Management of SpondylodiscitisCors'aimeNCT06489977
Rigid Corset Immobilisation of Patients Suffering From Spondylodiscitis: Practice Assessment
An observational study of Management of Spondylodiscitis, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Our study is a survey of the current management of patients suffering from spondylodiscitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Management of Spondylodiscitis
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2024to 30 Nov 2024
- 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
- Adult, Older adult
Study population: Medical and paramedical staff working in facilities providing care for patients hospitalised with spondylodiscitis will be asked to complete a questionnaire assessing their day-to-day practices. Patients who have been hospitalised for spondylodiscitis in the Infectious Diseases and Rheumatology Departments at Clermont-Ferrand University Hospital during the last 4 years will receive the information note. After a period of one month, if they have not expressed their opposition, they will be contacted by telephone to take part in a semi-structured interview lasting 15 to 20 minutes to find out about their experience of care and their satisfaction.
Who may be able to join
- For patients:
- Patients aged over 18,
- Patients hospitalised at Clermont-Ferrand University Hospital with infectious spondylodiscitis,
- Patient willing to be interviewed.
- For care workers:
- Doctors, nurses or care assistants involved in the care of patients hospitalised with spondylodiscitis.
Who cannot join
- For patients :
- Minor patients,
- Patients wearing a corset for a non-infectious spinal pathology,
- Patient refusing to take part in the study.
- For care workers:
- Doctor, nurse or nursing auxiliary refusing to take part in the study.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Clermont Ferrand
Clermont-Ferrand, 63000
Delphine MARTINEAU, Mrs, +33473754992, dportalmartineau@chu-clermontferrand.fr
Eman BA HARETHA, Mrs, +33473754992, ebaharetha@chu-clermontferrand.fr
About this study
Our study is a survey of the current management of patients suffering from spondylodiscitis.
Read the detailed description
Our main objective was to describe the use of rigid corsets to immobilise patients with spondylodiscitis in hospital, by asking doctors about their practices.
The secondary objectives are :
- To describe the use of rigid corsets to immobilise patients suffering from spondylodiscitis in hospital by asking paramedical staff about the way in which medical prescriptions were implemented and patients about their compliance.
- To measure the rate of satisfaction and understanding of patients treated with a corset.
- To detail the different ways in which doctors and paramedical staff manage patients hospitalised for spondylodiscitis, depending on their age, training, speciality and the department in which they work.
- Conditions
- Management of Spondylodiscitis
- Keywords
- spondylodiscitis, corset, spinal infection, vertebral disc, spinal bodies, practical assessment
- Medical subject headings
- Discitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician survey to identify medical practices in the management of patients suffering from spondylodiscitis in hospital.
Questionnaire to evaluate medical practices
Measured: 3 months
Secondary outcomes (2)
Practical application of rigid corset prescriptions by paramedical teams.
Questionnaire to evaluate paramedical practices
Measured: 3 months
Patient compliance, feedback, understanding and satisfaction with wearing the corset
Questionnaire to assess patient compliance and feelings
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start1 Jul 2024 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Management of SpondylodiscitisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurore MIGNE, Principal investigator, University Hospital, Clermont-FerrandOrlane MENAGE, Principal investigator, University Hospital, Clermont-FerrandClémence RICHAUD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489977
- Sponsor's protocol ID
- M24RC0512
- Acronym
- Cors'aime
- Status last verified
- Jun 2024
- First submitted
- 24 Jun 2024
- Last updated
- 8 Jul 2024
- 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 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rigid Corset Immobilisation of Patients Suffering From Spondylodiscitis: Practice Assessment
- ClinicalTrials.gov ID
- NCT06489977
- Acronym / sponsor ID
- Cors'aime / M24RC0512
- Conditions
- Management of Spondylodiscitis
- Keywords
- spondylodiscitis, corset, spinal infection, vertebral disc, spinal bodies, practical assessment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 8 Jul 2024 (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.
Our study is a survey of the current management of patients suffering from spondylodiscitis.
Detailed description
Our main objective was to describe the use of rigid corsets to immobilise patients with spondylodiscitis in hospital, by asking doctors about their practices.
The secondary objectives are :
- To describe the use of rigid corsets to immobilise patients suffering from spondylodiscitis in hospital by asking paramedical staff about the way in which medical prescriptions were implemented and patients about their compliance.
- To measure the rate of satisfaction and understanding of patients treated with a corset.
- To detail the different ways in which doctors and paramedical staff manage patients hospitalised for spondylodiscitis, depending on their age, training, speciality and the department in which they work.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Medical and paramedical staff working in facilities providing care for patients hospitalised with spondylodiscitis will be asked to complete a questionnaire assessing their day-to-day practices. Patients who have been hospitalised for spondylodiscitis in the Infectious Diseases and Rheumatology Departments at Clermont-Ferrand University Hospital during the last 4 years will receive the information note. After a period of one month, if they have not expressed their opposition, they will be contacted by telephone to take part in a semi-structured interview lasting 15 to 20 minutes to find out about their experience of care and their satisfaction.
Key inclusion criteria (6 listed)
- Patients aged over 18,
- Patients hospitalised at Clermont-Ferrand University Hospital with infectious spondylodiscitis,
- Patient willing to be interviewed.
- Doctors, nurses or care assistants involved in the care of patients hospitalised with spondylodiscitis.
Key exclusion criteria (6 listed)
- Minor patients,
- Patients wearing a corset for a non-infectious spinal pathology,
- Patient refusing to take part in the study.
- Doctor, nurse or nursing auxiliary refusing to take part in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physician survey to identify medical practices in the management of patients suffering from spondylodiscitis in hospital.
Time frame: 3 months
Questionnaire to evaluate medical practices
2 secondary outcomes
Practical application of rigid corset prescriptions by paramedical teams.
Time frame: 3 months
Patient compliance, feedback, understanding and satisfaction with wearing the corset
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
Related trials for Management of Spondylodiscitis
Not yet recruitingObservational study
One Year Results of Managing Primary Spondylodiscitis
Primary Spondylodiscitis, Pyogenic Spondylodiscitis
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.
Aurore MIGNE principal investigator
University Hospital, Clermont-Ferrand
Orlane MENAGE principal investigator
University Hospital, Clermont-Ferrand
Clémence RICHAUD principal investigator
University Hospital, Clermont-Ferrand
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 Management of Spondylodiscitis, run by University Hospital, Clermont-Ferrand 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 8 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician survey to identify medical practices in the management of patients suffering from spondylodiscitis in hospital. (time frame: 3 months). 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 8 Jul 2024.