CEUS for Hip Dysplasia

Overseen By Susan Back, MD

Age: < 18

Sex: Any

Trial Phase: Phase < 1

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Complex heart disease, Unstable cardiopulmonary, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

125 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Intraoperative contrast-enhanced ultrasound (CEUS) for hip dysplasia?

Research suggests that contrast-enhanced ultrasound (CEUS) can effectively assess blood flow in real time, making it a promising tool for evaluating femoral head perfusion during surgery for hip dysplasia, potentially preventing complications like avascular necrosis. ^{1 2 3 4 5}

Is contrast-enhanced ultrasound (CEUS) safe for use in humans?

Contrast-enhanced ultrasound (CEUS) is generally considered safe for use in humans, as it is a non-invasive method that does not involve ionizing radiation. It has been used to assess blood flow in various conditions, including developmental dysplasia of the hip, without significant safety concerns reported. ^{1 6 7 8 9}

How does the treatment intraoperative contrast-enhanced ultrasound (CEUS) for hip dysplasia differ from other treatments?

Intraoperative contrast-enhanced ultrasound (CEUS) is unique because it allows real-time assessment of blood flow to the femoral head during surgery, which can help prevent complications like avascular necrosis (tissue death due to lack of blood). This is different from traditional methods like MRI, which are used postoperatively and do not provide immediate feedback during surgery. ^{1 3 5 10 11}

Research Team

Susan J Back, MD

Principal Investigator

Children's Hospital of Philadelphia

Wudbhav N. Sankar, MD

Principal Investigator

Children's Hospital of Philadelphia

Eligibility Criteria

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.

Inclusion Criteria

I am a child aged between 4 months and 24 months.

Informed consent

I have tried non-surgical treatments without success and am now scheduled for a specific type of bone realignment and casting.

Exclusion Criteria

I do not have serious heart or lung conditions as listed for Lumason.

I am older than 24 months at the time of my surgery.

Parental/guardian permission (informed consent) and if appropriate, child assent.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Infants undergo intraoperative open or closed hip reduction with contrast-enhanced ultrasound to assess femoral head perfusion

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including comparison of CEUS with postoperative imaging and long-term radiographs

Approximately 3 years

Treatment Details

Interventions

• Intraoperative contrast-enhanced ultrasound (CEUS)
• Lumason

Trial Overview 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.

Participant Groups

Group I: DDH Surgical Reduction Patients Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

Pediatric Orthopaedic Society of North America

Collaborator

Trials

8

Recruited

1,500+

Bracco Diagnostics, Inc

Industry Sponsor

Trials

62

Recruited

9,500+

Diana Bracco

Bracco Diagnostics, Inc

Chief Executive Officer since 1999

Degree in Chemistry from the University of Pavia

Alberto Spinazzi

Bracco Diagnostics, Inc

Chief Medical Officer since 2023

MD

Findings from Research

Contrast-enhanced ultrasound (CEUS) is a feasible intraoperative method for assessing blood flow in the femoral head during hip reduction surgery for developmental dysplasia of the hip (DDH), based on a study of 17 patients.

The study found that CEUS effectively demonstrated blood flow before and after the surgical reduction, showing promise as an alternative to postoperative gadolinium-enhanced MRI for evaluating hip perfusion and potentially predicting avascular necrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative Contrast-Enhanced Ultrasound Imaging of Femoral Head Perfusion in Developmental Dysplasia of the Hip: A Feasibility Study. Back, SJ., Chauvin, NA., Ntoulia, A., et al.[2020]

The study emphasizes the importance of standardized ultrasound evaluation for congenital hip dysplasia, highlighting the coronal plane as the gold standard for assessing hip morphology and dynamics.

Ultrasound plays a crucial role in diagnosing and monitoring hip anomalies in collaboration with pediatric orthopedic surgeons, and it is also beneficial for evaluating painful hip conditions in children alongside other imaging techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Echography of the hip and other imaging techniques in pediatrics]. Devred, P., Tréguier, C., Ducou-Le-Pointe, H.[2016]

Hip sonography using the Graf technique is effective in detecting early cases of developmental dysplasia of the hip (DDH) and has significantly reduced the need for surgical interventions in Germany and Austria, with rates dropping to 1 in 4000 and 0.23 per thousand, respectively.

The implementation of ultrasound screening has led to a one-third reduction in overall treatment costs compared to the period before ultrasound was used, highlighting its value as a preventive tool in managing hip dysplasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hip sonography: 20 years experience and results. Graf, R.[2017]

In a study of 4782 newborns screened with hip ultrasonography, 9.9% were found to have developmental dysplasia of the hip (DDH), with higher prevalence in firstborn and female infants.

Treatment with Pavlik harnesses showed effective recovery times, averaging 12.5 weeks for more severe cases (type IIc and D) and 8.6 weeks for milder cases (type IIa(-)), highlighting the importance of early detection through hip ultrasound.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a universal ultrasonographic hip screening program at a single institution. Güler, O., Şeker, A., Mutlu, S., et al.[2022]

In a study of 3,400 infants with 6,800 hips examined using both morphological (Graf) and dynamic (Harcke) ultrasound methods, 81.47% were classified as normal (Type 1), indicating a high prevalence of normal hip development.

The combination of morphological and dynamic ultrasound methods can help reduce overtreatment and delayed treatment of developmental dysplasia of the hip (DDH), as it allows for better differentiation between stable and unstable hips, with 91.48% of Type 1 hips being stable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of morphologic and dynamic US methods in examination of the newborn hip. Koşar, P., Ergun, E., Unlübay, D., et al.[2016]

Ultrasound examination proved to be a more accurate method for diagnosing hip dislocation in 272 patients at risk, with only one equivocal result compared to six equivocal cases in radiographic evaluations.

The study found that ultrasound is a safe, non-invasive, and effective tool for assessing hip dysplasia, leading to its preference over traditional radiographic methods due to its lack of ionizing radiation and ability to provide dynamic assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound compared with radiographic assessment in developmental dysplasia of the hip. McEvoy, A., Paton, RW.[2016]

During the COVID-19 lockdown, ultrasound screening for developmental dysplasia of the hip (DDH) was significantly reduced, with one center screening only 78% of patients compared to the previous year, leading to delays in diagnosis and treatment.

In one center, 28 patients were diagnosed late with DDH at an average age of 114 days, compared to only 8 patients diagnosed late in the same period the previous year, highlighting the impact of the pandemic on timely medical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developmental dysplasia of the hip screening during the lockdown for COVID-19: experience from Northern Italy. Guindani, N., De Pellegrin, M.[2022]

The use of anterior ultrasound (USS) in addition to lateral USS for assessing developmental dysplasia of the hip (DDH) led to a significantly shorter treatment duration for patients, averaging 53.3 days compared to 66.2 days with lateral USS alone.

Anterior USS also improved the ability to identify hips that failed to stabilize after reduction, allowing for earlier intervention, while maintaining a similar failure rate of treatment between the two methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Verification of hip reduction using anterior ultrasound scanning during Pavlik harness treatment of developmental dysplasia of the hip. Carlile, GS., Woodacre, T., Cox, PJ.[2020]

In a study of 21,676 newborns, early universal ultrasound screening for developmental dysplasia of the hip (DDH) identified 0.6% of infants with pathological hips, allowing for timely intervention.

The screening program significantly reduced the need for treatment (only 0.26% required an orthosis) and minimized the rates of surgical procedures and late-detected cases of DDH, highlighting its efficacy in managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early neonatal universal ultrasound screening for developmental dysplasia of the hip: a single institution observational study. Treiber, M., Korpar, B., Sirše, M., et al.[2021]

Ultrasound has become the primary method for early diagnosis of hip dysplasia due to its non-invasive nature, ability to be performed at a very young age, and repeatability, making it a valuable tool for timely intervention.

In a study of 1500 patients (3000 hips), ultrasound demonstrated effectiveness in diagnosing and monitoring hip dysplasia, particularly in guiding conservative treatments like the Hoffmann-Pipino harness for congenital dislocation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound for early diagnosis of hip dysplasia. Franchin, F., Lacalendola, G., Molfetta, L., et al.[2016]

3D ultrasound (3DUS) significantly improves the reliability and accuracy of diagnosing developmental dysplasia of the hip (DDH) compared to 2D ultrasound (2DUS), especially for novice operators with limited training.

Novice operators using 3DUS achieved a diagnostic accuracy of 98% in classifying infant hips, demonstrating that 3DUS can be effectively performed by less experienced users, while 2DUS showed poor reliability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability of 2D and 3D ultrasound for infant hip dysplasia in the hands of novice users. Mostofi, E., Chahal, B., Zonoobi, D., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Intraoperative Contrast-Enhanced Ultrasound Imaging of Femoral Head Perfusion in Developmental Dysplasia of the Hip: A Feasibility Study. [2020]

2. France pubmed.ncbi.nlm.nih.gov

[Echography of the hip and other imaging techniques in pediatrics]. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Hip sonography: 20 years experience and results. [2017]

4. Turkey pubmed.ncbi.nlm.nih.gov

Results of a universal ultrasonographic hip screening program at a single institution. [2022]

5. Turkey pubmed.ncbi.nlm.nih.gov

Comparison of morphologic and dynamic US methods in examination of the newborn hip. [2016]

6. Scotland pubmed.ncbi.nlm.nih.gov

Ultrasound compared with radiographic assessment in developmental dysplasia of the hip. [2016]

7. England pubmed.ncbi.nlm.nih.gov

Developmental dysplasia of the hip screening during the lockdown for COVID-19: experience from Northern Italy. [2022]

8. India pubmed.ncbi.nlm.nih.gov

Verification of hip reduction using anterior ultrasound scanning during Pavlik harness treatment of developmental dysplasia of the hip. [2020]

9. Germany pubmed.ncbi.nlm.nih.gov

Early neonatal universal ultrasound screening for developmental dysplasia of the hip: a single institution observational study. [2021]

10. Italy pubmed.ncbi.nlm.nih.gov

Ultrasound for early diagnosis of hip dysplasia. [2016]

11. Germany pubmed.ncbi.nlm.nih.gov

Reliability of 2D and 3D ultrasound for infant hip dysplasia in the hands of novice users. [2020]