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Safety and Performance Study of the Legion Porous System in Total Knee Arthroplasty

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. 2 versions Re-verified since Apr 1, 2024, no change to tracked fieldsv14-v15
  2. Primary completion date: Feb 23, 2031 to Jan 23, 2031v13
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 150 to confirmed 118
    • Site details revised at 2 of 2 sites
    v12
  4. Re-verified, no change to tracked fieldsv11
  5. Primary completion date: Jan 1, 2029 to Feb 23, 2031
    • Study completion date: Jan 1, 2030 to Dec 31, 2032
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Primary completion date: Jan 1, 2028 to Jan 1, 2029
    • Study completion date: Jan 1, 2029 to Jan 1, 2030
    • Site contacts updated at 2 of 2 sites
    v9
  2. Re-verified, no change to tracked fieldsv8
  3. Site details revised at 1 of 2 sitesv7
  4. Re-verified, no change to tracked fieldsv6
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Mar 31, 2019 to May 22, 2019
    v5
  6. Start date: Feb 28, 2019 to Mar 31, 2019v4
  7. Start date: Jan 1, 2019 to Feb 28, 2019v3
  8. Secondary endpoints revised (5)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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this research is to collect data on patients that had the Legion Porous HA Tibial Baseplates and/or the Legion Porous HA Femoral component implanted in the past. Smith \& Nephew will evaluate the safety and performance of these implants for 10 years post-surgery.
Trial Details
NCT Number NCT03720782
Lead Sponsor Smith & Nephew, Inc.
Conditions
(from sponsor)		 Total Knee Arthroplasty
Enrollment 118 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov