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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2025
  • participants needed
    60
  • sponsor
    Groupe Hospitalier Diaconesses Croix Saint-Simon
Updated on 8 April 2022

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.

Details
Condition Prosthetic Joint Infection
Treatment Quality of life questionary
Clinical Study IdentifierNCT02805803
SponsorGroupe Hospitalier Diaconesses Croix Saint-Simon
Last Modified on8 April 2022

Eligibility

Yes No Not Sure

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
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