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A Prospective Randomized Controlled Trial of Dual-Mobility Components in Primary THA

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Notable Primary completion date: Dec 1, 2025 to Dec 1, 2035
    • Study completion date: Dec 1, 2026 to Dec 1, 2036
    v11
  2. Minor Re-verified, no change to tracked fieldsv10
  3. Notable Primary completion date: Sep 1, 2024 to Dec 1, 2025v9
  4. Minor Primary completion date: May 1, 2024 to Sep 1, 2024v8
  5. Notable Primary completion date: May 24, 2023 to May 1, 2024v7
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  1. Notable Primary completion date: May 24, 2021 to May 24, 2023v6
  2. Minor Primary completion date changed from estimate of Dec 1, 2021 to May 24, 2021
    • Study completion date: Dec 1, 2024 to Dec 1, 2026
    v5
  3. Notable Primary completion date: Dec 1, 2019 to Dec 1, 2021
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v4
  4. Notable Primary completion date: Jan 1, 2019 to Dec 1, 2019
    • Study completion date: Jan 1, 2024 to Dec 1, 2024
    v3
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study description shortened, about 9 words
    • Site details revised
    • Study title shortened, about 9 words
    v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 aim of this study is to determine if the use of a modular dual mobility bearing is associated with clinically important increases in serum metal levels.
Trial Details
NCT Number NCT03371212
Lead Sponsor Rush University Medical Center
Collaborators: Zimmer Biomet
Conditions
(from sponsor)
Serum Metal Levels, Specifically Cobalt, Chromium, and Titanium
Enrollment 52 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov