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.
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.
No informed consent for the surgery.
No informed consent for taking part in the study.
Pregnancy.
Active infections.
Parallel
Imageless Robotic-Assisted Total Knee Arthroplasty
Procedure/SurgeryPatients undergoing Robotic-Assisted Total Knee Arthroplasty with Imageless Navigation
Image-based Robotic-Assisted Total Knee Arthroplasty
Procedure/SurgeryPatients undergoing Robotic-Assisted Total Knee Arthroplasty with Image-based Navigation
Patient-Reported Outcome Measures assessed with the Oxford Knee Score
Zero is equivalent to the worst possible function of the joint and 48 indicates the best achievable function.
Range of motion
Measured according to the neutral-zero method with a 360-degree goniometer.
Number of Participants achieving a planned postoperative limb alignment
The percentage of patients within ±3 degrees of the preoperative target.
Postoperative radiographic results
Hip-Knee-Ankle angle, mechanical axis deviation, coronal femoral component angle (mechanical lateral distal femoral angle, mechanical lateral proximal femoral angle), sagittal femoral tilt/flexion, coronal tibial component angle (mechanical/anatomical lateral distal tibial angle, mechanical/anatomical medial proximal tibial angle) posterior tibial slope, joint line convergence angle, all measured in degrees
Postoperative pain assessed with a VAS scale
Zero is equivalent to no pain and 10 indicates the worst possible pain.
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