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
Who is this study for? Infants undergoing surgical reduction for developmental dysplasia of the hip
What treatments are being studied? Intraoperative contrast-enhanced ultrasound+Lumason
Status: Recruiting
Location: See location...
Intervention Type: Drug, Diagnostic test
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 4 months
Maximum Age: 2
Healthy Volunteers: f
View:
• 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)
Locations
United States
Pennsylvania
The Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Contact Information
Primary
Wudbhav N Sankar, MD
sankarw@chop.edu
215-590-1527
Backup
Susan Back, MD
backs@chop.edu
215-590-7000
Time Frame
Start Date: 2017-05-22
Estimated Completion Date: 2030-04
Participants
Target number of participants: 125
Treatments
Experimental: DDH Surgical Reduction Patients
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.
Authors
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital of Philadelphia
Collaborators: Pediatric Orthopaedic Society of North America, Bracco Diagnostics, Inc