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

NCT07522489 | Not Yet Recruiting

• 1 other identifier: KB/178/2025
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does imageless procedure provide functional results comparable to those of image-based navigation?
2. 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.
3. 3.Answer survey questions about knee pain and function before RA-TKA.
4. 4.Undergo RA-TKA with imageless navigation or image-based navigation.
5. 5.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

Keywords

Knee Osteoarthritis; Robotic-Assisted Total Knee Arthroplasty; Patient Reported Outcome Measures; Imageless Navigation; Image-based Navigation

Outcome Measures

Primary Outcomes (1)

• 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.

  Survey taken right before surgery, at 6 months, and at 12 months after surgery.

Secondary Outcomes (9)

• Number of Participants achieving a planned postoperative limb alignment

  From enrollment to 12 months after surgery.

• Postoperative radiographic results

  From enrollment to 12 months after surgery.

• Postoperative pain assessed with a VAS scale

  Survey taken right before surgery, at 6 months, and at 12 months after surgery.

• Time of the surgical procedure

  From the beginning to the end of the surgical procedure.

• Estimation of perioperative blood loss

  Immediately after the end of the surgery.

Study Arms (2)

Imageless Robotic Navigation

ACTIVE COMPARATOR

Procedure: Imageless Robotic-Assisted Total Knee Arthroplasty

Image-based Robotic Navigation

ACTIVE COMPARATOR

Procedure: Image-based Robotic-Assisted Total Knee Arthroplasty

Interventions

Imageless Robotic-Assisted Total Knee Arthroplasty PROCEDURE

Patients undergoing Robotic-Assisted Total Knee Arthroplasty with Imageless Navigation

Imageless Robotic Navigation

Image-based Robotic-Assisted Total Knee Arthroplasty PROCEDURE

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

Image-based Robotic Navigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• No informed consent for the surgery.
• No informed consent for taking part in the study.
• Pregnancy.
• Active infections.
• Diagnosed comorbidities: autoimmune arthritis, malignant tumors, serious neurological disorders affecting a reliable functional outcome measurement (e.g., severe stroke, severe Parkinson's disease).

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Orthopedics and Locomotor Traumatology, Medical University of Warsaw

Warsaw, Mazovian, 02-005, Poland

Location

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Paweł Łęgosz, MD, Professor

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

• Łukasz Pulik, MD, PhD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

• Paweł Kasprzak, MD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paweł Kasprzak, MD

CONTACT

22 50 21 514; pawel.kasprzak@wum.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Within 12 months of the trial completion.
• Access Criteria: Data and supporting information will be shared upon reasonable request to the Principal Investigator. After the Principal Investigator reviews and approves the applicant's request, de-identified information will be provided.

Locations

PL (1)