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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to assess blood flow in babies with hip dysplasia, a condition where the hip joint doesn't develop correctly. During surgery, doctors use a special type of ultrasound called intraoperative contrast-enhanced ultrasound (CEUS) with a contrast agent to observe blood movement in the hip, aiding the procedure. The trial targets infants who haven't improved with other treatments and require surgery to correct their hips. To qualify, the baby must be between 4 and 24 months old and have a diagnosis of hip dysplasia needing surgical intervention. As an Early Phase 1 trial, this research aims to understand how this innovative ultrasound technique works in infants, offering a unique opportunity to contribute to medical advancements.

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 prior data suggests that contrast-enhanced ultrasound is safe for infants undergoing surgical reduction for hip dysplasia?

Research has shown that using contrast-enhanced ultrasound (CEUS) during surgery is generally safe and well-tolerated. Studies have found that it provides real-time images without harmful radiation, making it a safer option for pediatric surgeries. No major side effects have been reported, particularly because the contrast agent, such as Lumason, enhances image clarity. This trial is in the early stages and primarily aims to test the safety and effectiveness of CEUS for assessing blood flow in infants with hip dysplasia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for developmental dysplasia of the hip (DDH), which often involves surgical reduction followed by imaging methods like X-rays or MRIs to assess hip joint placement, intraoperative contrast-enhanced ultrasound (CEUS) offers real-time insight into blood flow to the hip joint. Researchers are excited about this technique because it uses Lumason, a special contrast agent, to enhance ultrasound images, making it easier to visualize the vascularity of the hip during surgery. This could potentially improve surgical outcomes by ensuring better positioning and stabilization of the hip joint right then and there, reducing the need for additional interventions.

What evidence suggests that intraoperative contrast-enhanced ultrasound (CEUS) is effective for assessing blood flow in hip dysplasia?

In this trial, infants undergoing intraoperative open or closed hip reduction for developmental dysplasia of the hip (DDH) will receive contrast-enhanced ultrasound (CEUS) with the Lumason contrast agent. Studies have shown that CEUS effectively checks blood flow during hip surgery for DDH. This method allows surgeons to see how well blood moves to the femoral head, the top part of the thigh bone. Research indicates that CEUS is promising because it provides clear images and helps ensure proper hip alignment after surgery. The Lumason contrast agent used in CEUS is known for its safety and effectiveness in enhancing ultrasound images. Overall, these findings suggest that CEUS can be a useful and reliable tool during hip surgeries in infants with DDH. ^{1 2 4 6 7}

Who Is on the Research Team?

Susan J Back, MD

Principal Investigator

Children's Hospital of Philadelphia

Wudbhav N. Sankar, MD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

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.

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

Informed consent

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31334874/

Intraoperative Contrast-Enhanced Ultrasound Imaging of ... Contrast-enhanced ultrasound is a feasible intraoperative tool for assessing adequate blood flow after hip reduction surgery in DDH.

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/jum.15097

Intraoperative Contrast‐Enhanced Ultrasound Imaging of ... As contrast-enhanced ultrasound (CEUS) assesses blood flow in real time, it may be an effective intraoperative alternative to evaluate femoral ...

3. pure.psu.edu pure.psu.edu/en/publications/intraoperative-contrast-enhanced-ultrasound-imaging-of-femoral-he

Intraoperative Contrast-Enhanced Ultrasound Imaging of ... Objectives: Developmental dysplasia of the hip (DDH) is one of the most common developmental deformities of the lower extremity.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301562924003028

The Role of Contrast-enhanced Ultrasound in the Femoral ... CEUS proves to be a promising technique for quantitatively detecting FH perfusion in DDH and SAH infants with high reproducibility.

5. ovid.com ovid.com/journals/jultm/pdf/10.1002/jum.15097~intraoperative-contrastenhanced-ultrasound-imaging-of

Intraoperative contrast-enhanced ultrasound of femoral ... Conclusions—Contrast-enhanced ultrasound is a feasible intraoperative tool for assessing adequate blood flow after hip reduction surgery in DDH. Key Words— ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/jcu.24096?af=R

Intraoperative Contrast‐Enhanced Ultrasonography in ... Intraoperative CEUS is a safe and feasible tool in pediatric surgeries, providing real-time visualization without ionizing radiation.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40616173/

A Review of Techniques, Applications, and Outcomes Contrast-enhanced ultrasound (CEUS) utilizes microbubble contrast agents to improve imaging clarity during surgeries, offering real-time ...