Quality of LifeQuaVIPANCT03307109
Quality of Life in Patients Having a Prosthetic Joint Infection
An observational study of Quality of Life and Prosthetic Joint Infection, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Prosthetic Joint Infection
- What is being tested?
- Quality of life
- How many people
- 154 participants
- Where
- 1 siteFrance
- Study dates
- 17 Oct 2017to 3 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients having an prosthetic joint infection
Who may be able to join
- Patient having prosthetic joint infection
- Patient who did not object to participate in the study
- Patients over 18 years of age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de reference des infections ostéo-articulaires de Lyon
Lyon, 69004
About this study
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.
Read more
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.
- Conditions
- Quality of Life, Prosthetic Joint Infection
- Being tested
- Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of lifeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 to 24 months
Analog Visual Scale
Use of a Analog Visual Scale to measure the quality of life
Measured: 12 to 24 months
Secondary outcomes (1)
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.
Measured: 12 to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start17 Oct 2017
- Primary completion3 Mar 2026
- Study completion3 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03307109
- Sponsor's protocol ID
- 69HCL17_0419
- Acronym
- QuaVIPA
- Status last verified
- Sep 2026
- First submitted
- 4 Oct 2017
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in Patients Having a Prosthetic Joint Infection
- ClinicalTrials.gov ID
- NCT03307109
- Acronym / sponsor ID
- QuaVIPA / 69HCL17_0419
- Conditions
- Quality of Life, Prosthetic Joint Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 3 Mar 2026 (actual)
- Study completion
- 3 Mar 2026 (actual)
- First posted
- 11 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients having prosthetic joint infection | – | Other: Quality of lifeThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having an prosthetic joint infection
Key inclusion criteria (3 listed)
- Patient having prosthetic joint infection
- Patient who did not object to participate in the study
- Patients over 18 years of age
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of lifePatients 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. | Other | Patients having prosthetic joint infection |
Primary outcome
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.
Analog Visual Scale
Time frame: 12 to 24 months
Use of a Analog Visual Scale to measure the quality of life
1 secondary outcome
Questionnaire EQ-5D-5L
Time frame: 12 to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Prosthetic Joint Infection, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire EQ-5D-3L (time frame: 12 to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.