Comparison of Image Based Robotic Total Knee Arthroplasty vs Imageless Augmented Reality Assisted Total Knee Arthroplasty

NCT06891807 · tracked via the Priya Life Science Belgium tracker

Sponsor

Medisch Centrum Latem

Phase

Not applicable

Started

2024-07-18

Last updated

2025-03-24

Condition(s) studied

Knee OsteoarthritisTotal Knee Arthroplasty\(TKA\)Total Knee Replacement Surgery

Investigational drug(s) / intervention(s)

Robotics Assisted TKAAugmented Reality assisted TKA

Robotics Assisted TKA: Skywalker Robotics Assisted TKA using Evolution Medial Pivot Knee

Augmented Reality assisted TKA: Pixee Knee+ assisted TKA using Evolution Medial Pivot Knee

Study 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

Sex

ALL

Min age

18 Years

Max age

85 Years

Healthy volunteers

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 outcome measure(s)

radiographic alignment and positioning of the implant on full-leg standing X-Rays — 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.

Trial sites (1)

Facility	City	Region	Status
Medisch Centrum Latem	Sint-Martens-Latem	Oost-Vlaanderen	Recruiting

More Medisch Centrum Latem trials in Belgium

Daily Activity and Clinical Outcome Measurement of Arthrosamid® Administration in Symptomatic Knee Osteoarthritis. Active, not recruiting

Other trials for the same condition

Physica CR and Physica PS Clinical Trial Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06891807 on ClinicalTrials.gov ↗ ← All trials in Belgium