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CompletedNCT03307109QuaVIPAUpdated Sep 9, 2026

Quality of Life in Patients Having a Prosthetic Joint Infection

An observational study in Quality of Life and Prosthetic Joint Infection, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Hospices Civils de Lyon · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
154
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Quality of Life
  • Prosthetic Joint Infection
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients having an prosthetic joint infection

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
154 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Other: Quality of life

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.

05

What researchers measure

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 months

  2. Analog Visual Scale

    Use of a Analog Visual Scale to measure the quality of life

    Time frame: 12 to 24 months

Secondary 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 months

06

Study locations

1 site
  • Centre de reference des infections ostéo-articulaires de Lyon
    Lyon, 69004, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03307109
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Oct 11, 2017
Start date
Oct 17, 2017
Primary completion
Mar 3, 2026
Completion
Mar 3, 2026
Last update
Sep 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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