Intraoperative Contrast-Enhanced Ultrasound Evaluation of Blood Flow at the Time of Surgical Hip Reduction for DDH

NCT03107520 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 16-013583
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Developmental Dysplasia of the Hip

Keywords

contrast-enhanced ultrasound; Lumason; developmental dysplasia of the hip (DDH); avascular necrosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Comparison of CEUS and Post-Operative Imaging

  Approximately 3 years

• Estimate and predict the likelihood of developing avascular necrosis

  Approximately 3 years

Study Arms (1)

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.

Diagnostic Test: Intraoperative contrast-enhanced ultrasound (CEUS); Drug: Lumason

Interventions

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.

DDH Surgical Reduction Patients

Lumason DRUG

Administration of Lumason contrast agent to improve visualization of epiphyseal vascularity in the femoral head.

DDH Surgical Reduction Patients

Eligibility Criteria

• Age: 4 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• \> 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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Bracco Diagnostics, Inc: collaborator
• Pediatric Orthopaedic Society of North America: collaborator

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19014, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 23843130 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.

  PMID: 27035836 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.

  PMID: 19098638 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.

  PMID: 26092677 BACKGROUND

MeSH Terms

Conditions

Developmental Dysplasia of the Hip; Osteonecrosis

Condition Hierarchy (Ancestors)

Hip Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wudbhav N Sankar, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

• Susan Back, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wudbhav N Sankar, MD

CONTACT

215-590-1527; sankarw@chop.edu

Susan Back, MD

CONTACT

215-590-7000; backs@chop.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: April 11, 2017
• Study Start: May 22, 2017
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2030
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)