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

NCT03107520 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2026-04-15

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

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.

DRUG

Lumason

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

Sponsors & Collaborators

Principal Investigators

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

  • Susan Back, MD · Children's Hospital of Philadelphia

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-22
Primary Completion
2027-04-30
Completion
2030-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03107520 on ClinicalTrials.gov