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Clinical Outcomes Study of the Nexel Total Elbow

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv16
  2. Site contacts updated at 1 of 11 sitesv15
  3. Primary completion date: Dec 2027 to Dec 2035 Completion date: Dec 2035 to Dec 2036 · Site contacts updated at 2 of 11 sitesv14 Show 2 more changesShow less
    • Completion date: Dec 2035 to Dec 2036
    • Site contacts updated at 2 of 11 sites
  4. Primary completion date: Dec 2024 to Dec 2027 Enrollment target: 120 to 134 · Completion date: Dec 2032 to Dec 2035 · Site contacts updated at 2 of 11 sitesv13 Show 3 more changesShow less
    • Enrollment target: 120 to 134
    • Completion date: Dec 2032 to Dec 2035
    • Site contacts updated at 2 of 11 sites
  5. Re-verified, no change to tracked fieldsv12
Show 10 earlier versionsHide 10 earlier versions
  1. Primary completion date: Dec 2027 to Dec 2024 Completion date: Dec 2028 to Dec 2032 · Site details revised at 5 of 11 sitesv11 Show 2 more changesShow less
    • Completion date: Dec 2028 to Dec 2032
    • Site details revised at 5 of 11 sites
  2. Study sites revised (11)v10 See this version in full on ClinicalTrials.gov ↗
  3. Site details revised at 1 of 11 sitesv9
  4. Study sites: 10 to 11v8
  5. Study sites: 9 to 10v7
  6. Study sites revised (9)v6 See this version in full on ClinicalTrials.gov ↗
  7. Study sites: 3 to 9v5
  8. Re-verified, no change to tracked fieldsv4
  9. Study sites: 2 to 3v3
  10. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The objectives of the study are to confirm safety and performance of the Zimmer Nexel Total Elbow when used in primary or revision total elbow replacement.
Trial Details
NCT Number NCT02469662
Lead Sponsor Zimmer Biomet
Conditions Elbow Joint Destruction, Post-traumatic Lesions, Ankylosed Joints, Advanced Rheumatoid Arthritis, Joint Instability or Loss of Motion, Acute Comminuted Articular Fracture of Elbow Joint Surfaces, Bone Loss Contributing to Elbow Instability, Bilateral Ankylosis From Causes Other Than Active Sepsis +2 more
Enrollment 134 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov