Quality of Life in Patients Having a Prosthetic Joint Infection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospices Civils de Lyon
About this trial
Bone and joint infections (BJI) are rare serious pathology which can lead to a very heavy handicap and sometimes to the life threatening. These are devastating diseases whose diagnosis is difficult. They are known to be associated with high mortality rates (5%) and significant morbidities responsible for functional sequelae (40% of patients) with an individual cost (prolonged hospitalization, altered quality of life) and societal (work stoppage, partial or total disability, temporary or permanent) extremely high.
These bone and joint infections have a significant impact on the quality of life of those affected who, in addition to their infection, are reduced in their autonomy and often need to be taken care of outside their home, sometimes away from home.
To the knowledge of investigators, there are few studies on the measurement of quality of life in patients with osteoarticular infection.
The aim of this study is to implement the EQ-5D-3L validated quality of life questionnaire and the EVA scale (created by EuroQol Group) for each patient with a prosthetic joint infection (IPA) on prosthesis during their medical care in the department of Infectious and Tropical Diseases.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient having prosthetic joint infection
Patient who did not object to participate in the study
Patients over 18 years of age
Disqualifiers
Patient with additional psychological or psychiatric support outside the service.
Patient benefiting from a system of legal protection (safeguard of justice, guardianship, curatorship)
Patient participating in another study on measuring quality of life
Patients with cognitive impairment to understand the questionnaire
Trial population
Patients having an prosthetic joint infection
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Quality of life
Other interventionPatients will complete two EQ-5D-5L and EQ-5D-3L quality of life questionnaires and will complete an analog visual scale during each of their follow-up visits to the Infectious and Tropical Diseases Department of Croix-Rousse hospital. No visits will be added to complete the questionnaires.
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Patients having prosthetic joint infection1 intervention
Trial outcomes
Primary outcomes
1
Questionnaire EQ-5D-3L
EQ5D is one of the most widely used health states descriptive system and has a valuation in France. EQ-5D questionnaires have 5 dimensions: "Mobility", "Human Autonomy," "Current Activities", "Pain / Discomfort", "Anxiety / Depression" and all dimensions are described by 3 problem levels corresponding to patient response choices. A quality of life score is obtained according to the answers to the questionnaires.
Time frame
12 to 24 months2
Analog Visual Scale
Use of a Analog Visual Scale to measure the quality of life
Time frame
12 to 24 monthsSecondary outcomes
1
Questionnaire EQ-5D-5L
In the EQ-5D-5L the 5 dimensions are described by 5 problem levels corresponding to patient response choices. A quality of life score is obtained according to the answers to the questionnaires. In France, only the EQ-5D-3L has been validated, not yet the EQ-5D-5L which has only been translated. In this study investigators want compare the score obtained to the questionnaires EQ5D-5L and EQ-5D-3L to determine if EQ-5D-5L is more adapted to patients having prosthetic joint infection.
Time frame
12 to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov