Recruiting
Early Phase 1

Observational Study

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT03107520

Conditions

Developmental Dysplasia of the Hip

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

Interventions

Intraoperative contrast-enhanced ultrasound (CEUS)

Lumason

Study Details

Brief 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.

Conditions

Developmental Dysplasia of the Hip

Study ID

NCT03107520

Start date

May 22, 2017

Status verified date

Apr, 2026

Completion date

Apr, 2030

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

125 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: DDH Surgical Reduction Patients

Infants treated for DDH who failed conservative measures and are undergoing intraoperative open or closed hip reduction. Intraoperative contrast-enhanced ultrasound using Lumason contrast agent will be administered to improve visualization of the epiphyseal vascularity after hip reduction and during placement of the spica cast.

Interventions

Intraoperative contrast-enhanced ultrasound (CEUS)

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

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

Primary outcome measure

  • Visualization of epiphyseal vascularity in the femoral head [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Wudbhav N Sankar, MD

215-590-1527sankarw@chop.edu

Susan Back, MD

215-590-7000backs@chop.edu

Locations

The Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19014

Contacts

Wudbhav N. Sankar, MD

215-590-1527sankarw@chop.edu

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Keywords

  • contrast-enhanced ultrasound
  • Lumason
  • developmental dysplasia of the hip (DDH)
  • avascular necrosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2026-04-15.