NCT02805803

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prosthetic Joint Infection

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2016-11-09
• Primary completion: 2024-09-30
• Completion: 2025-06-30
• First posted: 2016-06-20
• Last updated: 2023-09-21

Locations

2 sites across 1 country: France