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

RECRUITINGN/ASponsored by Medical University of Warsaw
Actively Recruiting
PhaseN/A
SponsorMedical University of Warsaw
Started2026-08-06
Est. completion2029-01
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
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).

Conditions5

ArthritisKnee Pain ArthritisOsteoarthritis (OA) of the KneeRobotic Assisted ArthroplastyTotal Knee Arthroplasty (TKA)

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