Developmental Dysplasia of the Hip: Observation vs. Bracing

NCT05869851 · tracked via the Priya Life Science Canada tracker

Sponsor

University of British Columbia

Phase

Not applicable

Started

2024-04-25

Last updated

2025-11-24

Condition(s) studied

Developmental Dysplasia of the HipHip DysplasiaHip Dysplasia, CongenitalHip Dysplasia, Developmental

Investigational drug(s) / intervention(s)

Pavlik Harness

Pavlik 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.

Study 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

Sex

ALL

Min age

—

Max age

12 Weeks

Healthy volunteers

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

Primary outcome measure(s)

Acetabular Index — 2 years
A measure of the steepness of the acetabular roof assessed on radiograph.

Trial sites (1)

Facility	City	Region	Status
BC Children's Hospital	Vancouver	British Columbia	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05869851 on ClinicalTrials.gov ↗ ← All trials in Canada