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Imageless Navigation Versus Image-Based Navigation in Robotic-Assisted Total Knee Arthroplasty for Knee Osteoarthritis

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Recruitment opened
    • Start date changed from estimate of Jul 2026 to Aug 6, 2026
    • Secondary endpoints: details revised at 1 of 10 entries
    • Site details revised
    v3
  2. Start date: May 2026 to Jul 2026
    • Secondary endpoints: 9 to 10
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this clinical trial is to learn if imageless navigation is not inferior to image-based navigation in robotic-assisted total knee arthroplasty (RA-TKA) for treating patients with knee osteoarthritis. The main questions the study aims to answer are: 1. Does imageless procedure provide functional results comparable to those of image-based navigation? 2. Are there differences in postoperative complications patients may experience after RA-TKA with imageless and image-based navigation? Researchers will compare imageless navigation with image-based navigation used in total knee arthroplasty to assess whether imageless navigation is comparable for the treatment of knee osteoarthritis. Participants will: 1. Answer survey questions about knee pain and function before RA-TKA. 2. Undergo RA-TKA with imageless navigation or image-based navigation. 3. Visit the Clinic after 6 months and 12 months after surgery for checkups and to answer the same survey questions about postoperative knee pain and function.
Trial Details
NCT Number NCT07522489
Lead Sponsor Medical University of Warsaw
Conditions
(from sponsor)		 Osteoarthritis (OA) of the Knee, Knee Pain Arthritis, Total Knee Arthroplasty (TKA), Robotic Assisted Arthroplasty
Related terms Osteoarthritis, Osteoarthritis, Knee
Enrollment 146 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov