Comparing observation and bracing for mild hip dysplasia in infants
Comparison of Brace to Observation in Stable, Radiological Developmental Dysplasia of the Hip: A Multi-centre, International Randomized Controlled Non-inferiority Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 514 (estimated) |
| Ages | N/A to 12 Weeks |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT05869851 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are infants under three months of age with radiological dysplasia of a clinically stable hip.
Not a fit: Patients older than three months or those with clinical hip instability or other congenital abnormalities may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Vancouver, British Columbia
- 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
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.