Use of Intraoperative Contrast-enhanced Ultrasound to Evaluate Femoral Head Perfusion in Infants With Developmental Dysplasia of the Hip at the Time of Surgical Reduction

What this Trial Is About

This research aims to evaluate the use of contrast-enhanced ultrasound to provide real-time assessment of blood flow to the femoral head in infants undergoing surgical reduction for developmental dysplasia of the hip (DDH). The study focuses on infants who have failed conservative treatments and require surgical intervention, addressing concerns about avascular necrosis, a serious complication related to blood supply loss after surgery. Traditional postoperative imaging methods do not provide information during the surgery itself, so this study explores if contrast-enhanced ultrasound can fill that gap. Participants receive an intraoperative contrast-enhanced ultrasound (CEUS) using the Lumason contrast agent. This procedure is performed after the surgical reduction of the femoral head and during the placement of the spica cast to better visualize blood flow to the hip's epiphyseal vascularity. The study is an early phase 1 trial involving infants between 4 months and 24 months old undergoing either closed or open hip reduction. During the study, researchers will monitor the visualization of blood flow in the femoral head immediately after surgery. They will compare CEUS findings with post-operative imaging over approximately three years to estimate the likelihood of developing avascular necrosis. Parental permission is required, and the study includes follow-up assessments to evaluate outcomes. The total participation includes the surgery day and long-term monitoring of hip health.

Intraoperative Contrast-Enhanced Ultrasound Evaluation of Blood Flow at the Time of Surgical Hip Reduction for DDH