Clinical trial Recruiting at 1 site Interventional Ages 0 Weeks to 16 Weeks

Pavlik harness versus monitoring for babies with Graf type 2 hip dysplasia

Official title: Pavlik Harness Treatment Versus Monitoring for Treatment of Graf Type 2b and 2c Hip Developmental Dysplasia of the Hip (DDH)

Run by Maidstone & Tunbridge Wells NHS Trust · NCT07111858 · Data updated 2026-11-12

This project will test whether a Pavlik harness or watchful waiting works better for babies up to 16 weeks old with Graf type 2b or 2c hip dysplasia.

More Developmental Dysplasia of the Hip trials

Quick facts

Study typeInterventional
Ages0 Weeks to 16 Weeks
SexAll
Enrollment70 (estimated)
SponsorMaidstone & Tunbridge Wells NHS Trust
Academic / other
Locations1 site (Royal Tunbridge Wells)
StatusRecruiting
StartedAugust 2, 2023
Main results expectedDecember 2026
Study endsJune 2027
Registry record updatedMarch 23, 2026
Trial IDNCT07111858 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Infants from birth to 16 weeks with Graf type 2b or 2c hip dysplasia on ultrasound who have stable hips on clinical exam and no neuromuscular, genetic, or neurological conditions.

Probably not a fit

Babies with clinically unstable hips, known neuromuscular/genetic/neurological conditions, or those older than 16 weeks are unlikely to benefit from the monitoring approach and may require standard treatment.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This feasibility trial will recruit infants from birth to 16 weeks diagnosed by ultrasound with Graf type 2b or 2c hips and compare 24-hour Pavlik harness treatment for up to 12 weeks with watchful waiting and supportive care. Participants will be followed with repeat ultrasound and clinical examinations to document hip maturation and any need for later intervention. The trial will also capture feasibility outcomes such as recruitment rates, adherence to treatment, and parental acceptability. Findings will inform whether routine harnessing is necessary for these borderline hips and whether a larger definitive trial is warranted.

Why it matters

Potential benefit: If successful, the trial could spare some babies and families unnecessary Pavlik harness treatment, reducing parental stress and avoiding unneeded medical intervention.

How similar studies have gone: Direct randomized evidence for managing borderline Graf type 2 hips is limited and most centers currently treat these hips with a Pavlik harness rather than monitoring.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.