---|---|
| Joint Fluid Aspiration | Other | Other: joint punctureall included patients reporting prothesis complication will undergo a joint fluid aspiration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient consent to participate in the study.
- Patient aged over 18 years
- Patient with hip, knee or shoulder joint prosthesis
- Patient who has the Indication to perform a FJA, whatever the cause of revision (mechanical, septic)
- Over one-month symptoms evolution for patients suspected of infection
Key exclusion criteria (3 listed)
- Acute prosthesis infection with less than one-month symptoms' duration
- Antibiotic therapy between preoperative FJA and intraoperative samples
- Pregnant or breastfeeding woman.
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 |
|---|---|---|
| joint puncturePatients reporting complications such as pain hindering mobility or affecting quality of life, or any other symptoms suspecting prosthesis failure or infection will undergo joint fluid aspiration. | Other | Joint Fluid Aspiration |
Primary outcome
Analysis of the bacteriological concordance between JFA and perioperative samples
Time frame: From JFA till perioperative samples bacteriological analysis termination
Number of patients whose JFA is concordant with that of the perioperative samples
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
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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.
Simon MARMOR, MD principal investigator
Groupe Hospitalier Diaconesses Croix Saint-Simon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing joint puncture in people with Joint Prosthesis; Complications, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 1 site in France.
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 5 inclusion and 3 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 26 Sep 2023. 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 France. 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 Younes KERROUMI, MD (+33144643384, ykerroumi@hopital-dcss.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of the bacteriological concordance between JFA and perioperative samples (time frame: From JFA till perioperative samples bacteriological analysis termination). 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 26 Sep 2023; AzTrials last refreshed its copy on 1 Nov 2026.