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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Warsaw

About this trial

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

Qualifiers

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.

Disqualifiers

No informed consent for the surgery.

No informed consent for taking part in the study.

Pregnancy.

Active infections.

Trial design

Treatments tested in this trial

  • Imageless Robotic-Assisted Total Knee Arthroplasty
  • Image-based Robotic-Assisted Total Knee Arthroplasty

Treatment groups

146 Participants
are divided into 2 treatment groups

Sponsors and collaborators