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Navio Robotic Versus Conventional Total Knee Arthroplasty

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

Record History

  1. Enrollment closed, study ongoing Final enrollment: 99 participants (planned 86) · Eligibility criteria expanded, about 12 words · Secondary endpoints: details revised at 3 of 3 entries · 2 more Show 5 more changesShow less
    • Final enrollment: 99 participants (planned 86)
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Site details revised
    • Collaborators: details revised at 1 of 1 entry
  2. Primary and study completion dates: Dec 2025 to Dec 2026v8
  3. Re-verified, no change to tracked fieldsv7
  4. Primary completion date: Dec 2022 to Dec 2025 Completion date: Dec 2023 to Dec 2025v6 Show 1 more changeShow less
    • Completion date: Dec 2023 to Dec 2025
  5. Primary completion date: Aug 1, 2022 to Dec 2022 Completion date: Dec 31, 2022 to Dec 2023v5 Show 1 more changeShow less
    • Completion date: Dec 31, 2022 to Dec 2023
Show 3 earlier versionsHide 3 earlier versions
  1. Re-verified, no change to tracked fieldsv4
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jul 2019 to Apr 17, 2019 · Site details revisedv3 Show 2 more changesShow less
    • Start date changed from estimate of Jul 2019 to Apr 17, 2019
    • Site details revised
  3. Start date: Jul 2018 to Jul 2019 Site contact updatedv2 Show 1 more changeShow less
    • Site contact updated
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Total knee replacement surgery is a conventional approach to alleviating the pain and lack of function resulting from arthritis of the knee. While conventional knee replacement surgery is highly successful, incidences of improperly installed replacement parts are not uncommon. To improve outcomes, robotic-assisted total knee replacement surgery has recently become available, and has been shown to be extremely effective for partial knee replacement surgery. However, further research is needed to determine if this same technology can be equally effective for total knee replacement surgery. The present study will evaluate outcomes of robotic-assisted versus conventional total knee replacement surgery in patients between 40 and 85 years old with end stage arthritis of the knee. Other than surgical technique, patients will receive the same operative care and knee replacement implants. In addition to standard x-rays, subjects will be asked to complete several short-term clinical and functional tests and questionnaires to determine outcomes of their surgery.
Trial Details
NCT Number NCT03519269
Lead Sponsor Columbia University
Collaborators: Smith & Nephew, Inc.
Conditions Osteoarthritis, Knee
Enrollment 99 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov