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

NCT ID: NCT06891807

Last Updated: 2025-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-18

Study Completion Date

2027-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Skywalker

SkywalkerTM Robotics Assisted TKA using Evolution Medial Pivot Knee

Group Type ACTIVE_COMPARATOR

Robotics Assisted TKA

Intervention Type DEVICE

Skywalker Robotics Assisted TKA using Evolution Medial Pivot Knee

Pixee Knee+

PIXEE Knee+ TKA using Evolution Medial Pivot Knee

Group Type ACTIVE_COMPARATOR

Augmented Reality assisted TKA

Intervention Type DEVICE

Pixee Knee+ assisted TKA using Evolution Medial Pivot Knee

Interventions

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Robotics Assisted TKA

Skywalker Robotics Assisted TKA using Evolution Medial Pivot Knee

Intervention Type DEVICE

Augmented Reality assisted TKA

Pixee Knee+ assisted TKA using Evolution Medial Pivot Knee

Intervention Type DEVICE

Other Intervention Names

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Skywalker Robotics Assisted TKA Pixee Knee+ TKA

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MicroPort Orthopedics Inc.

INDUSTRY

Sponsor Role collaborator

Medisch Centrum Latem

OTHER

Sponsor Role lead

Responsible Party

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Philippe Van Overschelde

Dr. Philippe Van Overschelde, MD, Orthopaedic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medisch Centrum Latem

Sint-Martens-Latem, Oost-Vlaanderen, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Philippe Van Overschelde, MD, MSc, MBA

Role: CONTACT

+9 220 88 68

Facility Contacts

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Philippe Van Overschelde, MD, MSc, MBA

Role: primary

+32 9 220 88 68

Cynthia Lapierre, MSc

Role: backup

+32 9 220 88 68

Other Identifiers

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MMS.2024.021

Identifier Type: -

Identifier Source: org_study_id

B0172024000001

Identifier Type: OTHER

Identifier Source: secondary_id

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