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8 vs 12 Weeks: A Pavlik Harness Trial

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
Developmental dysplasia of the hip is the most common bone and joint condition in babies. It is usually treated with a harness that holds the hips in a safe position so they can develop normally. After the hip is confirmed to be in the correct position, babies are commonly kept in the harness for up to 12 weeks or more. While effective, wearing a harness for this length of time can be challenging for families. It can make everyday care such as feeding, bathing and dressing more difficult, and add stress during an important time for bonding. This trial compares two treatment options: 8 versus 12 weeks of harness wear. The 8-week option is being tested because research has shown that most hips appear normal on ultrasound by this point. The main measure of success is whether the hip looks normal on x-ray two years after treatment. Families will also be asked about their experience and treatment-related problems. If the shorter option is as effective as the longer option, many babies could spend less time in brace, reducing burden without compromising outcomes. Because this trial is embedded in routine care, results can be put into practice quickly and guide care for babies across Ontario and beyond.
Trial Details
NCT Number NCT07847619
Lead Sponsor The Hospital for Sick Children
Conditions
(from sponsor)
Developmental Dysplasia of Hip, DDH, Developmental Dysplasia of the Hip, Developmental Dysplasia of the Hip (DDH), Hip Dysplasia, Developmental, Hip Dysplasia, Congenital, Nonsyndromic
Related terms Developmental Dysplasia of the Hip, Hip Dislocation, Hip Dislocation, Congenital
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov