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

Not Applicable

Recruiting

• Conditions: Prosthetic Joint Infection

• Registration Number: NCT02805803
• Lead Sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon

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.

Study Timeline

• Study First Submitted: 2016-06-15
• Study First Submitted QC: 2016-06-15
• Study First Posted: 2016-06-20
• Study Start: 2016-11-09
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-19
• Last Update Posted: 2023-09-21
• Primary Completion: 2024-09-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Quality of life assessment of patients undergoing prolonged suppressive antibiotherapy for PJI.	2 years	Method assessment : Short Form 12 questionary (SF12)

Secondary Outcome Measures

Name	Time	Method
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
2. Functional assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.	2 years	Method assessment : Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
1. Depressive symptoms assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.	2 years	Method assessment : Beck depression inventory (BDI)

Trial Locations

Locations (2)

Groupe Hospitalier Dianconesses croix saint Simon; 🇫🇷 Paris, Ile De France, France

Groupe Hospitalier Diaconesses Croix saint Simon; 🇫🇷 Paris, France