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

RecruitingNAAges 18 Years - anyAllMedical University of Warsaw
NCT07522489 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 a

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Symptomatic, radiologically confirmed advanced osteoarthritis of the knee. 2. Patients referred for primary robotic-assisted total knee arthroplasty. 3. 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. 4. Patients capable of giving informed consent to participate in the study and willing to attend all follow-up visits. Exclusion Criteria: 1. No informed consent for the surgery. 2. No informed consent for taking part in the study. 3. Pregnancy. 4. Active infections. 5. Diagnosed comorbidities: autoimmune arthritis, malignant tumors, serious neurological disorders affecting a reliable functional outcome measurement (e.g., severe stroke, severe Parkinson's disease).
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What it tests

  • Imageless Robotic-Assisted Total Knee Arthroplasty
  • Image-based Robotic-Assisted Total Knee Arthroplasty
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Where

1 site
Department of Orthopedics and Locomotor Traumatology, Medical University of Warsaw
Warsaw, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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