Quality of Life Assessment in Patients Undergoing Prolonged Suppressive Antibiotherapy for Prosthetic Joint Infection.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Quality of Life Assessment in Patients Undergoing Prolonged Suppressive Antibiotherapy for Prosthetic Joint Infection.

Conditions
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Prosthetic Joint Infection

Intervention / Treatment
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* Other: Quality of life questionary


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Quality of life questionary<br>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 | Other: Quality of life questionary<br>* Patients will be asked to fill out the questionaries before treatment initiation and at 3, 6 , 12 and 24 months after antibiotherapy initiation.<br>* Other names: Joint functional questionary;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life assessment of patients undergoing prolonged suppressive antibiotherapy for PJI. | Method assessment : Short Form 12 questionary (SF12) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Depressive symptoms assessment in patients undergoing prolonged suppressive antibiotherapy for PJI. | Method assessment : Beck depression inventory (BDI) | 2 years | 
| 2. Functional assessment in patients undergoing prolonged suppressive antibiotherapy for PJI. | Method assessment : Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 2 years | 
| 3. Evaluation of PSA side effects | Method assessment : anamnesis and clinical examination | 2 years | 
| 4. Evaluation of nutritional status | Method assessment : BMI and proteinuria measurement | 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 | 2 years |