NCT07522489 Imageless Navigation Versus Image-Based Navigation in Robotic-Assisted Total Knee Arthroplasty for Knee Osteoarthritis
| NCT ID | NCT07522489 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Warsaw |
| Condition | Osteoarthritis (OA) of the Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 146 participants |
| Start Date | 2026-08-06 |
| Primary Completion | 2029-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 146 participants in total. It began in 2026-08-06 with a primary completion date of 2029-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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).
Contact & Investigator
Paweł Łęgosz, MD, Professor
PRINCIPAL INVESTIGATOR
Medical University of Warsaw
Frequently Asked Questions
Who can join the NCT07522489 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Osteoarthritis (OA) of the Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07522489 currently recruiting?
Yes, NCT07522489 is actively recruiting participants. Contact the research team at pawel.kasprzak@wum.edu.pl for enrollment information.
Where is the NCT07522489 trial being conducted?
This trial is being conducted at Warsaw, Poland.
Who is sponsoring the NCT07522489 clinical trial?
NCT07522489 is sponsored by Medical University of Warsaw. The principal investigator is Paweł Łęgosz, MD, Professor at Medical University of Warsaw. The trial plans to enroll 146 participants.