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Zimmer Trabecular Metal Total Ankle PMCF

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

Record History

  1. Minor Primary completion date: Mar 2027 to Sep 2027 Completion date: Mar 2027 to Dec 2027v25 Show 1 more changeShow less
    • Completion date: Mar 2027 to Dec 2027
  2. Minor 8 versions Re-verified since Sep 7, 2021, no change to tracked fieldsv17-v24
  3. Minor Study title expanded, about 1 wordv16 See this version in full on ClinicalTrials.gov ↗
  4. Minor Study sites revised (11)v15 See this version in full on ClinicalTrials.gov ↗
  5. Minor 3 versions Re-verified since Nov 14, 2018, no change to tracked fieldsv12-v14
Show 10 earlier versionsHide 10 earlier versions
  1. Notable Phase: Phase 4 to Not applicablev11
  2. Minor Study sites: 9 to 11v10
  3. Minor Trial status: Recruiting to Active, Not Recruiting Site details revised at 9 of 9 sitesv9 Show 1 more changeShow less
    • Site details revised at 9 of 9 sites
  4. Minor Re-verified, no change to tracked fieldsv8
  5. Minor Site details revised at 1 of 9 sitesv7
  6. Minor Study sites: 8 to 9v6
  7. Minor Study sites: 5 to 8v5
  8. Minor Study sites: 4 to 5v4
  9. Minor Study sites: 3 to 4v3
  10. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3 · Primary and study completion dates: Jan 2027 to Mar 2027 · Start date: Jan 2014 to Mar 2014v2 Show 3 more changesShow less
    • Study sites: 0 to 3
    • Primary and study completion dates: Jan 2027 to Mar 2027
    • Start date: Jan 2014 to Mar 2014
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The primary objective of this study is to obtain implant survivorship and clinical outcome data for commercially available Zimmer Trabecular Metal Total Ankle implants used in primary or revision total ankle arthroplasty. The assessment will include implant survivorship and clinical performance measured by pain and function, quality of life data, radiographic parameters and survivorship.
Trial Details
NCT Number NCT02038140
Lead Sponsor Zimmer Biomet
Conditions Degenerative Arthritis, Rheumatoid Arthritis, Post Traumatic Arthritis
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov