RecruitingOBSERVATIONAL

Muscle Connective Tissue in Limb Development and Disease

This study aims to understand what causes changes in the muscles and soft tissues in children born with radial dysplasia, a condition that affects how their arms and hands develop. Even with surgery, these problems often return as the child grows, making it an 'unsolved problem'. Researchers believe the issue might be linked to the connective tissue within the muscles. They will collect small tissue samples during planned hand surgeries from children with radial dysplasia and from others having surgery for hand injuries. By comparing these samples, they hope to learn more about normal limb development and what goes wrong in radial dysplasia. The goal is to use this new knowledge to improve treatments, making them more effective and lasting for affected children.

At a glance

Status

Recruiting

Sponsor

King's College London

Enrolment target

150

Start

20 Feb 2016

Estimated completion

01 Aug 2036

Radial Dysplasia

What is this study about?

Imagine the muscles in our arms and hands. They are surrounded by special stretchy tissue called connective tissue, which helps them work properly. In this study, doctors are trying to understand why children born with a condition called radial dysplasia have problems with their arms and hands. Radial dysplasia causes the arm and hand to develop differently, often affecting how well they can move.

Even though there are good surgeries to help with radial dysplasia, sometimes the problems come back as the child gets older. This means we don't fully understand what causes these long-term issues. Researchers have a hunch that the connective tissue in the muscles might be playing a big part. They've seen something similar in special mouse studies.

So, the main goal of this study is to look closely at these muscle connective tissues. By comparing samples from children with radial dysplasia to samples from children who are having hand surgery for other reasons (like an injury), they hope to discover exactly what's different. This new information could help doctors develop much better treatments that last, making a real difference for children with radial dysplasia.

Key takeaways

Aims to understand arm/hand development in radial dysplasia.
Investigates little-understood connective tissues in muscles.
Small tissue sample taken during existing, planned surgery.
No extra procedures or changes to your child's medical care.
Results could lead to better treatments for future patients.

Who may be eligible?

This study is looking for two main groups of people. The first group includes children of any age who have been diagnosed with radial dysplasia and need surgery to help with their arm or hand. Their parents would need to give permission for them to take part.

The second group acts as a comparison and includes children of any age who need hand surgery for other reasons, like an injury. Again, their parents would need to agree for them to participate. Both boys and girls can take part.

However, some children won’t be able to join. This includes those with radial dysplasia who don't need surgery, or anyone with other conditions that aren't radial dysplasia. Also, if a child has a lot of scarring on their forearm or hand already, or a specific skin problem where the sample would be taken, they might not be able to participate.

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.

Has my child been diagnosed with radial dysplasia?
Does my child need surgery for their radial dysplasia?
Is my child having hand surgery for an injury or other reason (if not radial dysplasia)?
Does my child have a lot of scarring on their forearm/hand already?
Does my child have any significant skin issues where a sample would be taken?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the main thing involved is allowing doctors to collect a very small piece of tissue. This will happen during an operation your child is already having on their hand or arm. This means your child won't need an extra separate procedure just for the study. The surgeons will simply take the tiny sample during the planned surgery, without changing any of the care or treatments they would normally receive. There are no extra visits or medications involved specifically for this study. After the tissue sample is taken during the operation, your child's part in the study is complete, and the researchers will then study the samples in their lab.

Potential risks and benefits

There are no direct personal benefits to your child from taking part in this study, but the information gained could greatly help future children with radial dysplasia by leading to better treatments. The main risk is very small, as the tissue sample is taken during an operation your child is already having, using existing surgical incisions. This means there's no additional scar or changes to their planned treatment. You are free to withdraw your child from the study at any time without giving a reason, and this will not affect their medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Oxford University Hospitals
Verified postcode
Oxford, United Kingdom· Recruiting
Royal Free Hospital
Verified postcode
London, United Kingdom· Recruiting
Guy's and St Thomas' Hospital
Verified postcode
London, United Kingdom· Recruiting
Chelsea and Westminster Hospital NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting
Great Ormond Street Hospital for Children NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is radial dysplasia?

Radial dysplasia is a condition where a child's arm and hand don't develop typically, often affecting how well they can use their hand and wrist.

Will my child need an extra operation for this study?

No, the small tissue sample will be collected during an operation your child is already scheduled to have on their hand or arm.

Will taking part change my child's surgery or recovery?

No, the study won't change your child's planned surgery, the scar, or their recovery in any way.

What will researchers do with the tissue samples?

Researchers will look closely at the samples in a lab to understand the tiny building blocks of the tissue and how they work, comparing healthy tissue to tissue from children with radial dysplasia.

Is this study meant to help my child directly?

No, this study is to help doctors learn more about radial dysplasia generally, so they can develop better treatments for children in the future, rather than directly treating your child's condition.

How to find out more

Malcolm Logan, BSc PhD

malcolm.logan@kcl.ac.uk 02078486886 Official trial record

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