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Post Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System

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

Record History

  1. Primary and study completion dates: Dec 2025 to Dec 2026v14
  2. Site details revised at 4 of 7 sitesv13
  3. Primary and study completion dates: May 2025 to Dec 2025v12
  4. Trial status: Recruiting to Active, Not Recruiting Study sites: 2 to 7v11 Show 1 more changeShow less
    • Study sites: 2 to 7
  5. Primary completion date: May 2024 to May 2025 Completion date: Jul 2024 to May 2025v10 Show 1 more changeShow less
    • Completion date: Jul 2024 to May 2025
Show 8 earlier versionsHide 8 earlier versions
  1. Site details revised at 1 of 2 sitesv9
  2. Primary completion date: Sep 2023 to May 2024 Completion date: Dec 2023 to Jul 2024v8 Show 1 more changeShow less
    • Completion date: Dec 2023 to Jul 2024
  3. Primary completion date: Sep 2022 to Sep 2023 Completion date: Dec 2022 to Dec 2023v7 Show 1 more changeShow less
    • Completion date: Dec 2022 to Dec 2023
  4. Site details revised at 1 of 2 sitesv6
  5. Primary completion date: Jan 2022 to Sep 2022 Completion date: Jan 2022 to Dec 2022v5 Show 1 more changeShow less
    • Completion date: Jan 2022 to Dec 2022
  6. Secondary endpoints: details revised at 1 of 3 entries Study title expanded, about 4 wordsv4 Show 1 more changeShow less
    • Study title expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  7. Primary and study completion dates: Jan 2021 to Jan 2022 Site contacts updated at 1 of 2 sitesv3 Show 1 more changeShow less
    • Site contacts updated at 1 of 2 sites
  8. Study sites: 1 to 2v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 post-market clinical follow-up study. The primary objective of this study is to confirm the safety and performance of the A.L.P.S. Proximal Humerus Plating System applied in proximal humerus fracture treatment.
Trial Details
NCT Number NCT03626038
Lead Sponsor Zimmer Biomet
Conditions Osteoarthritis, Rheumatoid Arthritis, Post-Traumatic Arthritis, Psoriatic Arthritis, Proximal Humeral Fracture
Enrollment 135 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov