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

NCT07522489 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

  • Osteoarthritis (OA) of the Knee
  • Knee Pain Arthritis
  • Total Knee Arthroplasty (TKA)
  • Robotic Assisted Arthroplasty

Interventions

PROCEDURE

Imageless Robotic-Assisted Total Knee Arthroplasty

Patients undergoing Robotic-Assisted Total Knee Arthroplasty with Imageless Navigation

PROCEDURE

Image-based Robotic-Assisted Total Knee Arthroplasty

Patients undergoing Robotic-Assisted Total Knee Arthroplasty with Image-based Navigation

Sponsors & Collaborators

  • Medical University of Warsaw

    lead OTHER

Principal Investigators

  • Paweł Łęgosz, MD, Professor · Medical University of Warsaw

  • Łukasz Pulik, MD, PhD · Medical University of Warsaw

  • Paweł Kasprzak, MD · Medical University of Warsaw

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2029-01-31
Completion
2029-01-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07522489 on ClinicalTrials.gov