Comparison of Brace to Observation in Stable, Radiological Developmental Dysplasia of the Hip: International Randomized Controlled Trial

What this Trial Is About

Developmental dysplasia of the hip (DDH) is a common condition affecting infants, where the hip joint does not develop properly. This research compares two approaches to managing mild DDH in babies under three months old: using a brace called the Pavlik harness versus careful observation. The goal is to see if monitoring without bracing works just as well, potentially avoiding unnecessary treatment and its challenges. The trial is international, involving multiple hospitals across seven countries, aiming to impact care for children worldwide. Babies in this study will be randomly assigned to one of two groups. One group will receive the Pavlik harness, an abduction brace worn for at least six weeks to help position the hips correctly. The other group will be closely observed with regular ultrasound exams but will not wear a brace. This trial builds on an existing global registry of DDH patients and will compare outcomes between these groups over time. During the study, participants will have ultrasounds and clinical assessments at various times, including at six weeks and up to two years. Researchers will measure hip development using angles and coverage of the femoral head, track any complications, and gather feedback from parents about their experience and satisfaction. Health resource use will also be recorded in some centers. The primary outcome is the acetabular index measured at two years, with ongoing monitoring to evaluate the safety and effectiveness of observation versus bracing.

Developmental Dysplasia of the Hip: Observation vs. Bracing