Quality of Life Assessment in Patients Undergoing Prolonged Suppressive

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02805803
Study type	Interventional
Source	Groupe Hospitalier Diaconesses Croix Saint-Simon
Contact	Younes KERROUMI, MD
Phone	(+33) 1 44 64 33 84
Email	ykerroumi@hopital-dcss.org
Status	Recruiting
Phase	N/A
Start date	November 9, 2016
Completion date	June 30, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms