Developmental Dysplasia of the HipEarly Phase 1NCT03107520
Intraoperative Contrast-Enhanced Ultrasound Evaluation of Blood Flow at the Time of Surgical Hip Reduction for DDH
A Early Phase 1 study testing Intraoperative contrast-enhanced ultrasound (CEUS) and Lumason in people with Developmental Dysplasia of the Hip, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 24 months
- Conditions the study is for
- Developmental Dysplasia of the Hip
- What is being tested?
- Intraoperative contrast-enhanced ultrasound (CEUS) and Lumason
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2017to Apr 2030
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- > 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19014
Wudbhav N. Sankar, MD, 215-590-1527, sankarw@chop.edu
About this study
Official title: Use of Intraoperative Contrast-enhanced Ultrasound to Evaluate Femoral Head Perfusion in Infants With Developmental Dysplasia of the Hip at the Time of Surgical Reduction
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.
Read the 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.
- Conditions
- Developmental Dysplasia of the Hip
- Being tested
- Intraoperative contrast-enhanced ultrasound (CEUS), Lumason
- Keywords
- contrast-enhanced ultrasound, Lumason, developmental dysplasia of the hip (DDH), avascular necrosis
- Medical subject headings
- Developmental Dysplasia of the Hip, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative contrast-enhanced ultrasound (CEUS)Diagnostic test
An intraoperative CEUS of the dysplastic femoral head will be performed after surgical reduction of the femoral head and during placement of the spica cast.
LumasonDrug
Administration of Lumason contrast agent to improve visualization of epiphyseal vascularity in the femoral head.
| Study group | Role | What they receive |
|---|---|---|
| DDH Surgical Reduction Patients | Experimental | 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. Receives: Diagnostic Test: Intraoperative contrast-enhanced ultrasound (CEUS); Drug: Lumason |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visualization of epiphyseal vascularity in the femoral head
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.
Measured: 1 day
Secondary outcomes (2)
Comparison of CEUS and Post-Operative Imaging
The images obtained via intraoperative CEUS will be compared to standard-of-care postoperative perfusion MR imaging and 1-year follow-up radiographs.
Measured: Approximately 3 years
Estimate and predict the likelihood of developing avascular necrosis
To estimate the relationship and predict the likelihood of developing avascular necrosis (outcome variable) and CEUS performance (explanatory variable) as measured by CEUS score
Measured: Approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start22 May 2017
- Primary completionApr 2027 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Developmental Dysplasia of the HipStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Bracco Diagnostics, Inc, Pediatric Orthopaedic Society of North America
- Responsible party
- Sponsor
- Investigators
- Wudbhav N Sankar, MD, Principal investigator, Children's Hospital of PhiladelphiaSusan Back, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107520
- Sponsor's protocol ID
- 16-013583
- Status last verified
- Apr 2026
- First submitted
- 23 Mar 2017
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Darge K, Papadopoulou F, Ntoulia A, Bulas DI, Coley BD, Fordham LA, Paltiel HJ, McCarville B, Volberg FM, Cosgrove DO, Goldberg BB, Wilson SR, Feinstein SB. 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). Pediatr Radiol. 2013 Sep;43(9):1063-73. doi: 10.1007/s00247-013-2746-6. Epub 2013 Jul 11.
PubMed 23843130Rosenbaum DG, Servaes S, Bogner EA, Jaramillo D, Mintz DN. MR Imaging in Postreduction Assessment of Developmental Dysplasia of the Hip: Goals and Obstacles. Radiographics. 2016 May-Jun;36(3):840-54. doi: 10.1148/rg.2016150159. Epub 2016 Apr 1.
PubMed 27035836Tiderius C, Jaramillo D, Connolly S, Griffey M, Rodriguez DP, Kasser JR, Millis MB, Zurakowski D, Kim YJ. Post-closed reduction perfusion magnetic resonance imaging as a predictor of avascular necrosis in developmental hip dysplasia: a preliminary report. J Pediatr Orthop. 2009 Jan-Feb;29(1):14-20. doi: 10.1097/BPO.0b013e3181926c40.
PubMed 19098638Gornitzky AL, Georgiadis AG, Seeley MA, Horn BD, Sankar WN. Does Perfusion MRI After Closed Reduction of Developmental Dysplasia of the Hip Reduce the Incidence of Avascular Necrosis? Clin Orthop Relat Res. 2016 May;474(5):1153-65. doi: 10.1007/s11999-015-4387-6.
PubMed 26092677
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Intraoperative Contrast-enhanced Ultrasound to Evaluate Femoral Head Perfusion in Infants With Developmental Dysplasia of the Hip at the Time of Surgical Reduction
- ClinicalTrials.gov ID
- NCT03107520
- Acronym / sponsor ID
- 16-013583
- Conditions
- Developmental Dysplasia of the Hip
- Keywords
- contrast-enhanced ultrasound, Lumason, developmental dysplasia of the hip (DDH), avascular necrosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Bracco Diagnostics, Inc, Pediatric Orthopaedic Society of North America
- Study start
- 22 May 2017 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 11 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DDH Surgical Reduction Patients | Experimental | Diagnostic Test: Intraoperative contrast-enhanced ultrasound (CEUS), Drug: LumasonInfants 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 may qualify
- Ages
- 4 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- > 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative contrast-enhanced ultrasound (CEUS)An intraoperative CEUS of the dysplastic femoral head will be performed after surgical reduction of the femoral head and during placement of the spica cast. | Diagnostic test | DDH Surgical Reduction Patients |
| LumasonAdministration of Lumason contrast agent to improve visualization of epiphyseal vascularity in the femoral head. | Drug | DDH Surgical Reduction Patients |
Primary outcome
Visualization of epiphyseal vascularity in the femoral head
Time frame: 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.
2 secondary outcomes
Comparison of CEUS and Post-Operative Imaging
Time frame: Approximately 3 years
Estimate and predict the likelihood of developing avascular necrosis
Time frame: Approximately 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Background: PubMed 23843130Darge K, Papadopoulou F, Ntoulia A, Bulas DI, Coley BD, Fordham LA, Paltiel HJ, McCarville B, Volberg FM, Cosgrove DO, Goldberg BB, Wilson SR, Feinstein SB. 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). Pediatr Radiol. 2013 Sep;43(9):1063-73. doi: 10.1007/s00247-013-2746-6. Epub 2013 Jul 11.
- Background: PubMed 27035836Rosenbaum DG, Servaes S, Bogner EA, Jaramillo D, Mintz DN. MR Imaging in Postreduction Assessment of Developmental Dysplasia of the Hip: Goals and Obstacles. Radiographics. 2016 May-Jun;36(3):840-54. doi: 10.1148/rg.2016150159. Epub 2016 Apr 1.
- Background: PubMed 19098638Tiderius C, Jaramillo D, Connolly S, Griffey M, Rodriguez DP, Kasser JR, Millis MB, Zurakowski D, Kim YJ. Post-closed reduction perfusion magnetic resonance imaging as a predictor of avascular necrosis in developmental hip dysplasia: a preliminary report. J Pediatr Orthop. 2009 Jan-Feb;29(1):14-20. doi: 10.1097/BPO.0b013e3181926c40.
- Background: PubMed 26092677Gornitzky AL, Georgiadis AG, Seeley MA, Horn BD, Sankar WN. Does Perfusion MRI After Closed Reduction of Developmental Dysplasia of the Hip Reduce the Incidence of Avascular Necrosis? Clin Orthop Relat Res. 2016 May;474(5):1153-65. doi: 10.1007/s11999-015-4387-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wudbhav N Sankar, MD principal investigator
Children's Hospital of Philadelphia
Susan Back, MD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Intraoperative contrast-enhanced ultrasound (CEUS) and Lumason in people with Developmental Dysplasia of the Hip, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wudbhav N Sankar, MD (215-590-1527, sankarw@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visualization of epiphyseal vascularity in the femoral head (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03107520, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.