RobAR Study: Comparison of Image Based Robotic TKA vs Imageless Augmented Reality-Assisted TKA

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
Medisch Centrum Latem
RECRUITING
Sint-martens-latem
Contact Information
Primary
Philippe Van Overschelde, MD, MSc, MBA
secretariaat.heupknie@azmmsj.be
+9 220 88 68
Time Frame
Start Date: 2024-07-18
Estimated Completion Date: 2027-10-01
Participants
Target number of participants: 250
Treatments
Active_comparator: Skywalker
SkywalkerTM Robotics Assisted TKA using Evolution Medial Pivot Knee
Active_comparator: Pixee Knee+
PIXEE Knee+ TKA using Evolution Medial Pivot Knee
Sponsors
Leads: Medisch Centrum Latem
Collaborators: MicroPort Orthopedics Inc.

This content was sourced from clinicaltrials.gov