Does Perfusion MRI After Closed Reduction of Developmental Dysplasia of the Hip Reduce the Incidence of Avascular Necrosis?
Alex L Gornitzky, Andrew G Georgiadis, Mark A Seeley...
https://pubmed.ncbi.nlm.nih.gov/26092677/Actively Recruiting
Led by Children's Hospital of Philadelphia · Updated on 2026-04-15
125
Participants Needed
1
Research Sites
156 weeks
Total Duration
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 hips 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.
CONDITIONS
Intraoperative Contrast-Enhanced Ultrasound Evaluation of Blood Flow at the Time of Surgical Hip Reduction for DDH
W
Wudbhav N Sankar, MD
S
Susan Back, MD
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Children's Hospital of Philadelphia
Lead Sponsor
Bracco Diagnostics, Inc
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Intraoperative CEUS with Lumason | Post-Reduction Perfusion MRI |
|---|---|---|
| What is it? | Intraoperative contrast-enhanced ultrasound (CEUS) using the Lumason agent to visualize blood flow in the femoral head immediately after surgical reduction and during spica casting in children with DDH. | Perfusion MRI performed after closed or open reduction, measuring femoral head blood supply to evaluate and predict risk of avascular necrosis in pediatric DDH patients. |
| Role in trial/study | Investigational diagnostic imaging method evaluated for real-time vascular assessment during surgery. | Not a trial comparator arm; represents the established imaging technique for postoperative vascular assessment and avascular necrosis prediction. |
| Primary clinical use | Immediate intraoperative visualization of femoral head perfusion to help assess blood supply and predict risk of avascular necrosis at the time of hip reduction. | Postoperative imaging of femoral head vascularity to evaluate blood flow and predict avascular necrosis after hip reduction for DDH. |
| How is it given or performed? | Lumason contrast agent administered intravenously during surgery, followed by intraoperative ultrasound imaging of the femoral head after reduction and during spica cast application. | Perfusion MRI conducted after surgery and casting, typically during routine follow-up, to assess femoral head blood supply and detect AVN risk. |
| Evidence status | Active trial; published pediatric safety reviews affirm CEUS can be used for vascular imaging in non-cardiac applications, but outcome evidence for intraoperative use in DDH is not yet established. | Multiple studies confirm perfusion MRI reliably measures femoral head blood flow and predicts avascular necrosis risk after hip reduction in children with DDH. |
| Important limitations | Limited data on intraoperative CEUS for predicting AVN after DDH reduction. Real-time imaging is promising but may be subject to operator variability and requires further validation. | Perfusion MRI requires sedation in young children, is not performed intraoperatively, and may not offer immediate vascular feedback. MRI access may be limited and imaging is usually performed postoperatively. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery
Participants undergo surgical hip reduction with intraoperative contrast-enhanced ultrasound using Lumason contrast agent to evaluate blood flow during the procedure and placement of the spica cast.
1 intraoperative visit (in-person)
Duration - Approximately 3 years
Participants are monitored after surgery to assess hip perfusion and the likelihood of developing avascular necrosis over time using imaging and clinical evaluations.
Follow-up visits as scheduled over 3 years
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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Lead Sponsor
Bracco Diagnostics, Inc
Collaborating Sponsor