Clinical trial NCT06891807: Comparison of Image Based Robotic Total Knee Arthroplasty vs Imageless Augmented Reality Assisted Total Knee Arthroplasty
Official title: RobAR Study: Comparison of Image Based Robotic TKA vs Imageless Augmented Reality-Assisted TKA
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Total Knee Arthroplasty\(TKA\)
Total Knee Replacement Surgery
Keywords: Total Knee Arthroplasty (TKA)
Knee Osteoarthritis
Assistive Technologies
Robotics
Augmented Reality
Lead sponsor: Medisch Centrum Latem
Sponsor class: OTHER
Collaborators: name: MicroPort Orthopedics Inc.
First posted: 2025-03-24
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: radiographic alignment and positioning of the implant on full-leg standing X-Rays
timeFrame: 1 year follow-up
Secondary outcomes:
measure: Safety and clinical outcomes of assistive TKA technologies
timeFrame: 2 year follow-up
measure: Activity parameters
timeFrame: 2 year follow-up
Other outcomes:
Locations:
city: Sint-Martens-Latem
country: Belgium
facility: Medisch Centrum Latem
state: Oost-Vlaanderen
Study officials:
References: