Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Not Yet Recruiting 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).

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07522489). StuddyBuddy aggregates publicly available trial information.