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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Prosthetic Joint Infection
• Intervention / Treatment: Other: Quality of life

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Tristan FERRY, MD, PhD; Phone Number: +33 04 72 07 11 07; Email: tristan.ferry@chu-lyon.fr
• Study Contact Backup: Name: Eugénie MABRUT; Phone Number: +33 04 26 73 29 38; Email: eugenie.mabrut@chu-lyon.fr

Study Locations

• France
  • Lyon, France, 69004
    • Recruiting
    • Centre de reference des infections ostéo-articulaires de Lyon
    • Contact: Tristan FERRY, MD, PhD; Phone Number: +33 04 72 07 11 07; Email: tristan.ferry@chu-lyon.fr
    • Contact: Eugénie MABRUT; Phone Number: +33 04 26 73 29 38; Email: eugenie.mabrut@chu-lyon.fr
    • Principal Investigator: Tristan FERRY, MD, PhD
    • Sub-Investigator: Sebastien LUSTIG, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients having an prosthetic joint infection

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Analog Visual Scale	Use of a Analog Visual Scale to measure the quality of life	12 to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2017
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: October 4, 2017
• First Submitted That Met QC Criteria: October 10, 2017
• First Posted (Actual): October 11, 2017

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Joint Diseases; Musculoskeletal Diseases; Arthritis; Infections; Communicable Diseases; Arthritis, Infectious
• Other Study ID Numbers: 69HCL17_0419

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No