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

Children's Hospital of Philadelphia (CHOP)

Status and phase: Enrolling; Early Phase 1

Conditions: Developmental Dysplasia of the Hip

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03107520

16-013583

Details and patient eligibility

About

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.

Full 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.

Enrollment: 125 estimated patients

Sex: All

Ages: 4 to 24 months old

Volunteers: No 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, 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)

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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125 participants in 1 patient group

DDH Surgical Reduction Patients

Experimental group

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.

Treatment:

Drug: Lumason

Diagnostic Test: Intraoperative contrast-enhanced ultrasound (CEUS)