Actively Recruiting
Comparison of Image Based Robotic Total Knee Arthroplasty vs Imageless Augmented Reality Assisted Total Knee Arthroplasty
Led by Medisch Centrum Latem · Updated on 2025-03-24
250
Participants Needed
1
Research Sites
167 weeks
Total Duration
On this page
Sponsors
M
Medisch Centrum Latem
Lead Sponsor
M
MicroPort Orthopedics Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Comparison of Image Based Robotic Total Knee Arthroplasty vs Imageless Augmented Reality Assisted Total Knee Arthroplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Medisch Centrum Latem
Sint-Martens-Latem, Oost-Vlaanderen, Belgium, 9830
Actively Recruiting
Research Team
P
Philippe Van Overschelde, MD, MSc, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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