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Post-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder Arthroplasty

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

Record History

  1. Re-verified, no change to tracked fieldsv11
  2. Enrollment target: 102 to 99v10
  3. 3 versions Re-verified since Nov 2, 2023, no change to tracked fieldsv7-v9
  4. Phase: Not specified to Not applicablev6
  5. Re-verified, no change to tracked fieldsv5
Show 3 earlier versionsHide 3 earlier versions
  1. Secondary endpoints: details revised at 1 of 3 entriesv4
  2. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 146 to confirmed 102 · Study sites: 2 to 6v3 Show 2 more changesShow less
    • Enrollment target: estimated 146 to confirmed 102
    • Study sites: 2 to 6
  3. Enrollment target: 50 to 146 Interventions: Comprehensive Reverse Porous Augmented Glenoid (Device) to Comprehensive Mini Humeral Tray (Device), Comprehensive Reverse Porous Augmented Glenoid (Device) · Study arms: 1 to 2 · Study description expanded, about 5 words · 1 morev2 Show 4 more changesShow less
    • Interventions: Comprehensive Reverse Porous Augmented Glenoid (Device) to Comprehensive Mini Humeral Tray (Device), Comprehensive Reverse Porous Augmented Glenoid (Device)
    • Study arms: 1 to 2
    • Study description expanded, about 5 words
    • Study title expanded, about 2 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study is a multicenter, prospective, non-randomized, non-controlled, dual cohort post market surveillance study. The primary objective of this study is to confirm the safety and performance of the Comprehensive Reverse Shoulder System when used with the Comprehensive Porous Augmented Glenoid Baseplate and/or Comprehensive Mini Humeral Tray in primary and revision reverse shoulder arthroplasty.
Trial Details
NCT Number NCT03726554
Lead Sponsor Zimmer Biomet
Conditions Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff, Osteoarthritis of the Shoulder, Rheumatoid Arthritis Without Humeral Metaphyseal Defects, Post-Traumatic Arthritis
Enrollment 99 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov