RecruitingOBSERVATIONAL

Evaluation of the Long-term Outcome of Dorsal Ligamentoplasty Reinforced With an Internal Brace in the Treatment of Scapholunate Instability

This study is a long-term look at people in the UK who have had a specific type of wrist surgery. The surgery is called dorsal ligamentoplasty, helped by something called an internal brace. It's performed to treat a wrist condition known as scapholunate instability, where the bones in your wrist are not as stable as they should be. Researchers want to see how patients are doing five years after their operation. They are carefully watching a group of patients to understand the lasting effects and success of this treatment. The aim is to learn more about how well this surgery helps people with wrist problems in the long run.

At a glance

Status

Recruiting

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Enrolment target

Start

24 Apr 2024

Estimated completion

01 May 2031

Wrist Disease

What is this study about?

Imagine your wrist is like a finely tuned machine, with many small bones working together. Sometimes, a key connection between two wrist bones, called the scaphoid and lunate, can become loose or unstable. This is known as scapholunate instability and can cause pain, weakness, and difficulty moving your wrist.

Doctors have different ways to treat this, and one method is a special operation called dorsal ligamentoplasty, often combined with an "internal brace." This surgery aims to repair and strengthen the stretched or torn ligaments that hold these bones together. Think of the internal brace as an extra support to help the repair heal properly and make your wrist more stable.

This study, conducted across several hospitals, is designed to carefully follow patients who have had this particular wrist surgery. The main goal is to understand how well the surgery works over a long period, specifically five years. By tracking these patients, doctors hope to learn if the surgery successfully reduces pain, improves wrist function, and if the benefits last. This information is really important because it helps doctors decide the best way to help other people with similar wrist problems in the future.

Key takeaways

This study observes people who've had specific wrist surgery for scapholunate instability.
It aims to see how well the surgery works over five years.
No new treatments or medicines are given as part of the study.
Your normal follow-up appointments provide the study's information.
Participation helps improve understanding of wrist surgery outcomes for future patients.
You can stop taking part at any time without affecting your NHS care.

Who may be eligible?

To be included in this study, you must be 18 years old or older. You also need to have already gone through the specific wrist operation called dorsal ligamentoplasty, which was reinforced with an internal brace, to treat scapholunate instability. It's important that you understand what the study involves and agree for your information to be used.

There are certain reasons why someone might not be able to join the study. If you have a condition that makes it difficult to understand instructions or follow the study plan, you wouldn't be able to participate. Also, if you are under legal protection because you're unable to make decisions for yourself, you wouldn't be eligible. The study is open to both men and women.

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?
Have you had dorsal ligamentoplasty reinforced with an internal brace for scapholunate instability?
Do you understand what the study involves?
Are you happy for your medical information to be used for research?
Do you feel able to follow instructions and attend your regular check-ups?
Are you able to make your own medical decisions?

Answer every question to see your result.

What does participation involve?

If you join this study, you won't need to have any new treatments or take any new medications just for the study. The study simply involves the research team keeping track of your health and wrist condition after you've had your surgery. You will already be having follow-up appointments with your surgeon as part of your standard care. The researchers will gather information from these appointments over five years, starting from when you left the hospital after your operation. There are no extra hospital visits specifically for the study. The total duration of your involvement in this study, purely for observation, will be five years.

Potential risks and benefits

The main benefit of taking part is helping doctors and other patients. By sharing your experience, you contribute to a better understanding of how well this wrist surgery works in the long term, which can improve future care for others. As this is an observational study, there are no additional medical risks from the study itself, as no new treatments are being given. Your medical team will continue to monitor your recovery as part of your usual care. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

Clinique Monticelli - Vélodrome
Verified postcode
Marseille, France· Recruiting

Common questions

What is scapholunate instability?

It's a condition where the connection between two bones in your wrist, called the scaphoid and lunate, is loose, causing pain and problems with movement.

What is dorsal ligamentoplasty with an internal brace?

It's a type of surgery that repairs and strengthens the ligaments connecting your wrist bones, using an extra support called an internal brace.

Do I have to take any new medicine for this study?

No, you won't be given any new medicines or treatments specifically for this study. It's about observing your recovery after surgery.

How long will I be involved in the study?

The researchers will follow your progress for five years after your surgery, using information from your usual check-ups.

Can I leave the study if I change my mind?

Yes, you can decide to stop participating at any point, and it won't affect your medical care.

How to find out more

Aurélie INIESTA, MD

aurelie.iniesta@gmail.com 04 91 16 22 22 Official trial record

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