Imageless vs. image-based navigation in robot-assisted knee replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial compares imageless navigation to image-based navigation during robotic-assisted total knee arthroplasty for end-stage knee osteoarthritis. Participants are assigned 1:1 to either method and followed for 12 months, with functional surveys and postoperative checkups. All procedures are performed by experienced surgeons using a standardized surgical protocol. The primary focus is on functional outcomes and postoperative complications, with remote monitoring and radiographic assessments as part of the evaluation.

Why it matters

Who can join: the full rules

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).

Where it's running

• Department of Orthopedics and Locomotor Traumatology, Medical University of Warsaw
  Warsaw, Mazovian, Poland Recruiting

Study contacts

• Principal investigator: Paweł Łęgosz, MD, Professor — Medical University of Warsaw
• Study coordinator: Paweł Kasprzak, MD
• Email: pawel.kasprzak@wum.edu.pl
• Phone: 22 50 21 514

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.