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NCT Number: NCT06891807

Comparison of Image Based Robotic Total Knee Arthroplasty vs Imageless Augmented Reality Assisted Total Knee Arthroplasty

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases Total Knee Arthroplasty(TKA) Total Knee Replacement Surgery

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medisch Centrum Latem

Sint-Martens-Latem, Oost-Vlaanderen, 9830, Belgium

Location status: Recruiting

Location contact

Cynthia Lapierre, MSc

CONTACT

[email protected]

+32 9 220 88 68

Philippe Van Overschelde, MD, MSc, MBA

CONTACT

[email protected]

+32 9 220 88 68

Philippe Van Overschelde, MD, MSc, MBA

PRINCIPAL_INVESTIGATOR

Pieter Vansintjan, MD, MSc

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robotics Assisted TKA

Device

Skywalker Robotics Assisted TKA using Evolution Medial Pivot Knee

Other names: Skywalker Robotics Assisted TKA

Augmented Reality assisted TKA

Device

Pixee Knee+ assisted TKA using Evolution Medial Pivot Knee

Other names: Pixee Knee+ TKA

Primary outcomes

  1. radiographic alignment and positioning of the implant on full-leg standing X-Rays

    Time frame: 1 year follow-up

    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.

Secondary outcomes

  1. Safety and clinical outcomes of assistive TKA technologies

    Time frame: 2 year follow-up

    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. Activity parameters

    Time frame: 2 year follow-up

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Philippe Van Overschelde, MD, MSc, MBA

CONTACT

[email protected]

+9 220 88 68

Sponsors and collaborators

Lead sponsor

Medisch Centrum Latem

Other

Collaborators

  • MicroPort Orthopedics Inc.

Registry information

Official study title

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

Acronym: RobAR

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 24, 2025
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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