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

NCT06891807 | Recruiting FDA Device

• 2 other identifiers: MMS.2024.021B0172024000001
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Total Knee Arthroplasty\(TKA\); Total Knee Replacement Surgery

Keywords

Total Knee Arthroplasty (TKA); Knee Osteoarthritis; Assistive Technologies; Robotics; Augmented Reality

Outcome Measures

Primary Outcomes (1)

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

  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.

  1 year follow-up

Secondary Outcomes (2)

• Safety and clinical outcomes of assistive TKA technologies

  2 year follow-up

• Activity parameters

  2 year follow-up

Study Arms (2)

Skywalker

ACTIVE COMPARATOR

SkywalkerTM Robotics Assisted TKA using Evolution Medial Pivot Knee

Device: Robotics Assisted TKA

Pixee Knee+

ACTIVE COMPARATOR

PIXEE Knee+ TKA using Evolution Medial Pivot Knee

Device: Augmented Reality assisted TKA

Interventions

Robotics Assisted TKA DEVICE

Skywalker Robotics Assisted TKA using Evolution Medial Pivot Knee

Also known as: Skywalker Robotics Assisted TKA

Skywalker

Augmented Reality assisted TKA DEVICE

Pixee Knee+ assisted TKA using Evolution Medial Pivot Knee

Also known as: Pixee Knee+ TKA

Pixee Knee+

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• Medisch Centrum Latem: lead
• MicroPort Orthopedics Inc.: collaborator

Study Sites (1)

Medisch Centrum Latem

Sint-Martens-Latem, Oost-Vlaanderen, 9830, Belgium

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Philippe Van Overschelde, MD, MSc, MBA

CONTACT

+9 220 88 68; secretariaat.heupknie@azmmsj.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Philippe Van Overschelde, MD, Orthopaedic Surgeon

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: March 24, 2025
• Study Start: July 18, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)