Complications; Implant, Orthopedic, Infection or InflammationOPWAINCT05284331
Outcome of Old Patient With Articular With Articular Implant Infection
A study testing addition of two follow-up visits post infection in people with Complications; Implant, Orthopedic, Infection or Inflammation, run by Centre Hospitalier Metropole Savoie at 1 site in France.
Trial summary
Articular Implant Infection (AII) is itself a complicated diagnosis and a challenging condition to treat. In elderly patients, the application of existing recommendations is impeded by multiple frailties For a better knowledge of the long-term consequences of AII in elderly patient, the investigators conduct a… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Complications; Implant, Orthopedic, Infection or Inflammation
- What is being tested?
- addition of two follow-up visits post infection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 3 Mar 2021to 28 Mar 2023
- Phase
- Interventional
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- hospitalized in infectious diseases, surgery, post-emergency unit, or geriatrics,
- diagnosed with a hip or knee prosthesis infection in the previous month according to the SPILF criteria (2009)(1).
Who cannot join
- Above criteria not met,
- Patient refusal,
- Mild cognitive impairment or more significant.
Trial locations and contacts
1 site in 1 country.
About this study
Articular Implant Infection (AII) is itself a complicated diagnosis and a challenging condition to treat. In elderly patients, the application of existing recommendations is impeded by multiple frailties For a better knowledge of the long-term consequences of AII in elderly patient, the investigators conduct a prospective, multicentric study, whitch aim this is to better evaluate the burden of AII on elderly patients, in terms of quality of life. Secondly, the investigators would like to identify the factors that influence the prognosis, in order to guide further prospective research.
Read the detailed description
Articular Implant Infection (AII) is itself a complicated diagnosis (diagnosis confirmation, pathogen identification, with appropriate samples) and a challenging condition to treat (long antibiotic exposure, repeated surgery, complex implant change). This condition requires a good cooperation between surgeon and infectious disease specialist, with a comprehension of each one's constraint. In elderly patients, the application of existing recommendations is impeded by multiple frailties (malnutrition, loss of autonomy, polypathology) which make each decision crucial. Indeed, from the choice of surgery to antibiotics management, all medical decision can induce more adverse events than in younger patients. For a better knowledge of the long-term consequences of AII in elderly patient, the investigators conduct a prospective, multicentric study, based on the evaluation of the EQ-5D-5L score during one year after AAI diagnosis in patients older than 75. The investigators evaluate this score and compare different groups of patients, according to age, nutrition status, Charlson comorbidity index, hospital stay length, and loss of autonomy, among others. The aim of this study is to better evaluate the burden of AII on elderly patients, in terms of quality of life. Secondly, the investigators would like to identify the factors that influence the prognosis, in order to guide further prospective research.
- Being tested
- addition of two follow-up visits post infection
- Keywords
- Articular Implant Infection
- Medical subject headings
- Infections, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
addition of two follow-up visits post infectionOther
Addition of an additional follow-up visit 6 months post infection and one follow-up visit 1 year post infection.
No treatment will be given specifically for this study. The change in medical management will only be modified by the addition of these 2 consultations at 6 months and 1 year post infection
| Study group | Role | What they receive |
|---|---|---|
| follow-up visit at 6 months and 1 year after inclusion. | Other | addition of a follow-up visit at 6 months and 1 year after inclusion. No treatment will be given specifically for this study. Other visits are part of the normal and usual rhythm of follow-up and evaluation of treatment in these patients Receives: Other: addition of two follow-up visits post infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the EQ-5D-5L quality of life score
the EQ-5D-5L questionnaire is a European quality of life scale: a first part with questions called "EQ-5D descriptive system" comprising 5 items: mobility, self-care, usual activities, pain and discomfort, anxiety and depression; each item is rated from 1 to 5; 1 corresponding to "no problem", "5" representing "extreme problems or total disability Changes in the EQ-5D-5L quality of life score, 1 year after the onset of symptoms will be evaluated
Measured: 1 year
Changes in the EQ-5D-VAS assessing the patient's general condition, completed by the patient
the EQ-5D-5L questionnaire is completed by a visual analogue scale, called "EQ-5D VAS"; it consists of a 20 cm line, graduated from 0 to 100, where the patient has to indicate how he/she evaluates his/her current state of health, 0 being the worst possible state and 100 the best; Changes in the "EQ-5D VAS" wil be evaluated 1 year after the onset of symptoms.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start3 Mar 2021
- Primary completion28 Mar 2023
- Study completion28 Mar 2023
Why it stopped: lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications; Implant, Orthopedic, Infection or InflammationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Metropole Savoie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PEJU Martin, Physician, Principal investigator, Centre Hospitalier Metropole Savoie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284331
- Sponsor's protocol ID
- CHMS20001
- Acronym
- OPWAI
- Status last verified
- Mar 2023
- First submitted
- 24 Sep 2021
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Old Patient With Articular With Articular Implant Infection
- ClinicalTrials.gov ID
- NCT05284331
- Acronym / sponsor ID
- OPWAI / CHMS20001
- Keywords
- Articular Implant Infection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Centre Hospitalier Metropole SavoieUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 17 Mar 2022 (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.
