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NCT07522489
Imageless Navigation Versus Image-Based Navigation in Robotic-Assisted Total Knee Arthroplasty for Knee Osteoarthritis
Conditions: Osteoarthritis (OA) of the Knee, Knee Pain Arthritis, Total Knee Arthroplasty (TKA), Robotic Assisted Arthroplasty
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 146
Sponsor: Medical University of Warsaw
Location: Department of Orthopedics and Locomotor Traumatology, Medical University of Warsaw Warsaw Mazovian
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).
Source: ClinicalTrials.gov (NCT07522489). StuddyBuddy aggregates publicly available trial information.