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Quality of Life in Patients Having a Prosthetic Joint Infection

Quality of Life in Patients Having a Prosthetic Joint Infection

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03307109
Acronym
QuaVIPA
Enrollment
154
Registered
2017-10-11
Start date
2017-10-17
Completion date
2026-03-03
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prosthetic Joint Infection, Quality of Life

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.

Interventions

OTHERQuality of life

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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Questionnaire EQ-5D-3L12 to 24 monthsEQ5D 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.
Analog Visual Scale12 to 24 monthsUse of a Analog Visual Scale to measure the quality of life

Secondary

MeasureTime frameDescription
Questionnaire EQ-5D-5L12 to 24 monthsIn 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026