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Taking people in United StatesEarly phase 1

Intraoperative Contrast-Enhanced Ultrasound Evaluation of Blood Flow at the Time of Surgical Hip Reduction for DDH

Key facts

Who runs it
Children's Hospital of Philadelphia
Where
Philadelphia, United StatesSee the site
Trial code
Status
Recruiting
Phase
Early phase 1
People taking part
125 people, planned
Started
22 May 2017
Expected to end
Apr 2030
Type of study
Interventional
Treatments tested
  • Intraoperative contrast-enhanced ultrasound (CEUS)
  • Lumason
Record updated
15 April 2026

Who can take part

Age
4 months to 24 months
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • 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
  • History of allergic reaction to Lumason, sulfur hexafluoride, sulfur hexafluoride lipid microsphere components, or other ingredients in Lumason (polyethylene glycol, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Ns), palmitic acid).Parental/guardian permission (informed consent) and if appropriate, child assent
  • > 24 months of age at the time of surgery

Where in United States

  • The Children's Hospital Of PhiladelphiaPhiladelphia, United StatesContact: Wudbhav N. Sankar, MDTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • DDH Surgical Reduction PatientsTreatment being tested

    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.

    Treatment: Intraoperative contrast-enhanced ultrasound (CEUS) and Lumason

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Record updated
15 April 2026