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Outcomes of Robotic-Assisted Total Knee Arthroplasty With Imageless Navigation Versus Image-Based Navigation: A Randomised, Single-Blinded, Non-Inferiority Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Poland
Department of Orthopedics and Locomotor Traumatology, Medical University of Warsaw
RECRUITING
Warsaw
Contact Information
Primary
Paweł Kasprzak, MD
pawel.kasprzak@wum.edu.pl
22 50 21 514
Time Frame
Start Date: 2026-08-06
Estimated Completion Date: 2029-01
Participants
Target number of participants: 146
Treatments
Active_comparator: Imageless Robotic Navigation
Active_comparator: Image-based Robotic Navigation
Sponsors
Leads: Medical University of Warsaw

This content was sourced from clinicaltrials.gov