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CEUS for Hip Dysplasia

Q: Could you outline other research efforts which have incorporated Intraoperative contrast-enhanced ultrasound (CEUS) in their methodology?

Currently, 14 medical studies exploring Intraoperative contrast-enhanced ultrasound (CEUS) are in progress with two of those trials being Phase 3. Philadelphia, <a href="https://www.withpower.com/clinical-trials/pennsylvania">Pennsylvania</a> is the primary research hub for this technology; nevertheless 18 other locations also have active experiments regarding Intraoperative contrast-enhanced ultrasound (CEUS).

Q: Who qualifies to partake in this research project?

Participants of this trial should have been diagnosed with developmental dysplasia of the hip and must lie between a 4 month to 24 month age range. Altogether, 125 patients are necessary for enrollment into this study.

Q: Is this an innovative or pioneering trial?

As it stands, 14 clinical trials utilizing the Intraoperative contrast-enhanced ultrasound (CEUS) are underway in 10 cities across 3 countries. This technology was initially tested with a 125 patient trial sponsored by Bracco Diagnostics, Inc. back in 2017. Since then, 22 additional experiments have been concluded successfully.

Q: Is this research project currently enrolling new participants?

Affirmative. Clinicaltrials.gov's data affirms that this research endeavor is presently seeking participants; the trial first being posted on May 22nd, 2017 and edited most recently on June 13th 2022. A total of 125 volunteers are needed between one medical facility.

Q: Does the eligibility criterion for this clinical trial include people aged 55 and above?

This medical research is seeking participants between the age of 4 and 24 months.

Q: How many participants are accepted into this medical experiment?

Affirmative. According to the information located on clinicaltrials.gov, this research is actively seeking participants since its inception in May 2017 and last updated in June 2022. 125 individuals are required for recruitment from a single medical facility.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 3 years

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor

708 Previous Clinical Trials

8,582,695 Total Patients Enrolled

Bracco Diagnostics, IncIndustry Sponsor

60 Previous Clinical Trials

11,238 Total Patients Enrolled

Wudbhav N Sankar, MDPrincipal InvestigatorChildren's Hospital of Philadelphia

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you outline other research efforts which have incorporated Intraoperative contrast-enhanced ultrasound (CEUS) in their methodology?

"Currently, 14 medical studies exploring Intraoperative contrast-enhanced ultrasound (CEUS) are in progress with two of those trials being Phase 3. Philadelphia, Pennsylvania is the primary research hub for this technology; nevertheless 18 other locations also have active experiments regarding Intraoperative contrast-enhanced ultrasound (CEUS)."

Answered by AI

Who qualifies to partake in this research project?

"Participants of this trial should have been diagnosed with developmental dysplasia of the hip and must lie between a 4 month to 24 month age range. Altogether, 125 patients are necessary for enrollment into this study."

Answered by AI

Is this an innovative or pioneering trial?

"As it stands, 14 clinical trials utilizing the Intraoperative contrast-enhanced ultrasound (CEUS) are underway in 10 cities across 3 countries. This technology was initially tested with a 125 patient trial sponsored by Bracco Diagnostics, Inc. back in 2017. Since then, 22 additional experiments have been concluded successfully."

Answered by AI

Is this research project currently enrolling new participants?

"Affirmative. Clinicaltrials.gov's data affirms that this research endeavor is presently seeking participants; the trial first being posted on May 22nd, 2017 and edited most recently on June 13th 2022. A total of 125 volunteers are needed between one medical facility."

Answered by AI

Does the eligibility criterion for this clinical trial include people aged 55 and above?

"This medical research is seeking participants between the age of 4 and 24 months."

Answered by AI

How many participants are accepted into this medical experiment?

"Affirmative. According to the information located on clinicaltrials.gov, this research is actively seeking participants since its inception in May 2017 and last updated in June 2022. 125 individuals are required for recruitment from a single medical facility."

Answered by AI

Recent research and studies

Pediatric RadiologyJournal

Safety of Contrast-enhanced Ultrasound in Children for Non-cardiac Applications: A Review by the Society for Pediatric Radiology (SPR) and the International Contrast Ultrasound Society (ICUS)

Darge, Kassa, Frederica Papadopoulou, Aikaterini Ntoulia, Dorothy I. Bulas, Brian D. Coley, Lynn A. Fordham, Harriet J. Paltiel, et al.. 2013. “Safety of Contrast-enhanced Ultrasound in Children for Non-cardiac Applications: A Review by the Society for Pediatric Radiology (SPR) and the International Contrast Ultrasound Society (ICUS)”. Pediatric Radiology. Springer Science and Business Media LLC. doi:10.1007/s00247-013-2746-6.

RadioGraphicsJournal

MR Imaging in Postreduction Assessment of Developmental Dysplasia of the Hip: Goals and Obstacles

Rosenbaum, Daniel G., Sabah Servaes, Eric A. Bogner, Diego Jaramillo, and Douglas N. Mintz. 2016. “MR Imaging in Postreduction Assessment of Developmental Dysplasia of the Hip: Goals and Obstacles”. Radiographics. Radiological Society of North America (RSNA). doi:10.1148/rg.2016150159.

Journal of Pediatric OrthopaedicsJournal

Post-closed Reduction Perfusion Magnetic Resonance Imaging as a Predictor of Avascular Necrosis in Developmental Hip Dysplasia

Tiderius, Carl, Diego Jaramillo, Susan Connolly, Michael Griffey, Diana P. Rodriguez, James R. Kasser, Michael B. Millis, David Zurakowski, and Young-Jo Kim. 2009. “Post-closed Reduction Perfusion Magnetic Resonance Imaging as a Predictor of Avascular Necrosis in Developmental Hip Dysplasia”. Journal of Pediatric Orthopaedics. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/bpo.0b013e3181926c40.

Clinical Orthopaedics & Related ResearchJournal