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| Name | Class |
|---|---|
| Bracco Diagnostics, Inc | INDUSTRY |
| Pediatric Orthopaedic Society of North America | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Approximately 3 years |
| Estimate and predict the likelihood of developing avascular necrosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wudbhav N Sankar, MD | Contact | 215-590-1527 | sankarw@chop.edu | |
| Susan Back, MD | Contact | 215-590-7000 | backs@chop.edu |
| Name | Affiliation | Role |
|---|---|---|
| Wudbhav N Sankar, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Susan Back, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19014 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23843130 | Background | 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. | |
| 27035836 |
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The surgeon and musculoskeletal radiologist administering the contrast-enhanced ultrasound will not be blinded at the time of the intervention; however, they will be blinded when comparing the results of the CEUS to standard-of-care perfusion MRI and 3-years postop radiographs.
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| Lumason | Drug | Administration of Lumason contrast agent to improve visualization of epiphyseal vascularity in the femoral head. |
|
To estimate the relationship and predict the likelihood of developing avascular necrosis (outcome variable) and CEUS performance (explanatory variable) as measured by CEUS score |
| Approximately 3 years |
| Background |
| Rosenbaum 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. |
| 19098638 | Background | Tiderius 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. |
| 26092677 | Background | Gornitzky 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. |
| ID | Term |
|---|---|
| D000082602 | Developmental Dysplasia of the Hip |
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D006617 | Hip Dislocation |
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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