Comparing Pavlik Harness Treatment and Monitoring for Babies with Graf Type 2b and 2c Hip Dysplasia

What this Trial Is About

Developmental Dysplasia of the Hip DDH is a common condition in infants that can lead to disability if not treated properly. This research aims to find out whether babies with stable but immature Graf type 2b and 2c hips need treatment with a Pavlik harness or if their hips can mature naturally without it. The study is a feasibility trial conducted to compare the outcomes of babies treated with the harness versus those who are closely monitored without initial treatment. Babies in the study will be randomly assigned to one of two groups. One group will receive the usual care involving a Pavlik harness worn 24 hours a day for up to 12 weeks, with ultrasound scans at 3, 8, and 12 weeks after treatment begins. The other group will be under watchful waiting, having ultrasound scans every 3 weeks at 3, 6, 9, and 12 weeks to monitor hip maturation. If hips in the monitoring group do not mature, babies will be switched to harness treatment. Both groups will have X-rays taken at 9 and 15 months to assess long-term hip development. Participants will undergo baseline assessments including ultrasound and physical exams, and parents will complete stress questionnaires at various points. The harness group will have regular checks to ensure proper fit and monitor skin and nerve health. Parents in both groups will have access to support and emergency contact. The study will last 15 months per participant, with data collected on hip development, parent stress, and treatment outcomes to help determine if harness treatment is necessary for stable, immature hips.

Pavlik Harness Treatment vs Monitoring for Treatment of Developmental Dysplasia of the Hip (DDH) in Babies Diagnosed With Graf Type 2 Hips