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LEGION Hinge Safety and Efficacy Study

Study acronym: LINKS
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 10 to 7v16
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 55 to confirmed 47
    • Site details revised at 10 of 10 sites
    v15
  3. Re-verified, no change to tracked fieldsv14
  4. Site contacts updated at 2 of 10 sitesv13
  5. Primary completion date: Dec 31, 2024 to Dec 31, 2027
    • Enrollment target: 45 to 55
    • Study sites: 9 to 10
    • Study completion date: Mar 1, 2025 to Aug 1, 2028
    v12
Show 10 earlier versionsHide 10 earlier versions
  1. 2 versions Re-verified since Mar 8, 2021, no change to tracked fieldsv10-v11
  2. Primary completion date: May 2019 to Dec 31, 2024
    • Study completion date: Sep 2023 to Mar 1, 2025
    • Start date: Jun 2015 to Jun 30, 2015
    • Site contacts updated at 5 of 9 sites
    v9
  3. Study sites: 8 to 9v8
  4. Primary completion date: May 2018 to May 2019v7
  5. Site details revised at 1 of 8 sitesv6
  6. Study sites: 6 to 8v5
  7. Study sites: 4 to 6
    • Primary completion date: Aug 2018 to May 2018
    • Study completion date: Aug 2021 to Sep 2023
    • Start date: Aug 2015 to Jun 2015
    v4
  8. Study sites: 2 to 4v3
  9. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date: Jun 2015 to Aug 2015
    • Study sites: 0 to 2
    • Primary completion date: Jun 2018 to Aug 2018
    • Study completion date: Jun 2021 to Aug 2021
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 the current investigation is to assess the safety and efficacy of a new hinged revision knee device. This device is designed to provide efficient, reproducible reconstructions with optimal limb and implant alignment, durable implant fixation, and functional outcomes that increasingly approach those of primary Total Knee Arthroplasty (TKA).
Trial Details
NCT Number NCT02445443
Lead Sponsor Smith & Nephew, Inc.
Conditions
(from sponsor)		 Knee Arthroplasty, Total
Enrollment 47 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov