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Clinical Results and RSA Migration Analysis of the GLOBAL ICON - Stemless Anatomic Shoulder

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Dec 31, 2027 to Jan 25, 2024v8
  2. Primary completion date: Jan 17, 2024 to Dec 31, 2027
    • Study completion date: Mar 17, 2024 to Dec 31, 2027
    v7
  3. Primary completion date: Sep 17, 2023 to Jan 17, 2024v6
  4. Trial status: Not Yet Recruiting to Recruitingv5 Show 4 more changesShow less
    • Primary completion date: Oct 1, 2023 to Sep 17, 2023
    • Study completion date: Apr 30, 2024 to Mar 17, 2024
    • Start date changed from estimate of Oct 1, 2021 to Sep 17, 2021
    • Site details revised
  5. Start date: Aug 1, 2021 to Oct 1, 2021
    • Primary completion date: Aug 1, 2023 to Oct 1, 2023
    • Study completion date: Feb 29, 2024 to Apr 30, 2024
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Apr 30, 2021 to Aug 1, 2021
    • Primary completion date: Apr 30, 2023 to Aug 1, 2023
    • Study completion date: Oct 31, 2023 to Feb 29, 2024
    v3
  2. Primary completion date: Aug 31, 2022 to Apr 30, 2023
    • Start date: Aug 31, 2020 to Apr 30, 2021
    • Study completion date: Feb 29, 2024 to Oct 31, 2023
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 primary goal of the clinical trial is to determine that the GLOBAL ICON implant system from DePuy does not exhibit worse shoulder function after 2 years than the SIMPLICITY from Wright Medical. The primary endpoint is the Constant-Murley Shoulder Score (CMSS) of the implant after 2 years, the non-inferiority of which is to be demonstrated in comparison with an already established prosthetic system (SIMPLICITY, Wright Medical).
Trial Details
NCT Number NCT04468178
Lead Sponsor Hannover Medical School
Conditions
(from sponsor)		 Osteoarthritis of the Shoulder
Related terms Osteoarthritis
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov