← Back to Search

CEUS for Hip Dysplasia

Phase < 1
Recruiting
Led By Wudbhav N Sankar, MD
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males or females between 4 months and up to and including 24 months of age at the time of surgery
Failed conservative treatment and are undergoing closed or open reduction and spica casting
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 3 years
Awards & highlights

Study Summary

This trial looks at using ultrasound to see blood flow to the hip in infants with hip dysplasia to see if it's a useful tool.

Who is the study for?
This trial is for boys and girls aged 4-24 months diagnosed with developmental dysplasia of the hip (DDH) who haven't improved with non-surgical treatments and are now facing surgery. It's not for kids over 2 years old, those who've had previous hip surgeries, or have allergies to Lumason components.Check my eligibility
What is being tested?
The study tests if a special ultrasound called contrast-enhanced ultrasound (CEUS), using a product named Lumason, can effectively show blood flow in the femoral head during hip surgery for infants with DDH.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to ingredients in Lumason like sulfur hexafluoride or polyethylene glycol. However, specific side effects related to CEUS in this context aren't detailed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a child aged between 4 months and 24 months.
Select...
I have tried non-surgical treatments without success and am now scheduled for a specific type of bone realignment and casting.
Select...
I have been diagnosed with developmental dysplasia of the hip.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Visualization of epiphyseal vascularity in the femoral head
Secondary outcome measures
Comparison of CEUS and Post-Operative Imaging
Estimate and predict the likelihood of developing avascular necrosis

Trial Design

1Treatment groups
Experimental Treatment
Group I: DDH Surgical Reduction PatientsExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lumason
2015
Completed Phase 4
~390

Find a Location

Who is running the clinical trial?

Pediatric Orthopaedic Society of North AmericaOTHER
7 Previous Clinical Trials
1,335 Total Patients Enrolled
Children's Hospital of PhiladelphiaLead Sponsor
710 Previous Clinical Trials
8,588,839 Total Patients Enrolled
Bracco Diagnostics, IncIndustry Sponsor
61 Previous Clinical Trials
11,344 Total Patients Enrolled

Media Library

Intraoperative contrast-enhanced ultrasound (CEUS) Clinical Trial Eligibility Overview. Trial Name: NCT03107520 — Phase < 1
Developmental Dysplasia of the Hip Research Study Groups: DDH Surgical Reduction Patients
Developmental Dysplasia of the Hip Clinical Trial 2023: Intraoperative contrast-enhanced ultrasound (CEUS) Highlights & Side Effects. Trial Name: NCT03107520 — Phase < 1
Intraoperative contrast-enhanced ultrasound (CEUS) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03107520 — Phase < 1
~13 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top