Comparison of Image Based Robotic Total Knee Arthroplasty vs Imageless Augmented Reality Assisted Total Knee Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Robotics Assisted TKA, Augmented Reality assisted TKA.
- Who it may be relevant to
- Registry conditions: Knee Osteoarthritis, Total Knee Arthroplasty\(TKA\), Total Knee Replacement Surgery. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
RobAR Study: Comparison of Image Based Robotic TKA vs Imageless Augmented Reality-Assisted TKA
Overview
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.
Interventions
- Device Robotics Assisted TKA
Skywalker Robotics Assisted TKA using Evolution Medial Pivot Knee - Device Augmented Reality assisted TKA
Pixee Knee+ assisted TKA using Evolution Medial Pivot Knee
Primary outcome measures
- radiographic alignment and positioning of the implant on full-leg standing X-Rays [Time frame: 1 year follow-up]
Secondary outcome measures (2)
- Safety and clinical outcomes of assistive TKA technologies [Time frame: 2 year follow-up]
- Activity parameters [Time frame: 2 year follow-up]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- Medisch Centrum Latem — Sint-Martens-Latem
Identifiers
NCT: NCT06891807 · MMS.2024.021 · B0172024000001