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Zimmer Biomet Shoulder Arthroplasty PMCF

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 5 of 17 sitesv16
  2. Site details revised at 4 of 17 sitesv15
  3. Re-verified, no change to tracked fieldsv14
  4. Site details revised at 5 of 17 sitesv13
  5. Site details revised at 1 of 17 sitesv12
Show 10 earlier versionsHide 10 earlier versions
  1. Site details revised at 4 of 17 sitesv11
  2. Study sites: 12 to 17v10
  3. Study sites: 9 to 12v9
  4. Study sites: 8 to 9v8
  5. Enrollment target: 365 to 584 Study sites: 7 to 8 · Interventions: Alliance Glenoid (Device) to Alliance Glenoid (Device), Identity Stem (Device) · Eligibility criteria expanded, about 72 wordsv7 Show 3 more changesShow less
    • Study sites: 7 to 8
    • Interventions: Alliance Glenoid (Device) to Alliance Glenoid (Device), Identity Stem (Device)
    • Eligibility criteria expanded, about 72 words

    See this version in full on ClinicalTrials.gov ↗

  6. Site details revised at 4 of 7 sitesv6
  7. Site contacts updated at 1 of 7 sitesv5
  8. Study sites: 6 to 7v4
  9. Study sites: 2 to 6v3
  10. Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 2 · Start date changed from estimate of Aug 15, 2021 to Jul 28, 2021v2 Show 2 more changesShow less
    • Study sites: 1 to 2
    • Start date changed from estimate of Aug 15, 2021 to Jul 28, 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Zimmer Biomet
83 trials monitored
See 1 trial at risk
The objectives of this study are to confirm the safety, performance, and clinical benefits of Zimmer Biomet Shoulder Arthroplasty Systems and its instrumentation in primary or revision shoulder arthroplasty. These objectives will be assessed using standard scoring systems, radiographic evidence, and adverse event records. Safety of the system will be assessed by monitoring the frequency an incidence of adverse events.
Trial Details
NCT Number NCT04984291
Lead Sponsor Zimmer Biomet
Conditions Shoulder Fractures, Shoulder Arthritis, Shoulder Osteoarthritis, Shoulder Deformity, Shoulder Injuries, Shoulder Pain
Enrollment 584 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov