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

Medisch Centrum Latem

Status: Enrolling

Conditions: Total Knee Replacement Surgery; Total Knee Arthroplasty\(TKA\); Knee Osteoarthritis

Treatments: Device: Robotics Assisted TKA; Device: Augmented Reality assisted TKA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06891807

B0172024000001 (Other Identifier)

MMS.2024.021

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Skywalker

Active Comparator group

Description:

SkywalkerTM Robotics Assisted TKA using Evolution Medial Pivot Knee

Treatment:

Device: Robotics Assisted TKA

Pixee Knee+

Active Comparator group

Description:

PIXEE Knee+ TKA using Evolution Medial Pivot Knee

Treatment:

Device: Augmented Reality assisted TKA