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

StatusRecruiting
PhaseEarly Phase 1
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv14
  2. Primary completion date: Apr 2025 to Apr 2027
    • Study completion date: Apr 2028 to Apr 2030
    • Eligibility criteria expanded, about 19 words
    v13
  3. Collaborators: 1 to 2v12
  4. Secondary endpoints: 1 to 2v11
  5. Primary completion date: Apr 2024 to Apr 2025
    • Study completion date: Apr 2027 to Apr 2028
    • Eligibility criteria expanded, about 64 words
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Enrollment target: 35 to 125v9 Show 5 more changesShow less
    • Primary completion date: Apr 2022 to Apr 2024
    • Study completion date: Apr 2022 to Apr 2027
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study title expanded, about 3 words
  2. Trial status: Active, Not Recruiting to Recruiting
    • Primary and study completion dates: Apr 2021 to Apr 2022
    • Site details revised
    v8
  3. Primary and study completion dates: Apr 2020 to Apr 2021
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v7
  4. Primary completion date: Apr 2019 to Apr 2020v6
  5. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v5
  6. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v4
  7. Primary completion date: Apr 10, 2019 to Apr 2019
    • Study completion date: Apr 10, 2020 to Apr 2020
    v3
  8. Start date: Apr 10, 2017 to May 22, 2017v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03107520
Lead Sponsor Children's Hospital of Philadelphia
Collaborators: Bracco Diagnostics, Inc, Pediatric Orthopaedic Society of North America
Conditions
(from sponsor)		 Developmental Dysplasia of the Hip
Related terms Developmental Dysplasia of the Hip, Osteonecrosis
Enrollment 125 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov