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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age4-24
SponsorChildren's Hospital of Philadelphia

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

> 24 months of age at the time of surgery.

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.

Trial design

Treatments tested in this trial

  • Intraoperative contrast-enhanced ultrasound (CEUS)
  • Lumason

Treatment groups

125 Participants
are divided into 1 treatment group

Sponsors and collaborators

Children's Hospital of Philadelphia

Lead sponsor

Bracco Diagnostics, Inc

Collaborator

Pediatric Orthopaedic Society of North America

Collaborator