Comparing observation and bracing for mild hip dysplasia in infants
Official title: Comparison of Brace to Observation in Stable, Radiological Developmental Dysplasia of the Hip: A Multi-centre, International Randomized Controlled Non-inferiority Trial
Run by University of British Columbia · NCT05869851 · Data updated 2026-11-12
This study tests if watching and monitoring infants with mild hip dysplasia is just as good as using braces to help them, to see if we can avoid unnecessary treatments.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 12 Weeks |
| Sex | All |
| Enrollment | 514 (estimated) |
| Sponsor | University of British Columbia Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Status | Recruiting |
| Started | April 25, 2024 |
| Main results expected | September 2027 |
| Study ends | September 2028 |
| Registry record updated | November 24, 2025 |
| Trial ID | NCT05869851 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are infants under three months of age with radiological dysplasia of a clinically stable hip.
✕Probably not a fit
Patients older than three months or those with clinical hip instability or other congenital abnormalities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates whether careful monitoring can be as effective as bracing for infants diagnosed with mild developmental dysplasia of the hip (DDH) under three months of age. By comparing outcomes between these two approaches, the research aims to determine if unnecessary treatment can be avoided, thereby reducing potential complications and psychosocial impacts on families. The study will involve infants from various hospitals across seven countries, making it a significant international effort to improve care for this common childhood condition.
Why it matters
Potential benefit: If successful, this study could lead to more effective and less invasive treatment options for infants with mild DDH, enhancing family bonding and reducing healthcare costs.
How similar studies have gone: While this approach of careful observation has been suggested in previous studies, this is the first large-scale investigation to directly compare it with bracing in infants with mild DDH.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients presenting with radiological dysplasia of a clinically stable hip under three months (12 weeks) of age * Radiological dysplasia will be defined as a centred hip with an alpha angle between 43 and 60 degrees and a percent coverage of the femoral head (FHC) greater than 35%, as measured on ultrasound exam Exclusion Criteria: * Patients presenting with radiological dysplasia older than three months (12 weeks) of age * Patients presenting with clinical hip instability (Ortolani or Barlow positive) * Patients with known or suspected neuromuscular, collagen, chromosomal or lower-extremity congenital abnormalities or syndromic-associated hip abnormalities * Patients who received prior treatment (i.e. Pavlik harness) for DDH
Where it's running
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BC Children's Hospital
Vancouver, British Columbia, Canada Recruiting
Study contacts
- Principal investigator: Kishore Mulpuri, FRCSC — University of British Columbia
- Study coordinator: Emily Schaeffer, PhD
- Email: emily.schaeffer@cw.bc.ca
- Phone: 604-875-2359
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.