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Zimmer Biomet Shoulder Arthroplasty PMCF Study

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment target: 40 to 50 Primary completion date: Dec 31, 2028 to Jun 2029 · Completion date: Dec 31, 2036 to Jun 2037 · Site details revised at 1 of 2 sitesv5 Show 3 more changesShow less
    • Primary completion date: Dec 31, 2028 to Jun 2029
    • Completion date: Dec 31, 2036 to Jun 2037
    • Site details revised at 1 of 2 sites
  2. Primary completion date: Jul 31, 2028 to Dec 31, 2028 Completion date: Jul 31, 2036 to Dec 31, 2036 · Site details revised at 2 of 2 sitesv4 Show 2 more changesShow less
    • Completion date: Jul 31, 2036 to Dec 31, 2036
    • Site details revised at 2 of 2 sites
  3. Study sites: 1 to 2 Start date changed from estimate of May 1, 2025 to Apr 29, 2025v3 Show 1 more changeShow less
    • Start date changed from estimate of May 1, 2025 to Apr 29, 2025
  4. Trial status: Not Yet Recruiting to Recruiting Site details revisedv2 Show 1 more changeShow less
    • Site details revised
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
This is a multicenter, prospective, non-controlled post market surveillance study. The objectives of this study are to confirm the safety, performance, and clinical benefits of the Zimmer Biomet Shoulder Arthroplasty systems in primary anatomic shoulder arthroplasty and its instrumentation. Safety of the systems will be assessed by monitoring the frequency and incidence of adverse events. The performance and clinical benefits will be evaluated by assessment of the overall pain and functional performance, qualify of life, and radiographic parameters of all enrolled study subjects.
Trial Details
NCT Number NCT06920459
Lead Sponsor Zimmer Biomet
Conditions Shoulder Fractures, Shoulder Arthritis Osteoarthritis, Shoulder Injury, Shoulder Pain, Degenerative Joint Disease, Arthritis Shoulder
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov