Clinical Trial

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

Recruiting
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Summary
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.
Protocol Amendment History 1 change
critical Recruitment opened 2026-08-14
Trial Details
NCT Number NCT07522489
Lead Sponsor Medical University of Warsaw
Conditions Osteoarthritis (OA) of the Knee, Knee Pain Arthritis, Total Knee Arthroplasty (TKA), Robotic Assisted Arthroplasty
Enrollment 146 participants
Start Date 2026-08-06
Primary Completion 2029-01 (estimated)
Study Completion 2029-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-13