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
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|
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|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|
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.
- 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.
- Analog Visual Scale [ Time Frame: 12 months ]Use of a Analog Visual Scale to measure the quality of life
- 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.
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
|Contact: Tristan FERRY, MD, PhD||04 72 07 11 07 ext +email@example.com|
|Contact: Eugénie MABRUT||04 26 73 29 38 ext +firstname.lastname@example.org|
|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 email@example.com|
|Contact: Eugénie MABRUT 04 26 73 29 38 ext +33 firstname.lastname@example.org|
|Principal Investigator: Tristan FERRY, MD, PhD|