This study evaluates the feasibility and utility 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.
Males or females between 4 months and up to and including 24 months of age at the time of surgery.
Diagnosed with DDH.
Failed conservative treatment, or present with late-diagnosed DDH (where conservative treatment would not be appropriate to initiate at their age), and are undergoing closed or open reduction and spica casting.
Informed consent (parental permission)
> 24 months of age at the time of surgery.
Subjects with DDH who are successfully treated with conservative measures and do not require surgical reduction.
Previous open hip reduction of the affected side
Children with known complex congenital heart disease or unstable cardiopulmonary conditions (as noted in the package labeling for Lumason) including acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure or serious ventricular arrhythmias will be excluded.
Single group
Intraoperative contrast-enhanced ultrasound (CEUS)
Diagnostic testAn intraoperative CEUS of the dysplastic femoral head will be performed after surgical reduction of the femoral head and during placement of the spica cast.
Lumason
DrugAdministration of Lumason contrast agent to improve visualization of epiphyseal vascularity in the femoral head.
Visualization of epiphyseal vascularity in the femoral head
The visualization of epiphyseal vascularity on the sonogram from intraoperative CEUS will be assessed by a trained sonographer and musculoskeletal radiologist administering the CEUS and reviewing the images.
Comparison of CEUS and Post-Operative Imaging
The images obtained via intraoperative CEUS will be compared to standard-of-care postoperative perfusion MR imaging and 1-year follow-up radiographs.
Estimate and predict the likelihood of developing avascular necrosis
To estimate the relationship and predict the likelihood of developing avascular necrosis (outcome variable) and CEUS performance (explanatory variable) as measured by CEUS score
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Children's Hospital of Philadelphia
Lead sponsor
Bracco Diagnostics, Inc
Collaborator
Pediatric Orthopaedic Society of North America
Collaborator
