Intraoperative Contrast-Enhanced Ultrasound Evaluation of Blood Flow at the Time of Surgical Hip Reduction for DDH
Recruiting now · Early Phase 1
Conditions studied: Developmental Dysplasia of the Hip
In brief
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.
Key facts
- Study ID
- NCT03107520
- Run by
- Children's Hospital of Philadelphia
- People needed
- 125
- Starts
- 2017-05-22
- Expected to finish
- 2030-04-01
- Last updated by the study team
- 2026-04-15
Who can join
Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- > 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.
Where it is running
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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