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Safety and Performance Using Legion™ CR Oxinium and CoCr Femoral Implants Combined With Legion™/Genesis™ II XLPE High Flex Tibial Inserts

Study acronym: Legion Oxinium
StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. 15 versions Re-verified since Nov 8, 2022, no change to tracked fieldsv14-v28
  2. Primary completion date: Jun 1, 2029 to Oct 1, 2027
    • Study completion date: Jan 1, 2030 to Apr 1, 2028
    • Start date: Sep 30, 2018 to Aug 26, 2018
    v13
  3. 4 versions Re-verified since Feb 25, 2021, no change to tracked fieldsv9-v12
  4. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 118 to confirmed 126
    • Site details revised at 4 of 4 sites
    v8
  5. Study sites: 3 to 4v7
Show 5 earlier versionsHide 5 earlier versions
  1. Re-verified, no change to tracked fieldsv6
  2. Study sites: 2 to 3v5
  3. Re-verified, no change to tracked fieldsv4
  4. Study sites: 1 to 2
    • Eligibility criteria expanded, about 77 words
    v3
  5. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this research is to collect data on patients that had the Legion CR Oxinium and CoCr Femoral Implant and the Legion/Genesis II XLPE High Flex Tibial Inserts implanted in the past. Smith \& Nephew will evaluate the safety and performance of these implants.
Trial Details
NCT Number NCT03687593
Lead Sponsor Smith & Nephew, Inc.
Conditions
(from sponsor)		 Total Knee Arthroplasty
Enrollment 126 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov