Imageless Navigation Versus Image-Based Navigation in Robotic-Assisted Total Knee Arthroplasty for Knee Osteoarthritis
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Contact the study team: see the registry record → Contacts and Locations
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- Who runs it
- Medical University of Warsaw
- Trial code
- NCT07522489
- Record updated
- 13 August 2026
- Original description
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.Read full original descriptionShow less
Outcomes of Robotic-Assisted Total Knee Arthroplasty With Imageless Navigation Versus Image-Based Navigation: A Randomised, Single-Blinded, Non-Inferiority Trial
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.
Inclusion: Symptomatic, radiologically confirmed advanced osteoarthritis of the knee; Patients referred for primary robotic-assisted total knee arthroplasty; Patients in whom a correctly performed radiograph with designated sensors has confirmed the possibility of performing robotic-assisted total knee arthroplasty with image-based navigation; Patients capable of giving informed consent to participate in the study and willing to attend all follow-up visits.
Exclusion: No informed consent for the surgery; Active infections; Diagnosed comorbidities: autoimmune arthritis, malignant tumors, serious neurological disorders affecting a reliable functional outcome measurement (e.g., severe stroke, severe Parkinson's disease); No informed consent for taking part in the study; Pregnancy.