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Study to Evaluate the Performance of Navigated TKA With OrthoPilot® pheno4u TKA Level 1

Study acronym: TKA4U
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Sep 2026 to Jul 2027 · Study sites: 0 to 4 · Start date changed from estimate of Sep 2025 to Oct 7, 2025v5 Show 3 more changesShow less
    • Primary completion date: Sep 2026 to Jul 2027
    • Study sites: 0 to 4
    • Start date changed from estimate of Sep 2025 to Oct 7, 2025
  2. Re-verified, no change to tracked fieldsv4
  3. Start date: Jun 2025 to Sep 2025 Primary completion date: Jun 2026 to Sep 2026v3 Show 1 more changeShow less
    • Primary completion date: Jun 2026 to Sep 2026
  4. Secondary endpoints: details revised at 1 of 8 entriesv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this PMCF study is to demonstrate the accuracy of navigation using the new pheno4uTKA Level 1 software for OrthoPilot Elite® and to evaluate its safety and performance. Patient-related outcome measures (PROM) will be acquired to investigate functional outcome and patient satisfaction.
Trial Details
NCT Number NCT06955481
Lead Sponsor Aesculap AG
Collaborators: Raylytic GmbH
Conditions Osteoarthritis, Knee, Joint Diseases, Rheumatoid Arthritis of Knee, Posttraumatic Arthropathy
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov