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

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

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03107520

Enrollment

125

Registered

2017-04-11

Start date

2017-05-22

Completion date

2030-04-30

Last updated

2025-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Developmental Dysplasia of the Hip

Keywords

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

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTIntraoperative 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.

DRUGLumason

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Masking description

The surgeon and musculoskeletal radiologist administering the contrast-enhanced ultrasound will not be blinded at the time of the intervention; however, they will be blinded when comparing the results of the CEUS to standard-of-care perfusion MRI and 3-years postop radiographs.

Eligibility

Sex/Gender

ALL

Age

4 Months to 24 Months

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Visualization of epiphyseal vascularity in the femoral head	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

Measure	Time frame	Description
Comparison of CEUS and Post-Operative Imaging	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.
Estimate and predict the likelihood of developing avascular necrosis	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

Countries

United States

Contacts

Primary ContactWudbhav N Sankar, MD

sankarw@chop.edu215-590-1527

Backup ContactSusan Back, MD

backs@chop.edu215-590-7000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026