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

Conditions

• Developmental Dysplasia of the Hip

Eligibility Criteria

Sex

ALL

Age

4 Months - 24 Months

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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 Dates

Start date

May 22, 2017

Status verified

Apr 2026

Primary completion

Apr 30, 2027

Completion

Apr 30, 2030

Study Design

Enrollment

125 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

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.

Primary Outcome Measure

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

Central Contacts

• Wudbhav N Sankar, MD
  215-590-1527
  [email protected]
• Susan Back, MD
  215-590-7000
  [email protected]

Locations (1)

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