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

September 19, 2023 updated by: SMARMOR, Groupe Hospitalier Diaconesses Croix Saint-Simon

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75020
    • Ile De France
      • Paris, Ile De France, France, 75020
        • Recruiting
        • Groupe Hospitalier Dianconesses croix saint Simon
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Quality of life questionary

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
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.
Other Names:
  • Depressive symptoms questionary
  • Joint functional questionary

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. Depressive symptoms assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.
Time Frame: 2 years
Method assessment : Beck depression inventory (BDI)
2 years
2. Functional assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.
Time Frame: 2 years
Method assessment : Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
2 years
3. Evaluation of PSA side effects
Time Frame: 2 years
Method assessment : anamnesis and clinical examination
2 years
4. Evaluation of nutritional status
Time Frame: 2 years
Method assessment : BMI and proteinuria measurement
2 years
5. Evaluation of PSA termination criteria
Time Frame: 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 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Diaconesses Croix Saint-Simon

Investigators

  • Principal Investigator: Simon MARMOR, MD, Groupe Hospitalier Diaconesses Croix Saint-Simon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2016

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

June 15, 2016

First Submitted That Met QC Criteria

June 15, 2016

First Posted (Estimated)

June 20, 2016

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 19, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID RCB: 2015-A01702-47

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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