Intraoperative Contrast-Enhanced Ultrasound Evaluation of Blood Flow at the Time of Surgical Hip Reduction for DDH
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
Children's Hospital of Philadelphia
125 participants
May 22, 2017
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria5
- \> 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 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.
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Interventions
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.
Locations(1)
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NCT03107520