Articular Implant Infection (AII) is itself a complicated diagnosis and a challenging condition to treat. In elderly patients, the application of existing recommendations is impeded by multiple frailties For a better knowledge of the long-term consequences of AII in elderly patient, the investigators conduct a prospective, multicentric study, whitch aim this is to better evaluate the burden of AII on elderly patients, in terms of quality of life. Secondly, the investigators would like to identify the factors that influence the prognosis, in order to guide further prospective research.
Detailed description
Articular Implant Infection (AII) is itself a complicated diagnosis (diagnosis confirmation, pathogen identification, with appropriate samples) and a challenging condition to treat (long antibiotic exposure, repeated surgery, complex implant change). This condition requires a good cooperation between surgeon and infectious disease specialist, with a comprehension of each one's constraint. In elderly patients, the application of existing recommendations is impeded by multiple frailties (malnutrition, loss of autonomy, polypathology) which make each decision crucial. Indeed, from the choice of surgery to antibiotics management, all medical decision can induce more adverse events than in younger patients. For a better knowledge of the long-term consequences of AII in elderly patient, the investigators conduct a prospective, multicentric study, based on the evaluation of the EQ-5D-5L score during one year after AAI diagnosis in patients older than 75. The investigators evaluate this score and compare different groups of patients, according to age, nutrition status, Charlson comorbidity index, hospital stay length, and loss of autonomy, among others. The aim of this study is to better evaluate the burden of AII on elderly patients, in terms of quality of life. Secondly, the investigators would like to identify the factors that influence the prognosis, in order to guide further prospective research.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| follow-up visit at 6 months and 1 year after inclusion. | Other | Other: addition of two follow-up visits post infectionaddition of a follow-up visit at 6 months and 1 year after inclusion. No treatment will be given specifically for this study. Other visits are part of the normal and usual rhythm of follow-up and evaluation of treatment in these patients |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- hospitalized in infectious diseases, surgery, post-emergency unit, or geriatrics,
- diagnosed with a hip or knee prosthesis infection in the previous month according to the SPILF criteria (2009)(1).
Key exclusion criteria (3 listed)
- Above criteria not met,
- Patient refusal,
- Mild cognitive impairment or more significant.
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 |
|---|---|---|
| addition of two follow-up visits post infectionAddition of an additional follow-up visit 6 months post infection and one follow-up visit 1 year post infection. No treatment will be given specifically for this study. The change in medical management will only be modified by the addition of these 2 consultations at 6 months and 1 year post infection | Other | follow-up visit at 6 months and 1 year after inclusion. |
Primary outcome
Changes in the EQ-5D-5L quality of life score
Time frame: 1 year
the EQ-5D-5L questionnaire is a European quality of life scale: a first part with questions called "EQ-5D descriptive system" comprising 5 items: mobility, self-care, usual activities, pain and discomfort, anxiety and depression; each item is rated from 1 to 5; 1 corresponding to "no problem", "5" representing "extreme problems or total disability Changes in the EQ-5D-5L quality of life score, 1 year after the onset of symptoms will be evaluated
Changes in the EQ-5D-VAS assessing the patient's general condition, completed by the patient
Time frame: 1 year
the EQ-5D-5L questionnaire is completed by a visual analogue scale, called "EQ-5D VAS"; it consists of a 20 cm line, graduated from 0 to 100, where the patient has to indicate how he/she evaluates his/her current state of health, 0 being the worst possible state and 100 the best; Changes in the "EQ-5D VAS" wil be evaluated 1 year after the onset of symptoms.
Results and safety
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
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.
PEJU Martin, Physician principal investigator
Centre Hospitalier Metropole Savoie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing addition of two follow-up visits post infection in people with Complications; Implant, Orthopedic, Infection or Inflammation, run by Centre Hospitalier Metropole Savoie 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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 30 Mar 2023. 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 was stopped early (reason given: lack of recruitment). Results are not available in the source record.
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?
Changes in the EQ-5D-5L quality of life score (time frame: 1 year). 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 30 Mar 2023.