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GMK-UNI Anatomical UKA: Fixation of Cemented vs Cementless Designs

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

Record History

  1. Study Identification, Study Statusv7
  2. Primary completion date: Dec 1, 2024 to Dec 1, 2026 Site details revised at 5 of 5 sitesv6 Show 1 more changeShow less
    • Site details revised at 5 of 5 sites
  3. Primary completion date: Dec 1, 2023 to Dec 1, 2024v5
  4. Primary completion date: Jun 2021 to Dec 1, 2023 Start date: Mar 14, 2018 to Feb 15, 2019 · Trial status: Recruiting to Active, Not Recruiting · Completion date: Jun 2026 to Dec 1, 2026 · 1 morev4 Show 4 more changesShow less
    • Start date: Mar 14, 2018 to Feb 15, 2019
    • Trial status: Recruiting to Active, Not Recruiting
    • Completion date: Jun 2026 to Dec 1, 2026
    • Site details revised at 5 of 5 sites
  5. Primary completion date: Jun 2020 to Jun 2021 Completion date: Jun 2025 to Jun 2026 · Site details revised at 1 of 5 sitesv3 Show 2 more changesShow less
    • Completion date: Jun 2025 to Jun 2026
    • Site details revised at 1 of 5 sites
  6. Secondary endpoints revised (6)v2 See this version in full on ClinicalTrials.gov ↗
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Unicompartmental knee arthroplasty (UKA) is the principal surgical alternative to the total knee arthroplasty (TKA) in patients with end-stage unicompartmental tibiofemoral osteoarthritis (OA) of the knee. The current comparative randomized study aims to evaluate the fixation of cemented and cementless designs of GMK-UNI unicompartmental knee prosthesis over a 5-year time period.
Trial Details
NCT Number NCT03522025
Lead Sponsor Medacta International SA
Conditions Osteoarthritis, Knee
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov