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Recruiting EARLY_Phase 1 NCT03107520

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

Trial Parameters

Condition Developmental Dysplasia of the Hip
Sponsor Children's Hospital of Philadelphia
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 125
Sex ALL
Min Age 4 Months
Max Age 24 Months
Start Date 2017-05-22
Completion 2027-04
Interventions
Intraoperative contrast-enhanced ultrasound (CEUS)Lumason

Brief 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 Criteria

Inclusion Criteria: * 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) Exclusion Criteria: * \> 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. * History of allergic reaction to Lumason, sulfur hexafluo

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