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

Launched by CHILDREN'S HOSPITAL OF PHILADELPHIA · Apr 5, 2017

Keywords

ClinConnect Summary

This clinical trial is studying a new way to check blood flow to the hip in infants who need surgery for developmental dysplasia of the hip (DDH). The researchers want to see if a special type of ultrasound, called contrast-enhanced ultrasound, can give doctors real-time images of blood flow during the surgery. This could help ensure that the blood supply to the hip is healthy, which is important for recovery.

To participate in this study, children need to be between 4 to 24 months old and have been diagnosed with DDH. They should have already tried other treatments that didn't work and are now scheduled for surgery. If your child is selected, you can expect them to receive the usual care for their surgery, along with the contrast-enhanced ultrasound to monitor blood flow. It's important to know that some children may not be eligible due to certain health conditions or previous surgeries. If you're interested, you’ll need to provide permission for your child to take part in the study.

Gender

ALL

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 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.