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Cemented vs Cementless Persona Keel RCT

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

Record History

  1. Study sites: 8 to 7v12
  2. Trial status: Recruiting to Active, Not Recruiting Site details revised at 8 of 8 sitesv11 Show 1 more changeShow less
    • Site details revised at 8 of 8 sites
  3. Site contacts updated at 1 of 8 sitesv10
  4. Study sites revised (8)v9 See this version in full on ClinicalTrials.gov ↗
  5. Study sites: 7 to 8v8
Show 6 earlier versionsHide 6 earlier versions
  1. Site details revised at 1 of 7 sitesv7
  2. Study sites: 5 to 7v6
  3. Site details revised at 3 of 5 sitesv5
  4. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 5 · Start date changed from estimate of May 2023 to Jul 25, 2023v4 Show 2 more changesShow less
    • Study sites: 0 to 5
    • Start date changed from estimate of May 2023 to Jul 25, 2023
  5. Start date: Mar 2023 to May 2023 Primary completion date: Mar 2032 to May 2032 · Completion date: Mar 2032 to Dec 2032v3 Show 2 more changesShow less
    • Primary completion date: Mar 2032 to May 2032
    • Completion date: Mar 2032 to Dec 2032
  6. Start date: Dec 2022 to Mar 2023 Primary endpoint revised · Enrollment target: 224 to 300 · Interventions: Cemented Persona 0° Knee System (Device), Cementless Persona 0° Knee System (Device) to Cemented Persona Knee System (Device), Cementless Persona Knee System (Device) · 4 morev2 Show 7 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 224 to 300
    • Interventions: Cemented Persona 0° Knee System (Device), Cementless Persona 0° Knee System (Device) to Cemented Persona Knee System (Device), Cementless Persona Knee System (Device)
    • Secondary endpoints revised (6)
    • Study title revised
    • Eligibility criteria shortened, about 1 word
    • Study description shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 main objective of this study is to evaluate the safety, performance, and clinical benefits of the Persona Keel cementless and cemented knee.
Trial Details
NCT Number NCT05630053
Lead Sponsor Zimmer Biomet
Conditions Knee Pain Chronic, Rheumatoid Arthritis, Osteoarthritis, Traumatic Arthritis, Polyarthritis, Avascular Necrosis, Varus Deformity, Valgus Deformity +1 more
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov