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NCT Number: NCT03107520

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

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.

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Key information

Age range

4 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19014, United States

Location status: Recruiting

Location contact

Wudbhav N. Sankar, MD

CONTACT

[email protected]

215-590-1527

About this study

For children presenting with late-diagnosed developmental dysplasia of the hip, a closed or open hip reduction followed by hip spica casting may be indicated if conservative treatment fails. Although closed or open reduction and casting is largely successful for relocating a hip, iatrogenic avascular necrosis remains a major source of morbidity as a result of the surgical procedure.

Although recent evidence has demonstrated that postoperative gadolinium-enhanced magnetic resonance (MR) studies may be useful in assessing perfusion of the hip after surgery, these studies are not performed until after the cast is placed and they do not elucidate the specific intraoperative steps that increase risk for osteonecrosis. Contrast-enhanced ultrasound (CEUS) may be a reliable and effective alternative.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intraoperative contrast-enhanced ultrasound (CEUS)

Diagnostic Test

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.

Lumason

Drug

Administration of Lumason contrast agent to improve visualization of epiphyseal vascularity in the femoral head.

Primary outcomes

  1. Visualization of epiphyseal vascularity in the femoral head

    Time frame: 1 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.

Secondary outcomes

  1. Comparison of CEUS and Post-Operative Imaging

    Time frame: Approximately 3 years

    The images obtained via intraoperative CEUS will be compared to standard-of-care postoperative perfusion MR imaging and 1-year follow-up radiographs.

  2. Estimate and predict the likelihood of developing avascular necrosis

    Time frame: Approximately 3 years

    To estimate the relationship and predict the likelihood of developing avascular necrosis (outcome variable) and CEUS performance (explanatory variable) as measured by CEUS score

Study contacts

Contact information is provided by the study sponsor or research team.

Susan Back, MD

CONTACT

[email protected]

215-590-7000

Wudbhav N Sankar, MD

CONTACT

[email protected]

215-590-1527

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Bracco Diagnostics, Inc
  • Pediatric Orthopaedic Society of North America

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2027
Study completion
2030
First posted
Apr 11, 2017
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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