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Comparative Study of Navigation-assisted OrthoPilot® Elite and Robotic-assisted MAKO® Total Knee Arthroplasty

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

Record History

  1. Re-verified, no change to tracked fieldsv8
  2. Primary completion date: Jan 2026 to Dec 2027 Completion date: Dec 2026 to Dec 2028v7 Show 1 more changeShow less
    • Completion date: Dec 2026 to Dec 2028
  3. Primary completion date: Dec 2025 to Jan 2026v6
  4. Re-verified, no change to tracked fieldsv5
  5. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jun 2024 to Jul 3, 2024 · Site details revisedv4 Show 2 more changesShow less
    • Start date changed from estimate of Jun 2024 to Jul 3, 2024
    • Site details revised
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Dec 2023 to Jun 2024 Primary completion date: Jun 2025 to Dec 2025 · Completion date: Jun 2026 to Dec 2026v3 Show 2 more changesShow less
    • Primary completion date: Jun 2025 to Dec 2025
    • Completion date: Jun 2026 to Dec 2026
  2. Study title shortened, about 5 wordsv2 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Randomized, controlled, single center observational study to compare the safety and performance of navigation-assisted OrthoPilot Elite and robotic-assisted MAKO total knee arthroplasty (TKA). The aim of the study is the comparison of the clinical outcome between navigated and robotic-assisted TKA. The hypothesis of the study is that both treatments achieve similar results regarding functional and clinical aspects.
Trial Details
NCT Number NCT05980442
Lead Sponsor Aesculap AG
Conditions Osteoarthritis, Knee, Joint Diseases, Rheumatoid Arthritis of Knee, Posttraumatic Arthropathy
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov