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Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction Following Oral Squamous Cell Carcinoma Resection and Drugs-induced Osteonecrosis

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Study sites: 15 to 19v19
  2. Eligibility criteria expanded, about 65 words
    • Site contacts updated at 2 of 15 sites
    • Study description expanded, about 3 words
    • Study title expanded, about 3 words
    v18
  3. Re-verified, no change to tracked fieldsv17
  4. Study sites: 14 to 15v16
  5. Site details revised at 2 of 14 sitesv15
Show 13 earlier versionsHide 13 earlier versions
  1. Primary completion date: Jan 31, 2027 to Jun 30, 2030
    • Study sites: 13 to 14
    • Study completion date: Dec 31, 2028 to Dec 31, 2030
    v14
  2. Primary completion date: Jan 31, 2025 to Jan 31, 2027
    • Study sites: 11 to 13
    • Study completion date: Dec 31, 2025 to Dec 31, 2028
    v13
  3. Site details revised at 7 of 11 sitesv12
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 12 to 11
    • Start date changed from estimate of Jul 15, 2022 to Sep 12, 2022
    v11
  5. Start date: Mar 1, 2022 to Jul 15, 2022v10
  6. Start date: Jan 1, 2022 to Mar 1, 2022v9
  7. Lead sponsor: AO Clinical Investigation and Publishing Documentation to AO Innovation Translation Center
    • Study sites: 14 to 12
    v8
  8. Start date: Oct 1, 2021 to Jan 1, 2022v7
  9. Start date: Jul 1, 2021 to Oct 1, 2021v6
  10. Re-verified, no change to tracked fieldsv5
  11. Start date: Jun 1, 2021 to Jul 1, 2021
    • Study sites: 0 to 14
    v4
  12. Start date: Dec 31, 2020 to Jun 1, 2021v3
  13. Start date: Jan 31, 2020 to Dec 31, 2020v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 will be collected in a minimum of 300 patients presenting with an acquired segmental mandibular defect ≥ 2 cm secondary to OSSC removal and drugs-induced osteonecrosis, and who require mandibular reconstruction.
Trial Details
NCT Number NCT04098146
Lead Sponsor AO Innovation Translation Center
Conditions
(from sponsor)		 Mandibular Reconstruction, Segmental Mandibular Defects
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov