Imageless Navigation Versus Image-Based Navigation in Robotic-Assisted Total Knee Arthroplasty for Knee Osteoarthritis
Recruiting · NCT07522489 · Interventional (participants receive a specific treatment) · Lead sponsor: Medical University of Warsaw
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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.
- Pregnancy.
- Active infections.
- 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 is running
1 location listed.
- Department of Orthopedics and Locomotor Traumatology, Medical University of Warsaw - Warsaw, Mazovian, Poland