Quality of Life Assessment in Patients Undergoing Prolonged Suppressive Antibiotherapy for Prosthetic Joint Infection. (PSA-QOL)

Groupe Hospitalier Diaconesses Croix Saint-Simon

Status: Enrolling

Conditions: Prosthetic Joint Infection

Treatments: Other: Quality of life questionary

Study type: Interventional

Funder types: Other

Identifiers

NCT02805803

ID RCB: 2015-A01702-47

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Quality of life questionary

Other group

Description:

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

Treatment:

Other: Quality of life questionary