Clinical Trial: Intraoperative Contrast-Enhanced Ultrasound Evaluation of Blood Flow After Surgical Hip Reduction for DDH

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Use of Intraoperative Contrast-Enhanced Ultrasound to Evaluate Femoral Head Perfusion in Infants With Developmental Hip Dysplasia After Surgical Reduction

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 Summary:

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.


Sponsor: Children's Hospital of Philadelphia

Current 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Comparison of CEUS and Post-Operative Imaging [ Time Frame: Approximately 1 year ]

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


Original Secondary Outcome: Same as current

Information By: Children's Hospital of Philadelphia

Dates:
Date Received: March 23, 2017
Date Started: May 22, 2017
Date Completion: April 10, 2020
Last Updated: April 12, 2017
Last Verified: April 2017