Prosthetic Joint InfectionPSA-QOLNCT02805803
Quality of Life Assessment in Patients Undergoing Prolonged Suppressive Antibiotherapy for Prosthetic Joint Infection.
A study testing Quality of life questionary in people with Prosthetic Joint Infection, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 2 sites in France.
Trial summary
Prosthetic joint infection (PJI) management is complex and requires prosthesis replacement when symptoms duration is greater than 30 days or debridement with modular set replacement when symptoms duration is lesser than one month. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthetic Joint Infection
- What is being tested?
- Quality of life questionary
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 9 Nov 2016to 30 Jun 2025
- 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 aged over 18 years old with hip or knee prosthetic infection who consented to participate in the study
- Non-eligible patient to surgical treatment
- Patient eligible to prolonged suppressive antibiotherapy
Who cannot join
- patient who does not meet eligibility criteria
- Patient living or traveling abroad for whom 2 years minimum follow up is impossible.
- Patient lawfully deprived of his liberty
- Patient not insured under social security scheme
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 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
- Recruiting
Groupe Hospitalier Dianconesses croix saint Simon
Paris, Île-de-France Region, 75020
Younes KERROUMI, Doctorate, 01 44 64 33 84, ykerroumi@hopital-dcss.org
About this study
Prosthetic joint infection (PJI) management is complex and requires prosthesis replacement when symptoms duration is greater than 30 days or debridement with modular set replacement when symptoms duration is lesser than one month. Nevertheless, the prolonged suppressive antibiotherapy (PSA) is the single treatment we can provide to high risk surgical patients and those who refuse reoperation.
There is limited data available on PSA modality, its tolerance and efficacy, this lack of data motivated us to concept a prospective study of long term patient follow up with PJI treated with prolonged suppressive antibiotherapy.
Read the detailed description
Main objective:
Quality of life assessment of patients undergoing prolonged suppressive antibiotherapy for PJI.
Secondary objectives:
- Depressive symptoms assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.
- Functional assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.
- Evaluation of PSA side effects
- Evaluation of nutritional status
- Evaluation of of PSA termination criteria
Methods:
The follow up oh this cohort will be conducted using 3 questionaries related to quality of life, joint stiffness and depressive symptoms.
Study type:
This is a study of health care procedure, evaluating the quality of life of patients undergoing prolonged suppressive antibiotherapy for PJI.
Sample size: all patients cared by our referral center of bone and joint infection, who meet protocol selection criteria will be included in the study, thus we are expecting to recruit 60 patients.
Study duration: 6 years.
Recruitment period: 4 years.
Maximal duration of data collection: 2 years.
Investigator center: Single center study.
Mean patient inclusion per year: 15 patients per year.
- Conditions
- Prosthetic Joint Infection
- Being tested
- Quality of life questionary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life questionaryOther
Also called Depressive symptoms questionary, Joint functional questionary
Patients will be asked to fill out the questionaries before treatment initiation and at 3, 6 , 12 and 24 months after antibiotherapy initiation.
| Study group | Role | What they receive |
|---|---|---|
| Quality of life questionary | Other | During this study of health and care procedure, we will assess the quality of life of patients treated with suppressive antibiotique therapy using three questionaries:
* SF12
* Beck
* WOMAC Receives: Other: Quality of life questionary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life assessment of patients undergoing prolonged suppressive antibiotherapy for PJI.
Method assessment : Short Form 12 questionary (SF12)
Measured: 2 years
Secondary outcomes (5)
1. Depressive symptoms assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.
Method assessment : Beck depression inventory (BDI)
Measured: 2 years
2. Functional assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.
Method assessment : Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Measured: 2 years
3. Evaluation of PSA side effects
Method assessment : anamnesis and clinical examination
Measured: 2 years
4. Evaluation of nutritional status
Method assessment : BMI and proteinuria measurement
Measured: 2 years
5. Evaluation of PSA termination criteria
Monitoring :
- Treatment failure in case of :
- Side effects
- Relapse of the infection
- Persistance of the infection
- The patient wishes terminate the treatment because of :
- Side effects
- The infection is controlled
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 posted20 Jun 2016 (estimated)
- Study start9 Nov 2016
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Jun 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT02805803
- Sponsor's protocol ID
- ID RCB: 2015-A01702-47
- Acronym
- PSA-QOL
- Status last verified
- Sep 2023
- First submitted
- 15 Jun 2016
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Assessment in Patients Undergoing Prolonged Suppressive Antibiotherapy for Prosthetic Joint Infection.
- ClinicalTrials.gov ID
- NCT02805803
- Acronym / sponsor ID
- PSA-QOL / ID RCB: 2015-A01702-47
- Conditions
- Prosthetic Joint Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-SimonUniversity, hospital or other
- Study start
- 9 Nov 2016 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 20 Jun 2016 (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.
Prosthetic joint infection (PJI) management is complex and requires prosthesis replacement when symptoms duration is greater than 30 days or debridement with modular set replacement when symptoms duration is lesser than one month. Nevertheless, the prolonged suppressive antibiotherapy (PSA) is the single treatment we can provide to high risk surgical patients and those who refuse reoperation.
There is limited data available on PSA modality, its tolerance and efficacy, this lack of data motivated us to concept a prospective study of long term patient follow up with PJI treated with prolonged suppressive antibiotherapy.
Detailed description
Main objective:
Quality of life assessment of patients undergoing prolonged suppressive antibiotherapy for PJI.
Secondary objectives:
- Depressive symptoms assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.
- Functional assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.
- Evaluation of PSA side effects
- Evaluation of nutritional status
- Evaluation of of PSA termination criteria
Methods:
The follow up oh this cohort will be conducted using 3 questionaries related to quality of life, joint stiffness and depressive symptoms.
Study type:
This is a study of health care procedure, evaluating the quality of life of patients undergoing prolonged suppressive antibiotherapy for PJI.
Sample size: all patients cared by our referral center of bone and joint infection, who meet protocol selection criteria will be included in the study, thus we are expecting to recruit 60 patients.
Study duration: 6 years.
Recruitment period: 4 years.
Maximal duration of data collection: 2 years.
Investigator center: Single center study.
Mean patient inclusion per year: 15 patients per year.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quality of life questionary | Other | Other: Quality of life questionaryDuring this study of health and care procedure, we will assess the quality of life of patients treated with suppressive antibiotique therapy using three questionaries: * SF12 * Beck * WOMAC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient aged over 18 years old with hip or knee prosthetic infection who consented to participate in the study
- Non-eligible patient to surgical treatment
- Patient eligible to prolonged suppressive antibiotherapy
Key exclusion criteria (4 listed)
- patient who does not meet eligibility criteria
- Patient living or traveling abroad for whom 2 years minimum follow up is impossible.
- Patient lawfully deprived of his liberty
- Patient not insured under social security scheme
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 |
|---|---|---|
| Quality of life questionaryAlso: Depressive symptoms questionary, Joint functional questionaryPatients will be asked to fill out the questionaries before treatment initiation and at 3, 6 , 12 and 24 months after antibiotherapy initiation. | Other | Quality of life questionary |
Primary outcome
Quality of life assessment of patients undergoing prolonged suppressive antibiotherapy for PJI.
Time frame: 2 years
Method assessment : Short Form 12 questionary (SF12)
5 secondary outcomes
1. Depressive symptoms assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.
Time frame: 2 years
2. Functional assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.
Time frame: 2 years
3. Evaluation of PSA side effects
Time frame: 2 years
4. Evaluation of nutritional status
Time frame: 2 years
5. Evaluation of PSA termination criteria
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- 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.
Simon MARMOR, MD principal investigator
Groupe Hospitalier Diaconesses Croix Saint-Simon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality of life questionary in people with Prosthetic Joint Infection, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 2 sites 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 3 inclusion and 4 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 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 2 sites 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 ((+33) 1 44 64 33 84, ykerroumi@hopital-dcss.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life assessment of patients undergoing prolonged suppressive antibiotherapy for PJI. (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 21 Sep 2023.