Comparison of Image Based Robotic Total Knee Arthroplasty vs Imageless Augmented Reality Assisted Total Knee Arthroplasty
Recruiting · NCT06891807 · Interventional (participants receive a specific treatment) · Lead sponsor: Medisch Centrum Latem
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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
Where it is running
1 location listed.
- Medisch Centrum Latem - Sint-Martens-Latem, Oost-Vlaanderen, Belgium