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StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Enrollment target: 1130 to 1500
    • Secondary endpoints: 8 to 11
    v15
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 3500 to confirmed 1130
    • Eligibility criteria revised
    • Site details revised at 15 of 15 sites
    v14
  3. Study sites: 13 to 15v13
  4. Primary completion date: Oct 31, 2025 to Dec 31, 2026v12
  5. Study sites: 12 to 13v11
Show 9 earlier versionsHide 9 earlier versions
  1. Primary completion date: Jul 2023 to Oct 31, 2025
    • Study completion date: Dec 2023 to Dec 31, 2026
    v10
  2. Study sites revised (12)v9
  3. Start date changed from estimate of Feb 2021 to Feb 1, 2021v8
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Nov 2020 to Feb 2021
    • Site details revised at 12 of 12 sites
    v7
  5. Start date: Aug 2020 to Nov 2020v6
  6. Lead sponsor: AO Clinical Investigation and Publishing Documentation to AO Innovation Translation Center
    • Start date: May 2020 to Aug 2020
    v5
  7. Start date: Feb 2020 to May 2020v4
  8. Start date: Dec 2019 to Feb 2020v3
  9. Start date: Oct 2019 to Dec 2019v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Prospective data will be collected in approximately 3500 patients (700 per 5 injury groups). Patients will be followed up according to the standard (routine) for up to 1 year after the treatment. Data collection will include underlying disease, treatment details, patient reported outcomes (PROs), anticipated or procedure-related adverse events (i.e. complications), and radiological outcomes.
Trial Details
NCT Number NCT04113044
Lead Sponsor AO Innovation Translation Center
Conditions
(from sponsor)		 Hip Fractures, Tibial Fractures, Ankle Fractures, Humeral Fracture, Proximal, Distal Radius Fracture
Related terms Ankle Fractures, Hip Fractures, Shoulder Fractures, Tibial Fractures, Wrist Fractures
Enrollment 1,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov