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An International, Multicenter, Prospective Registry on Post-traumatic Long Bones Defects

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 20 to 21v16
  2. Study sites: 19 to 20v15
  3. Study sites: 18 to 19v14
  4. Study sites: 19 to 18v13
  5. Site details revised at 4 of 19 sitesv12
Show 10 earlier versionsHide 10 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 8 to 19
    • Start date changed from estimate of Apr 30, 2024 to Jul 3, 2024
    v11
  2. Primary completion date: Jul 31, 2025 to May 31, 2028
    • Start date: Jul 31, 2023 to Apr 30, 2024
    • Study completion date: Mar 30, 2026 to Mar 30, 2029
    v10
  3. Start date: Nov 15, 2022 to Jul 31, 2023v9
  4. Start date: Sep 15, 2022 to Nov 15, 2022v8
  5. Re-verified, no change to tracked fieldsv7
  6. Start date: Sep 15, 2021 to Sep 15, 2022v6
  7. Study sites: 0 to 8v5
  8. Start date: Jun 15, 2021 to Sep 15, 2021v4
  9. Start date: Dec 15, 2020 to Jun 15, 2021v3
  10. Lead sponsor: AO Clinical Investigation and Publishing Documentation to AO Innovation Translation Center
    • Primary completion date: Oct 31, 2024 to Jul 31, 2025
    • Start date: Mar 31, 2020 to Dec 15, 2020
    • Study completion date: Jun 30, 2025 to Mar 30, 2026
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Long bone defect (LBD) is defined as a focalized loss of bone tissue in any long bone of the upper or lower extremity. Long bone defects are a complex problem, that may arise as a complication of many different pathologies, such as trauma, tumors or infection. Whereas post-traumatic defects are the largest group. Reports estimate that there are almost 4 million bone grafting procedures worldwide per year. However, limb reconstruction in the context of a bony defect is challenging and up to date there is little evidence and treatment recommendations. In a multi-national approach, the aim of this project is to set up an international, multicenter registry to gather information and details on prevalence or incidence, current treatments, complications and outcome.
Trial Details
NCT Number NCT04112992
Lead Sponsor AO Innovation Translation Center
Conditions
(from sponsor)		 Limb Fracture, Bone Loss
Related terms Bone Diseases, Metabolic
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov