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Quality of Life in Patients Having a Prosthetic Joint Infection (QuaVIPA)

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ClinicalTrials.gov Identifier: NCT03307109
Recruitment Status : Recruiting
First Posted : October 11, 2017
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment
Quality of Life Prosthetic Joint Infection Other: Quality of life

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life in Patients Having a Prosthetic Joint Infection
Actual Study Start Date : September 28, 2017
Estimated Primary Completion Date : September 28, 2021
Estimated Study Completion Date : September 28, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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 :
  1. Questionnaire EQ-5D-3L [ Time Frame: 12 months ]

    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.


  2. Analog Visual Scale [ Time Frame: 12 months ]
    Use of a Analog Visual Scale to measure the quality of life


Secondary Outcome Measures :
  1. Questionnaire EQ-5D-5L [ Time Frame: 12 months ]

    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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients having an prosthetic joint infection
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03307109


Contacts
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Contact: Tristan FERRY, MD, PhD 04 72 07 11 07 ext +33 tristan.ferry@chu-lyon.fr
Contact: Eugénie MABRUT 04 26 73 29 38 ext +33 eugenie.mabrut@chu-lyon.fr

Locations
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France
Centre de reference des infections ostéo-articulaires de Lyon Recruiting
Lyon, France, 69004
Contact: Tristan FERRY, MD, PhD    04 72 07 11 07 ext +33    tristan.ferry@chu-lyon.fr   
Contact: Eugénie MABRUT    04 26 73 29 38 ext +33    eugenie.mabrut@chu-lyon.fr   
Principal Investigator: Tristan FERRY, MD, PhD         
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03307109     History of Changes
Other Study ID Numbers: 69HCL17_0419
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Arthritis, Infectious
Arthritis
Joint Diseases
Musculoskeletal Diseases