RecruitingNAINTERVENTIONAL

Pavlik Harness Treatment vs Monitoring for Treatment of Developmental Dysplasia of the Hip (DDH) in Babies Diagnosed With Graf Type 2 Hips

This study is about a common hip condition in babies called Developmental Dysplasia of the Hip (DDH). Currently, a soft harness called a Pavlik harness is often used to treat it. However, for certain mild types of hip dysplasia (called Graf type 2b and 2c), we don't know if the harness is always necessary or if the hip might get better naturally. This study aims to find out if there's a difference between using the harness and simply monitoring the baby's hip with regular scans. We want to make sure babies only receive treatment if it's truly needed. If hips don't improve on their own, the harness would be used. The study will look at babies up to 16 weeks old and will last about 15 months for each baby.

At a glance

Status

Recruiting

Phase

Sponsor

Maidstone & Tunbridge Wells NHS Trust

Enrolment target

Start

02 Aug 2023

Estimated completion

01 Jun 2027

Developmental Hip Dysplasia

What is this study about?

When a baby is born, sometimes their hip joint hasn't formed quite right. This is called Developmental Dysplasia of the Hip, or DDH. It's a condition where the top of the thigh bone doesn't sit snugly in the hip socket. If treated early, babies with DDH usually do very well. The standard treatment in the UK often involves using a soft harness called a Pavlik harness, which holds the baby's legs in a position that helps the hip develop correctly.

However, for some specific types of DDH, known as Graf type 2b and 2c, which are milder and the hip is still stable, doctors aren't sure if the harness is always essential. Currently, all babies with these types of hip problems at Maidstone and Tunbridge Wells NHS Trust are given a Pavlik harness to wear for up to 12 weeks. While usually comfortable, wearing the harness can be worrying for parents and can make everyday tasks like bathing and feeding a bit trickier. We want to find out if these milder hip problems might actually improve on their own without the harness.

This study aims to compare two approaches: giving the baby the Pavlik harness as usual, or carefully watching the baby's hip with regular ultrasound scans to see if it gets better by itself. If, during the monitoring, the hip doesn't seem to be improving, the baby would then be given a harness straight away. Because babies would be checked very often, and their hips are stable, we believe there is no risk in trying to see if their hips mature naturally first. The goal is to ensure that babies only receive treatment when it's truly necessary, potentially saving some families the worry and inconvenience of wearing a harness.

Key takeaways

Looks at treating mild hip problems (DDH) in babies.
Compares Pavlik harness treatment with careful monitoring.
Aims to discover if the harness is always necessary for specific mild hip issues.
Babies can join if they are 0-16 weeks old with Graf type 2b or 2c hip dysplasia.
All treatment decisions will prioritise your baby's health.
Results could help improve care for future babies with DDH.

Who may be eligible?

This study is looking for babies who are between birth and 16 weeks old. They need to have been diagnosed with a specific type of hip dysplasia called Graf type 2b or 2c based on an ultrasound scan.

Babies would not be able to join the study if they have other health conditions that might complicate their treatment, such as problems with their nerves, muscles, or genetics. Also, babies whose hips are considered unstable during a physical check-up would not be suitable for this study.

Both boys and girls can take part.

Quick self-check

Is my baby between birth and 16 weeks old?
Has my baby been diagnosed with Graf type 2b or 2c hip dysplasia on an ultrasound scan?
Does my baby NOT have other major health conditions that could affect treatment?
Are my baby's hips stable when a doctor checks them?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide your baby can join this study, they will be randomly assigned to one of two groups, like flipping a coin. One group will receive the usual Pavlik harness treatment. The other group will have their hips carefully monitored.

If your baby is in the harness group, they will wear the Pavlik harness 24 hours a day for up to 12 weeks. They will have ultrasound scans at 3, 8, and 12 weeks after starting the harness. The 8-week scan will help doctors decide how long the harness is needed.

If your baby is in the monitoring group, they won't wear a harness initially. Instead, they will have regular ultrasound scans at 3, 6, 8, and 12 weeks after their diagnosis. If these scans show their hip isn't improving naturally, they will start wearing a Pavlik harness immediately and follow the same plan as the treatment group.

Babies in both groups will also have X-rays of their hips at 9 months and 15 months of age to see how their hips are developing in the long term. The study will follow each baby for 15 months after their diagnosis, with the results shared with families once complete.

Potential risks and benefits

Potential benefits of taking part include contributing to important research that could help future babies with similar hip conditions by clarifying whether a harness is always needed. For babies in the monitoring group, there's a chance they might avoid wearing a harness if their hip improves naturally, which could reduce stress for parents and make daily care easier. Potential risks associated with the Pavlik harness are generally low but can include skin irritation or, very rarely, other complications if not fitted correctly. For babies in the monitoring group, the main potential risk is that if their hip doesn't improve, they would then start the harness treatment, but this would be identified promptly through the frequent scans. You are free to withdraw your baby from the study at any time, for any reason, without it affecting their medical care.

Locations (1)

Maidstone and Tunbridge Wells NHS trust
Royal Tunbridge Wells, United Kingdom· Recruiting

Common questions

What is DDH?

DDH stands for Developmental Dysplasia of the Hip. It means the hip joint hasn't formed correctly, and the top of the thigh bone doesn't fit snugly into the hip socket.

What is a Pavlik harness?

A Pavlik harness is a soft, cloth harness that doctors use to gently hold a baby's legs in a position that encourages the hip joint to develop properly.

Why is this study being done?

The study aims to find out if milder types of DDH (Graf type 2b and 2c) always need a Pavlik harness, or if some babies' hips might get better on their own without it.

Will my baby still get treatment if needed?

Yes. If your baby is in the monitoring group and their hip doesn't improve naturally, they will be given a Pavlik harness immediately.

How long will my baby be in the study?

Each baby will be followed for about 15 months after their initial diagnosis.

How to find out more

Nicole Hilburn, PhD

nicole.hilburn@canterbury.ac.uk +447982027154 Official trial record

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