The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19014, United States
Location status: Recruiting
NCT Number: NCT03107520
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.
Interested in participating?
Request Info4 month–24 month
All sexes
Interventional
Early Phase 1
Philadelphia, Pennsylvania, 19014, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 1 day
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: Approximately 3 years
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
To estimate the relationship and predict the likelihood of developing avascular necrosis (outcome variable) and CEUS performance (explanatory variable) as measured by CEUS score
Contact information is provided by the study sponsor or research team.
Susan Back, MD
CONTACT
Wudbhav N Sankar, MD
CONTACT
Children's Hospital of Philadelphia
Other
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
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