RecruitingNAINTERVENTIONAL

Evaluation of the Evolution of Patient Care Within the Spinal Pathology Department

This study, taking place in a hospital in Bordeaux, France, aims to understand how patient care for various spine conditions is developing over five years. Doctors want to see how new surgical methods and medical devices are affecting how they treat problems like spinal stenosis, spinal fractures, and infections or tumours of the spine. They will collect detailed information from patients about their health, why they came to the hospital, and the specific spine treatment they received. This will help them understand if these newer, constantly improving treatments are making a difference in patient care over time. The study doesn't involve any new treatments, just observing current practices.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Bordeaux

Enrolment target

15,000

Start

25 May 2023

Estimated completion

01 Aug 2031

Spinal Stenosis SPINAL Fracture Vertebral Osteomyelitis Vertebral Metastasis

What is this study about?

This important study is looking at how doctors are treating different spine problems, such as wear and tear on the spine, fractures (broken bones), infections, and even tumours. Spine conditions can cause a lot of health issues for many people.

Over the years, treatments for spine problems, especially surgery, have hugely improved. There are always new ways to operate and new devices that doctors can use. However, it's not always clear how these new methods are actually changing how patients are cared for in the real world. This study aims to fill that gap.

By carefully collecting information from a large number of patients over five years, doctors hope to get a clear picture of how spine care is evolving. They want to see how often different treatments are used and if these changes are improving patient experiences and outcomes. It’s like taking a long-term look at how things are done to make sure progress is truly benefiting patients.

Key takeaways

This study observes and collects information, not new treatments.
It aims to understand how spine care is changing over time.
Participants will fill out questionnaires about their health.
The study includes various common and urgent spine conditions.
Your medical care will not be affected if you choose to participate or not.
Data will be collected over five years, with three-year patient follow-ups.

Who may be eligible?

To be part of this study, you need to be at least 18 years old. If you're under 18 but old enough to understand and agree to have your information collected, you could potentially join with permission from your parent or guardian. You must be visiting the spine surgery department of the University Hospital of Bordeaux in France for a spine problem.

This includes common issues like wear and tear in your neck or back, problems with your spine's shape, or urgent issues like a spinal fracture, infection, or tumour. The study is open to everyone, regardless of gender.

There are a few reasons someone might not be able to join. For example, if you are legally unable to make decisions for yourself, like someone under guardianship, or if you can't give your clear permission to take part, you wouldn't be able to join. Also, you need to be part of France's health insurance system.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you receiving treatment for a spine condition at the University Hospital of Bordeaux, France?
Can you understand and agree to your information being collected?
Are you part of the French social protection (health insurance) system?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you won't be given any new drugs or treatments. The study is simply observing and collecting information about the care you're already receiving for your spine condition. You'll be asked to fill out some questionnaires about your health and how your spine problem affects your daily life. This is something you'll fill out yourself.

Researchers will also gather information from your medical records, including details about your general health, why you came to the hospital, and the specific spine condition you have. They'll also record the treatments you receive. After your initial care, the team plans to follow up with you for three years to see how things are progressing. The total duration of data collection for the study is five years, but your individual follow-up will be for three years.

Potential risks and benefits

There are no direct risks from taking part in this study, as it only involves collecting information about your existing care and doesn't change your treatment. The main benefit is that the information gathered will help doctors better understand how spine care is changing and improving. This could lead to better treatment methods for future patients with similar conditions. You are always free to decide not to participate or to withdraw your information at any time, without it affecting your medical care.

Locations (1)

Hôpital Pellegrin, Centre Hospitalier Universitaire de Bordeaux
Verified postcode
Bordeaux, France· Recruiting

Common questions

What kind of spine problems are included?

It includes problems like general wear and tear in your back or neck, changes in your spine's shape, and urgent issues like fractures, infections, or tumours.

Do I have to take any new medicine or treatment?

No, this study only watches and records how you're already being treated. It doesn't involve any new medicines or treatments.

How long will I be involved?

You'll be followed for three years after your initial care at the hospital.

Where is this study happening?

It's happening in the spine surgery department at the University Hospital of Bordeaux in France.

Can I change my mind about taking part?

Yes, you can decide not to participate or withdraw your information at any time without it affecting your medical care.

How to find out more

Benjamin BOUYER, PROF

b.bouyer@chu-bordeaux.fr +335 56 79 87 18 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.