Quality of Life in Patients Having a Prosthetic Joint Infection

Quality of Life Clinical Trial

— QuaVIPA  

Official title:

Quality of Life in Patients Having a Prosthetic Joint Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03307109
• Other study ID #: 69HCL17_0419
• Status: Recruiting
• Start date: October 17, 2017
• Est. completion date: October 2028

Study information

• Verified date: October 2023
• Source: Hospices Civils de Lyon
• Contact: Tristan FERRY, MD, PhD
• Phone: 04 72 07 11 07
• Email: tristan.ferry[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: October 2028
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Infectious
• Communicable Diseases
• Infections
• Prosthetic Joint Infection
• Quality of Life

Intervention

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.

Locations

Country	Name	City	State
France	Centre de reference des infections ostéo-articulaires de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 to 24 months
Primary	Analog Visual Scale	Use of a Analog Visual Scale to measure the quality of life	12 to 24 months
Secondary	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.	12 to 24 months