RecruitingNot ApplicableNCT05869851

Developmental Dysplasia of the Hip: Observation vs. Bracing

Comparison of Brace to Observation in Stable, Radiological Developmental Dysplasia of the Hip: A Multi-centre, International Randomized Controlled Non-inferiority Trial


Sponsor

University of British Columbia

Enrollment

514 participants

Start Date

Apr 25, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Max Age: 12 Weeks

Plain Language Summary

Simplified for easier understanding

This study addresses a common pediatric orthopedic question: when a newborn's hip ultrasound shows mild radiological dysplasia (an underdeveloped hip socket) but the hip is clinically stable, is it better to observe the baby and allow natural maturation, or to immediately apply a Pavlik harness (a soft brace)? Developmental dysplasia of the hip (DDH) affects a significant number of infants, but mild forms often resolve on their own — yet without treatment, a small number will worsen and require more invasive correction. The trial aims to define which approach leads to better outcomes with fewer over-treated babies. Eligible infants are under 12 weeks old with ultrasound-confirmed hip dysplasia (alpha angle 43–60 degrees, femoral head coverage above 35%) and clinically stable hips. Infants older than 12 weeks, those with unstable hips (positive Ortolani or Barlow test), known neuromuscular or chromosomal conditions, or those already treated with a harness are excluded. Infants are randomized to watchful waiting or Pavlik harness and monitored with serial hip ultrasounds. This study is important because overtreatment of mild DDH is common — bracing has its own risks including avascular necrosis of the femoral head — and evidence-based guidance on which babies truly need early intervention would improve care for thousands of newborns annually.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERPavlik Harness

The Pavlik harness is an abduction brace used for treatment of hip dysplasia in infants. It keeps the hips in proper alignment to allow for appropriate growth and development of the joint.


Locations(1)

BC Children's Hospital

Vancouver, British Columbia, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05869851


Related Trials