Clinical trial NCT02805803: Quality of Life Assessment in Patients Undergoing Prolonged Suppressive Antibiotherapy for Prosthetic Joint Infection.
Official title: Quality of Life Assessment in Patients Undergoing Prolonged Suppressive Antibiotherapy for Prosthetic Joint Infection.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prosthetic Joint Infection
Lead sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon
Sponsor class: OTHER
First posted: 2016-06-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of life assessment of patients undergoing prolonged suppressive antibiotherapy for PJI.
timeFrame: 2 years
Secondary outcomes:
measure: 1. Depressive symptoms assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.
timeFrame: 2 years
measure: 2. Functional assessment in patients undergoing prolonged suppressive antibiotherapy for PJI.
timeFrame: 2 years
measure: 3. Evaluation of PSA side effects
timeFrame: 2 years
measure: 4. Evaluation of nutritional status
timeFrame: 2 years
measure: 5. Evaluation of PSA termination criteria
timeFrame: 2 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Dianconesses croix saint Simon
state: Ile De France
city: Paris
country: France
facility: Groupe Hospitalier Diaconesses Croix saint Simon
Study officials:
affiliation: Groupe Hospitalier Diaconesses Croix Saint-Simon
name: Simon MARMOR, MD
role: PRINCIPAL_INVESTIGATOR
References: