Quality of Life in Patients Having a Prosthetic Joint Infection (QuaVIPA)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Lyon, France, 69004
- Centre de reference des infections ostéo-articulaires de Lyon
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient having prosthetic joint infection
- Patient who did not object to participate in the study
- Patients over 18 years of age
Exclusion Criteria:
- 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
- Impossibility of giving the patient informed information
- Patients with no infection diseases follow up at the CROIX ROUSSE hospital
- Patients with amputation as initial surgery for infection management
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Patients having prosthetic joint infection
The primary aim is to measure the evolution of quality of life in patients having prosthetic joint infection during their medical care and possibly psychologic assistance in the Infectious and Tropical Diseases Department of Croix-Rousse Hospital.
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Patients 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Questionnaire EQ-5D-3L
Time Frame: 12 to 24 months
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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. |
12 to 24 months
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Analog Visual Scale
Time Frame: 12 to 24 months
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Use of a Analog Visual Scale to measure the quality of life
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12 to 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Questionnaire EQ-5D-5L
Time Frame: 12 to 24 months
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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. |
12 to 24 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL17_0419
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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