Quality of Life Assessment in Patients Undergoing Prolonged Suppressive Antibiotherapy for Prosthetic Joint Infection.
NCT ID: NCT02805803
Last Updated: 2023-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2016-11-09
2025-06-30
Brief Summary
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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.
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Detailed Description
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Quality of life assessment of patients undergoing prolonged suppressive antibiotherapy for PJI.
Secondary objectives:
1. Depressive symptoms assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.
2. Functional assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.
3. Evaluation of PSA side effects
4. Evaluation of nutritional status
5. 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
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Quality of life questionary
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
Quality of life questionary
Patients will be asked to fill out the questionaries before treatment initiation and at 3, 6 , 12 and 24 months after antibiotherapy initiation.
Interventions
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Quality of life questionary
Patients will be asked to fill out the questionaries before treatment initiation and at 3, 6 , 12 and 24 months after antibiotherapy initiation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Non-eligible patient to surgical treatment
* Patient eligible to prolonged suppressive antibiotherapy
Exclusion 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
18 Years
ALL
No
Sponsors
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Groupe Hospitalier Diaconesses Croix Saint-Simon
OTHER
Responsible Party
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SMARMOR
Director
Principal Investigators
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Simon MARMOR, MD
Role: PRINCIPAL_INVESTIGATOR
Groupe Hospitalier Diaconesses Croix Saint-Simon
Locations
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Groupe Hospitalier Diaconesses Croix saint Simon
Paris, , France
Groupe Hospitalier Dianconesses croix saint Simon
Paris, Île-de-France Region, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ID RCB: 2015-A01702-47
Identifier Type: -
Identifier Source: org_study_id
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