Quality of Life Assessment in Patients Undergoing Prolonged Suppressive Antibiotherapy for Prosthetic Joint Infection. (PSA-QOL)
Primary Purpose
Prosthetic Joint Infection
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Quality of life questionary
Sponsored by
About this trial
This is an interventional health services research trial for Prosthetic Joint Infection
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Groupe Hospitalier Dianconesses croix saint SimonRecruiting
- Groupe Hospitalier Diaconesses Croix saint SimonRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Quality of life questionary
Arm Description
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
Outcomes
Primary Outcome Measures
Quality of life assessment of patients undergoing prolonged suppressive antibiotherapy for PJI.
Method assessment : Short Form 12 questionary (SF12)
Secondary Outcome Measures
1. Depressive symptoms assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.
Method assessment : Beck depression inventory (BDI)
2. Functional assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.
Method assessment : Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
3. Evaluation of PSA side effects
Method assessment : anamnesis and clinical examination
4. Evaluation of nutritional status
Method assessment : BMI and proteinuria measurement
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
Full Information
NCT ID
NCT02805803
First Posted
June 15, 2016
Last Updated
September 19, 2023
Sponsor
Groupe Hospitalier Diaconesses Croix Saint-Simon
1. Study Identification
Unique Protocol Identification Number
NCT02805803
Brief Title
Quality of Life Assessment in Patients Undergoing Prolonged Suppressive Antibiotherapy for Prosthetic Joint Infection.
Acronym
PSA-QOL
Official Title
Quality of Life Assessment in Patients Undergoing Prolonged Suppressive Antibiotherapy for Prosthetic Joint Infection.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 9, 2016 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Groupe Hospitalier Diaconesses Croix Saint-Simon
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthetic Joint Infection
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Quality of life questionary
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Quality of life questionary
Other Intervention Name(s)
Depressive symptoms questionary, Joint functional questionary
Intervention Description
Patients will be asked to fill out the questionaries before treatment initiation and at 3, 6 , 12 and 24 months after antibiotherapy initiation.
Primary Outcome Measure Information:
Title
Quality of life assessment of patients undergoing prolonged suppressive antibiotherapy for PJI.
Description
Method assessment : Short Form 12 questionary (SF12)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
1. Depressive symptoms assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.
Description
Method assessment : Beck depression inventory (BDI)
Time Frame
2 years
Title
2. Functional assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.
Description
Method assessment : Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame
2 years
Title
3. Evaluation of PSA side effects
Description
Method assessment : anamnesis and clinical examination
Time Frame
2 years
Title
4. Evaluation of nutritional status
Description
Method assessment : BMI and proteinuria measurement
Time Frame
2 years
Title
5. Evaluation of PSA termination criteria
Description
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
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Younes KERROUMI, MD
Phone
(+33) 1 44 64 33 84
Email
ykerroumi@hopital-dcss.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon MARMOR, MD
Organizational Affiliation
Groupe Hospitalier Diaconesses Croix Saint-Simon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier Dianconesses croix saint Simon
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Younes KERROUMI, Doctorate
Phone
01 44 64 33 84
Email
ykerroumi@hopital-dcss.org
Facility Name
Groupe Hospitalier Diaconesses Croix saint Simon
City
Paris
ZIP/Postal Code
75020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon MARMOR, MD
Phone
0033144641640
Email
smarmor@hopital-dcss.org
First Name & Middle Initial & Last Name & Degree
Valérie ZELLER, MD
Phone
0033144641780
Email
vzeller@hopital-dcss.org
12. IPD Sharing Statement
Plan to Share IPD
No
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Quality of Life Assessment in Patients Undergoing Prolonged Suppressive Antibiotherapy for Prosthetic Joint Infection.
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