Comparison of Image Based Robotic Total Knee Arthroplasty Vs Imageless Augmented Reality Assisted Total Knee Arthroplasty (RobAR)

RobAR Study: Comparison of Image Based Robotic TKA Vs Imageless Augmented Reality-Assisted TKA

This study compares the accuracy of two different techniques in placing a total knee replacement. In one technique, accurate instrument placement is facilitated by a robot, and in the other technique, augmented reality is used for correct instrument placement. Both surgical techniques are already commonly used. During both the robotic technique and the augmented reality technique, the additional information (angles - axes) obtained during the operation is used to optimize the placement of the various prosthesis components.

Patients that were recently diagnosed with advanced osteoarthritis of the knee can participate in this study. This means that the cartilage of the knee is affected by wear and tear. This causes pain, stiffness and swelling resulting in reduced mobility. When non-operative treatments are insufficient in treating the osteoarthritis, surgery is proposed wherein a knee arthroplasty is performed.

The goal of this study is to further optimize and personalize patient care. Additionally, the aim of the study is to investigate whether both techniques are equivalent in optimally placing the prosthesis and whether both techniques lead to comparable results.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis; Total Knee Replacement Surgery; Total Knee Arthroplasty\(TKA\)
• Intervention / Treatment: Device: Robotics Assisted TKA; Device: Augmented Reality assisted TKA

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philippe Van Overschelde, MD, MSc, MBA; Phone Number: +9 220 88 68; Email: secretariaat.heupknie@azmmsj.be

Study Locations

• Belgium
  • Oost-Vlaanderen
    • Sint-Martens-Latem, Oost-Vlaanderen, Belgium, 9830
      • Recruiting
      • Medisch Centrum Latem
      • Contact: Philippe Van Overschelde, MD, MSc, MBA; Phone Number: +32 9 220 88 68; Email: secretariaat.heupknie@azmmsj.be
      • Contact: Cynthia Lapierre, MSc; Phone Number: +32 9 220 88 68; Email: cynthia.lapierre@mijnziekenhuis.be
      • Contact: Philippe Van Overschelde, MD, MSc, MBA
      • Contact: Pieter Vansintjan, MD, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects from 18 years up to 85 years old
• Patients eligible and planned for a primary Total Knee Arthroplasty
• Patients willing to sign the informed consent form (ICF) for participating in this study
• Indication of surgery is primary osteoarthritis

Exclusion Criteria:

• Revision knee surgery
• Other medical conditions contributing to the rehabilitation process of the TKA according to the surgeon, such as Parkinson's Disease, dementia, multiple sclerosis and cerebral vascular accident
• The patient received a TKA within the last three months or has a TKA planned in the next three months, for the contralateral knee
• Patient is participating in another clinical trial
• Patient is not able to understand Dutch, French or English
• Patients who did not meet all of the inclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Skywalker; SkywalkerTM Robotics Assisted TKA using Evolution Medial Pivot Knee	Device: Robotics Assisted TKA; Skywalker Robotics Assisted TKA using Evolution Medial Pivot Knee; Other Names: Skywalker Robotics Assisted TKA
Active Comparator: Pixee Knee+; PIXEE Knee+ TKA using Evolution Medial Pivot Knee	Device: Augmented Reality assisted TKA; Pixee Knee+ assisted TKA using Evolution Medial Pivot Knee; Other Names: Pixee Knee+ TKA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
radiographic alignment and positioning of the implant on full-leg standing X-Rays	To evaluate the radiographic alignment and positioning of the implant on full-leg standing X-Rays at a minimum of 1 year follow up between two TKA assistive technologies. These results will be compared with the intraoperative settings for alignment and positioning of the implant.	1 year follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and clinical outcomes of assistive TKA technologies	Percentage change from baseline in activity parameters measured by a wearable device and clinical status measured by patient reported outcome measurements (PROM) at 6 weeks, 3 months, 6 months, 1 year and 2 years after TKA surgery. Safety will be assessed based on the incidence of treatment-related complications (e.g., wound complications, infection, nerve injury, peri-prosthetic fracture, urinary tract infection, deep vein thrombosis and pulmonary embolism ) as reported by patients and documented in medical records.	2 year follow-up
Activity parameters	Percentage change from baseline in activity parameters (e.g., step count, activity types, amount of activities) measured by a wearable device, daily questionnaires and measured by the UCLA activity score at 6 weeks, 3 months, 6 months, 1 year and 2 years after TKA surgery.	2 year follow-up

Collaborators and Investigators

• Sponsor: Medisch Centrum Latem
• Collaborators: MicroPort Orthopedics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: December 5, 2024
• First Submitted That Met QC Criteria: March 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Robotics; Total Knee Arthroplasty (TKA); Knee Osteoarthritis; Augmented Reality; Assistive Technologies
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: MMS.2024.021; B0172024000001 (Other Identifier: AZMM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes