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Zimmer Continuum Metal on Polyethylene (MoP) PostMarket Clinical Followup (PMCF) Study

StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary endpoints: details revised at 1 of 2 entries Trial completed · Enrollment increased: 165 → 195 participants · Primary completion date changed from estimate of Dec 2027 to Jul 17, 2026 · 2 more Show 5 more changesShow less
    • Trial completed
    • Enrollment increased: 165 → 195 participants
    • Primary completion date changed from estimate of Dec 2027 to Jul 17, 2026
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints: details revised at 4 of 4 entries
  2. Minor Re-verified, no change to tracked fieldsv23
  3. Notable Primary completion date: Mar 2024 to Dec 2027 Completion date: Dec 2024 to Dec 2027v22 Show 1 more changeShow less
    • Completion date: Dec 2024 to Dec 2027
  4. Notable Primary endpoints: 1 to 2 Enrollment target: estimated 300 to confirmed 165 · Secondary endpoints: 1 to 4v21 Show 2 more changesShow less
    • Enrollment target: estimated 300 to confirmed 165
    • Secondary endpoints: 1 to 4

    See this version in full on ClinicalTrials.gov ↗

  5. Minor 4 versions Re-verified since Mar 26, 2020, no change to tracked fieldsv17-v20
Show 15 earlier versionsHide 15 earlier versions
  1. Minor Start date: Mar 2012 to Mar 29, 2011v16
  2. Minor 2 versions Re-verified since Feb 6, 2019, no change to tracked fieldsv14-v15
  3. Notable Primary endpoint revised Trial status: Recruiting to Active, Not Recruiting · Interventions: Continuum(R) Metal on Polyethylene Acetabular System (Device) to Continuum Metal on Polyethylene Acetabular System (Device) · Eligibility criteria expanded, about 225 words · 2 morev13 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Interventions: Continuum(R) Metal on Polyethylene Acetabular System (Device) to Continuum Metal on Polyethylene Acetabular System (Device)
    • Eligibility criteria expanded, about 225 words
    • Secondary endpoint revised
    • Study sites revised (2)

    See this version in full on ClinicalTrials.gov ↗

  4. Notable Start date: Mar 2011 to Mar 2012 Primary completion date: Dec 2024 to Mar 2024 · Site details revised at 1 of 2 sitesv12 Show 2 more changesShow less
    • Primary completion date: Dec 2024 to Mar 2024
    • Site details revised at 1 of 2 sites
  5. Minor Study sites: 3 to 2v11
  6. Minor Site contacts updated at 2 of 3 sitesv10
  7. Minor Re-verified, no change to tracked fieldsv9
  8. Minor Study sites: 4 to 3v8
  9. Minor Site details revised at 1 of 4 sitesv7
  10. Minor Re-verified, no change to tracked fieldsv6
  11. Minor Study sites: 3 to 4v5
  12. Minor Study sites: 2 to 3v4
  13. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 2v3 Show 1 more changeShow less
    • Study sites: 1 to 2
  14. Minor Study title expanded, about 6 wordsv2 See this version in full on ClinicalTrials.gov ↗
  1. Minor 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 prospective, multi-center, non-randomized, non-controlled study designed to obtain survival and outcome data on the Continuum Metal on Polyethylene Acetabular System when used in primary total hip arthroplasty.
Trial Details
NCT Number NCT01307384
Lead Sponsor Zimmer Biomet
Conditions Avascular Necrosis, Osteoarthritis, Inflammatory Arthritis, Post-traumatic Arthritis, Rheumatoid Arthritis
Enrollment 195 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov