Pavlik harness versus monitoring for babies with Graf type 2 hip dysplasia
Pavlik Harness Treatment Versus Monitoring for Treatment of Graf Type 2b and 2c Hip Developmental Dysplasia of the Hip (DDH)
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 0 Weeks to 16 Weeks |
| Sex | All |
| Sponsor | Maidstone & Tunbridge Wells NHS Trust Academic / other |
| Locations | 1 site (Royal Tunbridge Wells) |
| Trial ID | NCT07111858 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Royal Tunbridge Wells
- Maidstone and Tunbridge Wells NHS trust — Royal Tunbridge Wells, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Nicole Hilburn, PhD
- Email: nicole.hilburn@canterbury.ac.uk
- Phone: +447982027154
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.