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

Hip Dysplasia Developmental Dysplasia of the Hip Hip Dysplasia, Congenital Hip Dysplasia, Developmental

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

Inclusion Criteria2

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 Criteria4

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

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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.