An Early Phase 1 interventional study of Intraoperative contrast-enhanced ultrasound (CEUS) and Lumason in Developmental Dysplasia of the Hip, sponsored by Children's Hospital of Philadelphia. Recruiting at 1 site in United States. Open to participants aged 4 Months to 24 Months. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by Children's Hospital of Philadelphia · Early Phase 1, Interventional, and Diagnostic
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.
For children presenting with late-diagnosed developmental dysplasia of the hip, a closed or open hip reduction followed by hip spica casting may be indicated if conservative treatment fails. Although closed or open reduction and casting is largely successful for relocating a hip, iatrogenic avascular necrosis remains a major source of morbidity as a result of the surgical procedure.
Although recent evidence has demonstrated that postoperative gadolinium-enhanced magnetic resonance (MR) studies may be useful in assessing perfusion of the hip after surgery, these studies are not performed until after the cast is placed and they do not elucidate the specific intraoperative steps that increase risk for osteonecrosis. Contrast-enhanced ultrasound (CEUS) may be a reliable and effective alternative.
60 studies on the registry are indexed under Developmental Dysplasia of the Hip; 18 are open to participants now.
This study's planned enrollment of 125 is above the median of 59 across 38 interventional studies indexed under Developmental Dysplasia of the Hip.
Browse Developmental Dysplasia of the Hip studies →Children's Hospital of Philadelphia is the lead sponsor of 489 studies on the registry; 90 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Infants treated for DDH who failed conservative measures and are undergoing intraoperative open or closed hip reduction. Intraoperative contrast-enhanced ultrasound using Lumason contrast agent will be administered to improve visualization of the epiphyseal vascularity after hip reduction and during placement of the spica cast.
Diagnostic Test: Intraoperative contrast-enhanced ultrasound (CEUS) · Drug: Lumason
An intraoperative CEUS of the dysplastic femoral head will be performed after surgical reduction of the femoral head and during placement of the spica cast.
Administration 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.
Time frame: 1 day
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.
Time frame: Approximately 3 years
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
Time frame: Approximately 3 years
Plan to share: No
Started May 2017 (actual). Primary completion is estimated for Apr 2027, 119 months after the start.
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