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Could babies with mild hip dysplasia skip the harness? new trial aims to find out

NCT ID NCT07111858

Disease control Sponsor: Maidstone & Tunbridge Wells NHS Trust Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares the standard Pavlik harness treatment to simply monitoring with ultrasound scans for babies with mild hip dysplasia (Graf type 2b and 2c). About 70 babies will be randomly assigned to either wear the harness or be watched closely. The goal is to see if these mild cases heal on their own, which could spare families the stress and hassle of the harness. The trial will track hip development with scans and X-rays over 15 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pavlik harness (a soft brace that holds a baby's hips in place) versus watchful waiting with ultrasound scans
What this could lead to
If monitoring works as well as the harness, many babies could avoid wearing a brace for weeks, making care easier for parents.
What could go wrong
This is a small feasibility trial, so results may not be definitive. Some babies in the monitoring group may still need a harness if their hips don't mature on their own.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 16 weeks

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: •Infants from birth to 16 weeks with Graf type 2b or 2c hip dysplasia on ultrasound Exclusion Criteria: * associated neuromuscular, genetic or neurological condition which may complicate the course of treatment * babies who have unstable hips on clinical examination

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Conditions

The condition(s) this trial relates to.

developmental dysplasia of the hip

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Developmental hip dysplasia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Maidstone and Tunbridge Wells NHS trust

    RECRUITING

    Royal Tunbridge Wells, United Kingdom