RobAR Study: Comparison of Image Based Robotic TKA Vs Imageless Augmented Reality-Assisted TKA
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- radiographic alignment and positioning of the implant on full-leg standing X-Rays
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Skywalker
SkywalkerTM Robotics Assisted TKA using Evolution Medial Pivot Knee
Intervention: Robotics Assisted TKA (Device)
Pixee Knee+
PIXEE Knee+ TKA using Evolution Medial Pivot Knee
Intervention: Augmented Reality assisted TKA (Device)
Outcomes
Primary Outcomes
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
- Safety and clinical outcomes of assistive TKA technologies(2 year follow-up)
- Activity parameters(2 year follow-up)
Investigators
Philippe Van Overschelde
Dr. Philippe Van Overschelde, MD, Orthopaedic Surgeon
Medisch Centrum Latem