Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-24 @ 7:47 PM
NCT ID:
NCT02805803
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 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:
NCT02805803
Study Brief:
Protocol Section:
NCT02805803