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.
Main objective: 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
60
Patients will be asked to fill out the questionaries before treatment initiation and at 3, 6 , 12 and 24 months after antibiotherapy initiation.
Groupe Hospitalier Diaconesses Croix saint Simon
Paris, France
RECRUITINGGroupe Hospitalier Dianconesses croix saint Simon
Paris, Île-de-France Region, France
RECRUITINGQuality of life assessment of patients undergoing prolonged suppressive antibiotherapy for PJI.
Method assessment : Short Form 12 questionary (SF12)
Time frame: 2 years
1. Depressive symptoms assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.
Method assessment : Beck depression inventory (BDI)
Time frame: 2 years
2. Functional assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.
Method assessment : Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 2 years
3. Evaluation of PSA side effects
Method assessment : anamnesis and clinical examination
Time frame: 2 years
4. Evaluation of nutritional status
Method assessment : BMI and proteinuria measurement
Time frame: 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
Time frame: 2 years
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