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Recruiting NCT03307109

Quality of Life in Patients Having a Prosthetic Joint Infection

Observational Quality of Life Prosthetic Joint Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Quality of life.
Who it may be relevant to
Registry conditions: Quality of Life, Prosthetic Joint Infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Other Quality 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.

Primary outcome measures

  • Questionnaire EQ-5D-3L [Time frame: 12 to 24 months]
  • Analog Visual Scale [Time frame: 12 to 24 months]
Secondary outcome measures (1)
  • Questionnaire EQ-5D-5L [Time frame: 12 to 24 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Centre de reference des infections ostéo-articulaires de Lyon — Lyon

Identifiers

NCT: NCT03307109 · 69HCL17_0419

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