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

Early Phase 1

Recruiting

• Conditions: Developmental Dysplasia of the Hip
• Interventions: Diagnostic Test: Intraoperative contrast-enhanced ultrasound (CEUS); Drug: Lumason

• Registration Number: NCT03107520
• Lead Sponsor: Children's Hospital of Philadelphia

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.

Study Timeline

• Study First Submitted: 2017-03-23
• Study First Submitted QC: 2017-04-05
• Study First Posted: 2017-04-11
• Study Start: 2017-05-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2027-04
• Study Completion: 2030-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DDH Surgical Reduction Patients	Intraoperative contrast-enhanced ultrasound (CEUS)	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.
DDH Surgical Reduction Patients	Lumason	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 Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.

Trial Locations

Locations (1)

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States