About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Pavlik Harness
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Acetabular Index
A measure of the steepness of the acetabular roof assessed on radiograph.
Secondary outcomes
Alpha Angle
This angle is measured via ultrasound and refers to the angle between the acetabular roof and vertical cortex of the ilium.
Beta Angle
This angle is measured via ultrasound and refers to the angle formed between the vertical cortex of the ilium and the triangular labral fibrocartilage (echogenic triangle).
Percent Femoral Head Coverage
Measured via ultrasound and assesses the percentage of the femoral epiphysis covered by the acetabular roof.
Number of Participants that Experienced Complications
Including development of femoral nerve palsy or avascular necrosis, progression of hip dysplasia, and need for further treatment.
Other outcomes
Centre Edge Angle
To be assessed for participants who elect to take part in the Global Hip Dysplasia Registry and have available data. Measured on x-ray, it is the angle formed between the vertical axis of the pelvis and a line from the centre of the femoral head to the lateral edge of the acetabulum.
Sponsors and contacts
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