RecruitingNAINTERVENTIONAL

Developmental Dysplasia of the Hip: Observation vs. Bracing

This study is about a common baby hip problem called developmental dysplasia of the hip (DDH). Usually, babies with DDH are treated with a special brace. However, for those with mild DDH, some experts believe their hips might get better on their own without a brace as they grow. This research wants to find out if simply monitoring these babies very carefully is as effective as using a brace. The goal is to see if we can avoid unnecessary bracing, which can be tricky for parents, especially new mothers, and affect daily life. This study is happening in many hospitals across different countries, meaning the results could help many families worldwide.

At a glance

Status

Recruiting

Phase

Sponsor

University of British Columbia

Enrolment target

514

Start

25 Apr 2024

Estimated completion

01 Sep 2028

Developmental Dysplasia of the Hip Hip Dysplasia Hip Dysplasia, Congenital Hip Dysplasia, Developmental

What is this study about?

Developmental dysplasia of the hip (DDH) is a common condition where a baby's hip joint hasn't formed properly. It's often found early in life. Traditionally, if a baby is diagnosed with DDH, even a mild form, they are treated with a special brace called a Pavlik harness for several weeks. While this brace can help the hip develop correctly, it can also be challenging for new parents. It can make things like bathing, changing nappies, and even cuddling a bit more difficult, and some parents worry it can affect the special bonding time with their new baby.

However, some doctors think that for babies with very mild DDH, their hips might actually get better on their own as they grow and develop, without needing a brace at all. The aim of this study is to explore this idea. Researchers want to compare two groups of babies with mild DDH: one group will wear a brace, and the other will be carefully monitored to see if their hips improve naturally. By doing this, they hope to discover if careful monitoring can be a safe and effective option, potentially helping many babies avoid wearing a brace.

This is an important study because it's the first of its kind to involve hospitals in many different countries. The results could change how doctors treat babies with mild DDH, making treatment choices easier and less stressful for families around the world. It’s all about finding the best and kindest way to help babies with this condition.

Key takeaways

This study focuses on mild hip dysplasia in babies under 3 months.
It compares watching closely to using a brace for treatment.
The goal is to see if some babies can avoid a brace.
Results could help families globally by guiding treatment decisions.
The study is international, involving many hospitals.
Participation carefully considers the impact on babies and families.

Who may be eligible?

This study is looking for very specific babies to take part. Your baby might be eligible if they are under three months old (up to 12 weeks of age) and have been diagnosed with mild hip dysplasia. This diagnosis is made after an ultrasound scan of their hip. The scan needs to show that the hip joint is in the correct place, but the angle and coverage measures meet the criteria for mild dysplasia.

Your baby would not be able to join the study if they are older than three months when diagnosed with hip dysplasia, or if a doctor feels their hip is unstable (meaning it can easily pop out of place). Also, babies with other known health conditions affecting their muscles, bones, or genes, or those who have already had treatment for hip dysplasia (like a Pavlik harness), would not be able to participate. The study is open to both baby boys and girls.

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.

Is my baby under 12 weeks old (3 months)?
Has my baby been diagnosed with mild hip dysplasia after an ultrasound?
Is my baby's hip generally stable (not easily popping out)?
Does my baby have any other significant health conditions, especially affecting their bones or muscles?
Has my baby ever had treatment for hip dysplasia before (like a Pavlik harness)?

Answer every question to see your result.

What does participation involve?

The information provided does not detail the exact participation requirements, such as the number of hospital visits, specific assessments, or the total duration of the study. It mentions a comparison between bracing and careful monitoring. If your baby is in the monitoring group, it would likely involve regular ultrasound scans to check on their hip development. If in the bracing group, the Pavlik harness would typically be worn for about six weeks. You would also have check-up appointments to ensure the brace is fitted correctly and to monitor your baby's progress. Please speak to your doctor for full details on what taking part involves.

Potential risks and benefits

Taking part in this study could potentially benefit your baby by helping us understand if some cases of mild hip dysplasia can improve without a brace, possibly avoiding the challenges that come with brace treatment. However, there are also potential risks, as we are still learning which approach is best for mild cases. If your baby is in the monitoring group, there's a small chance their hip might not improve on its own and may require a brace later. If in the bracing group, the known difficulties of brace treatment apply. You will be given full information about any potential risks and benefits before making a decision, and remember, you have the right to withdraw your baby from the study at any time without affecting their medical care.

Locations (1)

BC Children's Hospital
Verified postcode
Vancouver, Canada· Recruiting

Common questions

What is Developmental Dysplasia of the Hip (DDH)?

It's a common condition in babies where the hip joint hasn't developed normally. This means the top of the thigh bone doesn't sit snugly in the hip socket.

What is a Pavlik harness?

It's a soft brace that holds a baby's hips and knees bent and apart. This position encourages the hip joint to develop properly.

Why are doctors comparing bracing to watching and waiting?

Doctors want to see if for very mild cases of DDH, babies' hips can get better on their own, potentially allowing them to avoid wearing a brace and the difficulties that come with it.

Can my baby take part if they are older than 3 months?

No, this study is specifically for babies diagnosed with mild DDH who are under 3 months (12 weeks) old.

What does 'unnecessary treatment' mean in this context?

It refers to treatment (like wearing a brace) that might not be needed if a baby's hip can improve naturally without it.

How to find out more

Emily Schaeffer, PhD

emily.schaeffer@cw.bc.ca 604-875-2359 Official trial record

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