Developmental Dysplasia of the Hip: Observation vs. Bracing
Developmental dysplasia of the hip (DDH) is the most common childhood hip condition. When caught early, bracing is the most frequently used treatment; however, the brace can disrupt important mother-baby bonding time in the newborn period and present challenges to daily living. In babies with mild DDH, some studies hav
| Condition(s) | Developmental Dysplasia of the Hip, Hip Dysplasia, Hip Dysplasia, Congenital, Hip Dysplasia, Developmental |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Developmental dysplasia of the hip (DDH) is the most common childhood hip condition. When caught early, bracing is the most frequently used treatment; however, the brace can disrupt important mother-baby bonding time in the newborn period and present challenges to daily living. In babies with mild DDH, some studies have suggested that their hips may improve naturally as they grow and develop. This study will look at whether careful monitoring can be just as good as bracing for babies diagnosed with mild DDH less than 3 months of age, potentially avoiding unnecessary treatment. This will be the first study to look at this question with babies being treated at different hospitals in seven different countries, so the results will make an impact on children and families worldwide. |
| Who can participate | 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 |
| Ages | 12 Weeks |
| Sex | All |
| Lead sponsor | University of British Columbia |
| Locations | Vancouver, British Columbia, Canada |
| Start date | 2024-04-25 |
| NCT ID | NCT05869851 |
| Official listing | https://clinicaltrials.gov/study/NCT05869851 |