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

Prosthetic Joint Infection Clinical Trial

— PSA-QOL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02805803
• Other study ID #: ID RCB: 2015-A01702-47
• Status: Recruiting
• Phase: N/A
• Start date: November 9, 2016
• Est. completion date: June 30, 2025

Study information

• Verified date: September 2023
• Source: Groupe Hospitalier Diaconesses Croix Saint-Simon
• Contact: Younes KERROUMI, MD
• Phone: (+33) 1 44 64 33 84
• Email: ykerroumi[@]hopital-dcss.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Infectious
• Communicable Diseases
• Infections
• Prosthetic Joint Infection

Intervention

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.

Locations

Country	Name	City	State
France	Groupe Hospitalier Diaconesses Croix saint Simon	Paris
France	Groupe Hospitalier Dianconesses croix saint Simon	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Diaconesses Croix Saint-Simon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life assessment of patients undergoing prolonged suppressive antibiotherapy for PJI.	Method assessment : Short Form 12 questionary (SF12)	2 years
Secondary	1. Depressive symptoms assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.	Method assessment : Beck depression inventory (BDI)	2 years
Secondary	2. Functional assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.	Method assessment : Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	2 years
Secondary	3. Evaluation of PSA side effects	Method assessment : anamnesis and clinical examination	2 years
Secondary	4. Evaluation of nutritional status	Method assessment : BMI and proteinuria measurement	2 years
Secondary	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