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AMIStem Primary Hip System Prospective Post-marketing Multi-centre Surveillance Study

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv14
  2. Primary and study completion dates: Feb 2028 to Jan 2028 Start date: Feb 2010 to Jan 2010v13 Show 1 more changeShow less
    • Start date: Feb 2010 to Jan 2010
  3. 3 versions Re-verified since Feb 19, 2020, no change to tracked fieldsv10-v12
  4. Primary completion date: Sep 2017 to Feb 2028 Primary endpoint revised · Trial status: Recruiting to Active, Not Recruiting · Completion date: Sep 2027 to Feb 2028 · 2 morev9 Show 5 more changesShow less
    • Primary endpoint revised
    • Trial status: Recruiting to Active, Not Recruiting
    • Completion date: Sep 2027 to Feb 2028
    • Secondary endpoints revised (4)
    • Site details revised at 2 of 2 sites

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion date: Sep 2016 to Sep 2017 Completion date: Mar 2026 to Sep 2027v8 Show 1 more changeShow less
    • Completion date: Mar 2026 to Sep 2027
Show 6 earlier versionsHide 6 earlier versions
  1. Primary completion date: Feb 2024 to Sep 2016 Completion date: Feb 2024 to Mar 2026 · Study arms: 0 to 1v7 Show 2 more changesShow less
    • Completion date: Feb 2024 to Mar 2026
    • Study arms: 0 to 1
  2. 2 versions Re-verified since Jan 10, 2012, no change to tracked fieldsv5-v6
  3. Primary and study completion dates: Feb 2022 to Feb 2024v4
  4. Re-verified, no change to tracked fieldsv3
  5. Primary endpoint revised Secondary endpoints revised (4)v2 Show 1 more changeShow less
    • Secondary endpoints revised (4)

    See this version in full on ClinicalTrials.gov ↗

  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a multicentre post-marketing prospective study to evaluate performance and clinical outcomes of AMIIStem primary hip system.
Trial Details
NCT Number NCT01107340
Lead Sponsor Medacta International SA
Conditions Osteoarthritis, Arthritis, Avascular Necrosis, Fracture of the Femoral Neck or Head, Congenital Hip Dysplasia
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov