Quality of Life in Patients Having a Prosthetic Joint Infection
QuaVIPA
1 other identifier
observational
250
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2017
CompletedFirst Posted
Study publicly available on registry
October 11, 2017
CompletedStudy Start
First participant enrolled
October 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
October 17, 2023
October 1, 2023
9 years
October 4, 2017
October 16, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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.
12 to 24 months
Analog Visual Scale
Use of a Analog Visual Scale to measure the quality of life
12 to 24 months
Secondary Outcomes (1)
Questionnaire EQ-5D-5L
12 to 24 months
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
Patients having an prosthetic joint infection
You may qualify if:
- Patient having prosthetic joint infection
- Patient who did not object to participate in the study
- Patients over 18 years of age
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre de reference des infections ostéo-articulaires de Lyon
Lyon, 69004, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2017
First Posted
October 11, 2017
Study Start
October 17, 2017
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2028
Last Updated
October 17, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share