Using ultrasound to assess blood flow during hip surgery for infants with hip dysplasia
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
This study is testing if using a special ultrasound during hip surgery can help doctors see blood flow in infants with hip dysplasia to prevent complications and improve surgery results.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 4 Months to 24 Months |
| Sex | All |
| Sponsor | Children's Hospital of Philadelphia Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT03107520 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of using contrast-enhanced ultrasound (CEUS) to assess blood flow to the femoral head in infants undergoing surgical reduction for developmental dysplasia of the hip (DDH). The approach aims to provide real-time insights during surgery, potentially reducing the risk of avascular necrosis, a common complication. By utilizing CEUS, the study seeks to improve surgical outcomes by identifying intraoperative factors that may contribute to blood flow issues. The intervention involves administering Lumason, a contrast agent, during the surgical procedure.
Who should consider this trial
Good fit: Ideal candidates are infants aged 4 to 24 months diagnosed with developmental dysplasia of the hip who require surgical intervention after failed conservative treatment.
Not a fit: Patients older than 24 months or those successfully treated with conservative measures will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of avascular necrosis in infants undergoing hip surgery.
How similar studies have performed: While there is emerging evidence supporting the use of gadolinium-enhanced MR studies postoperatively, the use of CEUS in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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, 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.
Where this trial is running
Philadelphia, Pennsylvania
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Wudbhav N Sankar, MD — Children's Hospital of Philadelphia
- Study coordinator: Wudbhav N Sankar, MD
- Email: sankarw@chop.edu
- Phone: 215-590-1527
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.