RECRUITING

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

Talk to us

Conditions

Developmental Dysplasia of the Hipcontrast-enhanced ultrasoundLumasondevelopmental dysplasia of the hip (DDH)avascular necrosis

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2017-05-22
Study Completion:2028-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03107520

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:4 Months to 24 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Males or females between 4 months and up to and including 24 months of age at the time of surgery.
  2. * Diagnosed with DDH.
  3. * Failed conservative treatment and are undergoing closed or open reduction and spica casting.
  4. * Informed consent
  1. * \> 24 months of age at the time of surgery.
  2. * Subjects with DDH who are successfully treated with conservative measures and do not require surgical reduction.
  3. * Previous open hip reduction of the affected side
  4. * 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.
  5. * 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.

Contacts and Locations

Study Contact

Wudbhav N Sankar, MD
CONTACT
215-590-1527
sankarw@chop.edu
Susan Back, MD
CONTACT
215-590-7000
backs@chop.edu

Principal Investigator

Wudbhav N Sankar, MD
PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Susan Back, MD
PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia

Study Locations (Sites)

The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19014
United States

Collaborators and Investigators

Sponsor: Children's Hospital of Philadelphia

  • Wudbhav N Sankar, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia
  • Susan Back, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-05-22
Study Completion Date2028-04

Study Record Updates

Study Start Date2017-05-22
Study Completion Date2028-04

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Developmental Dysplasia of the Hip