Rigid Corset Immobilisation of Patients Suffering From Spondylodiscitis: Practice Assessment (Cors'aime)

June 28, 2024 updated by: University Hospital, Clermont-Ferrand
Our study is a survey of the current management of patients suffering from spondylodiscitis.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Practical application of rigid corset prescriptions by paramedical teams.
Time Frame: 3 months
Questionnaire to evaluate paramedical practices
3 months
Patient compliance, feedback, understanding and satisfaction with wearing the corset
Time Frame: 3 months
Questionnaire to assess patient compliance and feelings
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Aurore MIGNE, University Hospital, Clermont-Ferrand
  • Principal Investigator: Orlane MENAGE, University Hospital, Clermont-Ferrand
  • Principal Investigator: Clémence RICHAUD, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

June 24, 2024

First Submitted That Met QC Criteria

June 28, 2024

First Posted (Actual)

July 8, 2024

Study Record Updates

Last Update Posted (Actual)

July 8, 2024

Last Update Submitted That Met QC Criteria

June 28, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M24RC0512

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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