Prosthetic Joint Infection
Conditions
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: 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.
Interventions
OTHERQuality 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.
Sponsors
Groupe Hospitalier Diaconesses Croix Saint-Simon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life assessment of patients undergoing prolonged suppressive antibiotherapy for PJI. | 2 years | Method assessment : Short Form 12 questionary (SF12) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1. Depressive symptoms assessment in patients undergoing prolonged suppressive antibiotherapy for PJI. | 2 years | Method assessment : Beck depression inventory (BDI) |
| 2. Functional assessment in patients undergoing prolonged suppressive antibiotherapy for PJI. | 2 years | Method assessment : Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) |
| 3. Evaluation of PSA side effects | 2 years | Method assessment : anamnesis and clinical examination |
| 4. Evaluation of nutritional status | 2 years | Method assessment : BMI and proteinuria measurement |
| 5. Evaluation of PSA termination criteria | 2 years | 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 |
Countries
France
Contacts
Primary ContactYounes KERROUMI, MD
Outcome results
None listed