Not Yet RecruitingNot Applicable

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

Poland146 participantsStarted 2026-05

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 criteria

. No informed consent for the surgery.
. No informed consent for taking part in the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patient-Reported Outcome Measures assessed with the Oxford Knee Score

Timeframe: Survey taken right before surgery, at 6 months, and at 12 months after surgery.

Trial details

NCT IDNCT07522489

SponsorMedical University of Warsaw

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-01

Contact for this trial

Paweł Kasprzak, MD

22 50 21 514 pawel.kasprzak@wum.edu.pl

View on ClinicalTrials.gov More Osteoarthritis (OA) of the Knee trials