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Post Market Clinical Follow Up of LEGION™ Primary TKS With VERILAST™

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

Record History

  1. 6 versions Re-verified since Dec 7, 2021, no change to tracked fieldsv20-v25
  2. Primary and study completion dates: Mar 2029 to May 2029v19
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 158 to confirmed 163
    • Study sites: 10 to 7
    v18
  4. Study sites: 8 to 10v17
  5. Site details revised at 1 of 8 sitesv16
Show 14 earlier versionsHide 14 earlier versions
  1. Site contacts updated at 1 of 8 sitesv15
  2. Site details revised at 2 of 8 sitesv14
  3. Re-verified, no change to tracked fieldsv13
  4. Site details revised at 2 of 8 sitesv12
  5. Study sites: 7 to 8v11
  6. Site details revised at 3 of 7 sitesv10
  7. Primary and study completion dates: Sep 2027 to Mar 2029
    • Study sites: 4 to 7
    v9
  8. Re-verified, no change to tracked fieldsv8
  9. Site details revised at 1 of 4 sitesv7
  10. Site details revised at 1 of 4 sitesv6
  11. Primary and study completion dates: Jun 2026 to Sep 2027
    • Site details revised at 1 of 4 sites
    v5
  12. Study sites: 2 to 4v4
  13. Study sites: 1 to 2v3
  14. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Mar 2015 to Sep 2015
    • Study sites: 0 to 1
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
LEGION™ Primary Total Knee System is CE-marked and marketed in all study regions. This study serves as post-market surveillance for LEGION™ Primary Total Knee System with the VERILAST™ bearing surface (OXINIUM™ femoral component with highly cross-linked polyethylene tibial insert). All study subjects will receive a LEGION™ Primary Total Knee System with VERILAST™ bearing surface and the results will be analysed against historical data from patients who received a Genesis II knee replacement.
Trial Details
NCT Number NCT02380092
Lead Sponsor Smith & Nephew, Inc.
Conditions
(from sponsor)		 Degenerative Joint Disease
Related terms Joint Diseases
Enrollment 163 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov