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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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 Summary:

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
Sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon

Current Primary Outcome: Quality of life assessment of patients undergoing prolonged suppressive antibiotherapy for PJI. [ Time Frame: 2 years ]

Method assessment : Short Form 12 questionary (SF12)


Original Primary Outcome: Quality of life assessment of patients undergoing prolonged suppressive antibiotherapy for PJI. [ Time Frame: 2 years ]

Current Secondary Outcome:

  • 1. Depressive symptoms assessment in patients undergoing prolonged suppressive antibiotherapy for PJI. [ Time Frame: 2 years ]
    Method assessment : Beck depression inventory (BDI)
  • 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)
  • 3. Evaluation of PSA side effects [ Time Frame: 2 years ]
    Method assessment : anamnesis and clinical examination
  • 4. Evaluation of nutritional status [ Time Frame: 2 years ]
    Method assessment : BMI and proteinuria measurement
  • 5. Evaluation of PSA termination criteria [ Time Frame: 2 years ]


Original Secondary Outcome:

  • 1. Depressive symptoms assessment in patients undergoing prolonged suppressive antibiotherapy for PJI. [ Time Frame: 2 years ]
  • 2. Functional assessment in patients undergoing prolonged suppressive antibiotherapy for PJI. [ Time Frame: 2 years ]
  • 3. Evaluation of PSA side effects [ Time Frame: 2 years ]
  • 4. Evaluation of nutritional status [ Time Frame: 2 years ]
  • 5. Evaluation of of PSA termination criteria [ Time Frame: 2 years ]


Information By: Groupe Hospitalier Diaconesses Croix Saint-Simon

Dates:
Date Received: June 15, 2016
Date Started: November 9, 2016
Date Completion: September 2022
Last Updated: January 25, 2017
Last Verified: January 2017