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

Primary Purpose

Developmental Dysplasia of the Hip

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Intraoperative contrast-enhanced ultrasound (CEUS)

Lumason

About this trial

This is an interventional diagnostic trial for Developmental Dysplasia of the Hip focused on measuring contrast-enhanced ultrasound, Lumason, developmental dysplasia of the hip (DDH), avascular necrosis

Eligibility Criteria

4 Months - 24 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 and are undergoing closed or open reduction and spica casting.
Informed consent

Exclusion Criteria:

> 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.

Sites / Locations

The Children's Hospital of PhiladelphiaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DDH Surgical Reduction Patients

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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

Full Information

NCT ID

NCT03107520

First Posted

March 23, 2017

Last Updated

May 18, 2023

Sponsor

Children's Hospital of Philadelphia

Collaborators

Bracco Diagnostics, Inc

1. Study Identification

Unique Protocol Identification Number

NCT03107520

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 22, 2017 (Actual)

Primary Completion Date

April 2025 (Anticipated)

Study Completion Date

April 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Hospital of Philadelphia

Collaborators

Bracco Diagnostics, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Developmental Dysplasia of the Hip

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Masking Description

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.

Allocation

N/A

Enrollment

125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DDH Surgical Reduction Patients

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

Intraoperative contrast-enhanced ultrasound (CEUS)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Lumason

Intervention Description

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

Primary Outcome Measure Information:

Title

Visualization of epiphyseal vascularity in the femoral head

Description

Time Frame

1 day

Secondary Outcome Measure Information:

Title

Comparison of CEUS and Post-Operative Imaging

Description

The images obtained via intraoperative CEUS will be compared to standard-of-care postoperative perfusion MR imaging and 1-year follow-up radiographs.

Time Frame

Approximately 3 years

Title

Estimate and predict the likelihood of developing avascular necrosis

Description

To estimate the relationship and predict the likelihood of developing avascular necrosis (outcome variable) and CEUS performance (explanatory variable) as measured by CEUS score

Time Frame

Approximately 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Months

Maximum Age & Unit of Time

24 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 and are undergoing closed or open reduction and spica casting. Informed consent Exclusion Criteria: > 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wudbhav N Sankar, MD

Phone

215-590-1527

sankarw@chop.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Susan Back, MD

Phone

215-590-7000

backs@chop.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wudbhav N Sankar, MD

Organizational Affiliation

Children's Hospital of Philadelphia

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Susan Back, MD

Organizational Affiliation

Children's Hospital of Philadelphia

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Children's Hospital of Philadelphia

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19014

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wudbhav N. Sankar, MD

Phone

215-590-1527

sankarw@chop.edu

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23843130

Citation

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.

Results Reference

background

PubMed Identifier

27035836

Citation

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.

Results Reference

background

PubMed Identifier

19098638

Citation

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.

Results Reference

background

PubMed Identifier

26092677

Citation

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.

Results Reference

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

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