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Evaluating Blood Flow During Hip Surgery for DDH with Contrast Ultrasound

This study is looking at a new way to check blood flow in the hip during surgery for Developmental Dysplasia of the Hip (DDH). DDH is a condition where the hip joint doesn't form properly. Researchers will use an Intraoperative contrast-enhanced ultrasound (CEUS) with Lumason, a special contrast agent, to see the blood flow in the hip bone right after surgery and while a cast is being put on. This helps doctors understand if the surgery is affecting blood flow, which is important for healing. The study aims to see if this ultrasound method can clearly show the blood vessels in the hip bone. Children between 4 and 24 months old who are having surgery for DDH and have either not responded to other treatments or were diagnosed later can participate. The study plans to enroll 125 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific intervention (CEUS with Lumason). It plans to include 125 participants.
What's involved
You would undergo an Intraoperative contrast-enhanced ultrasound (CEUS) of the hip after surgical reduction and during cast placement. Lumason contrast agent would be administered.
Compensation
Not stated in the trial record.
Follow-up
Blood flow visualization will be measured at 1 day after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03107520

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

Recruiting
EARLY_PHASE1Ages 4–24InterventionalDiagnostic
Children's Hospital of Philadelphia
~125 participants
Updated 2026-04-15 on ClinicalTrials.gov
What's tested:Intraoperative contrast-enhanced ultrasound (CEUS)Lumason

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Visualization of epiphyseal vascularity in the femoral head
Measured over 1 day

Conditions

Developmental Dysplasia of the Hip

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Developmental Dysplasia of Hip

NCT03107520

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Wudbhav N Sankar, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital of Philadelphia
  • Susan Back, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital of Philadelphia

Who to contact

Wudbhav N Sankar, MD
[email protected]
215-590-1527
Email the study team

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Eligibility criteria

Inclusion

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

\> 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.

What this trial measures

  • Visualization of epiphyseal vascularity in the femoral head1 day

    The visualization of epiphyseal vascularity on the sonogram from intraoperative CEUS will be assessed by a trained sonographer and musculoskeletal radiologist administering the CEUS and reviewing the images.