Developmental Dysplasia of the Hip: Observation Vs. Bracing
Study Details
Comparison of Brace to Observation in Stable, Radiological Developmental Dysplasia of the Hip: a Multi-centre, International Randomized Controlled Non-inferiority Trial
Conditions: Developmental Dysplasia of the Hip, Hip Dysplasia, Congenital Hip Dysplasia, Developmental Hip Dysplasia
Study ID:
ORT23125 (Brace v. Observational)
Study Description
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.
Eligibility Requirements
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 centered 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
Principal Investigator
Kevin Horowitz
More Information
To learn more visit: https://clinicaltrials.gov/study/NCT05869851.
This page was last updated on: June 13, 2025 02:29 PM