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NCT Number: NCT03307109

Quality of Life in Patients Having a Prosthetic Joint Infection

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.

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Key information

Conditions

Quality of Life Prosthetic Joint Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre de reference des infections ostéo-articulaires de Lyon

Lyon, 69004, France

Location status: Recruiting

Location contact

Eugénie MABRUT

CONTACT

[email protected]

04 26 73 29 38 ext. +33

Sebastien LUSTIG, MD, PhD

SUB_INVESTIGATOR

Tristan FERRY, MD, PhD

CONTACT

[email protected]

04 72 07 11 07 ext. +33

Tristan FERRY, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quality of life

Other

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 outcomes

  1. Questionnaire EQ-5D-3L

    Time frame: 12 to 24 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 to 24 months

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

Secondary outcomes

  1. Questionnaire EQ-5D-5L

    Time frame: 12 to 24 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Eugénie MABRUT

CONTACT

[email protected]

04 26 73 29 38 ext. +33

Tristan FERRY, MD, PhD

CONTACT

[email protected]

04 72 07 11 07 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: QuaVIPA

Important dates

Study start
2017
Primary completion
2026
Study completion
2028
First posted
Oct 11, 2017
Registry last updated
Oct 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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