ClinicalTrials.gg
Status unknownNCT06489977Cors'aimeUpdated Jul 8, 2024

Rigid Corset Immobilisation of Patients Suffering From Spondylodiscitis: Practice Assessment

An observational study in Management of Spondylodiscitis, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-08.

Sponsored by University Hospital, Clermont-Ferrand · Observational

The sponsor has not verified this record recently (last verified Jun 2024), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

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.
02

Conditions studied

  • Management of Spondylodiscitis

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Keywords

  • spondylodiscitis
  • corset
  • spinal infection
  • vertebral disc
  • spinal bodies
  • practical assessment
03

In context

Discitis

23 studies on the registry are indexed under Discitis; 4 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 16 observational studies indexed under Discitis.

Browse Discitis studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 854 studies on the registry; 180 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Physician survey to identify medical practices in the management of patients suffering from spondylodiscitis in hospital.

    Questionnaire to evaluate medical practices

    Time frame: 3 months

Secondary outcomes

  1. Practical application of rigid corset prescriptions by paramedical teams.

    Questionnaire to evaluate paramedical practices

    Time frame: 3 months

  2. Patient compliance, feedback, understanding and satisfaction with wearing the corset

    Questionnaire to assess patient compliance and feelings

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jul 2024; primary completion for Sep 2024, 2 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 24, 2024
First posted
Jul 8, 2024
StartEst.
Jul 1, 2024
Primary completionEst.
Sep 30, 2024
CompletionEst.
Nov 30, 2024
Last update
Jul 8, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06489977
Responsible party
Sponsor
First posted
Jul 8, 2024
Start date
Jul 1, 2024 (estimated)
Primary completion
Sep 30, 2024 (estimated)
Completion
Nov 30, 2024 (estimated)
Last update
Jul 8, 2024

Study contacts

Lise LACLAUTRE
Contact
promo_interne_drci@chu-clermontferrand.fr
334.73.754.963
Aurore MIGNE
principal investigator · University Hospital, Clermont-Ferrand
Orlane MENAGE
principal investigator · University Hospital, Clermont-Ferrand
Clémence RICHAUD
principal investigator · University Hospital, Clermont-Ferrand

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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