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
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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RECRUITING
NA
250 participants
INTERVENTIONAL
2024-07-18
2027-10-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Skywalker
SkywalkerTM Robotics Assisted TKA using Evolution Medial Pivot Knee
Robotics Assisted TKA
Skywalker Robotics Assisted TKA using Evolution Medial Pivot Knee
Pixee Knee+
PIXEE Knee+ TKA using Evolution Medial Pivot Knee
Augmented Reality assisted TKA
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
Augmented Reality assisted TKA
Pixee Knee+ assisted TKA using Evolution Medial Pivot Knee
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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MicroPort Orthopedics Inc.
INDUSTRY
Medisch Centrum Latem
OTHER
Responsible Party
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Philippe Van Overschelde
Dr. Philippe Van Overschelde, MD, Orthopaedic Surgeon
Locations
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Medisch Centrum Latem
Sint-Martens-Latem, Oost-Vlaanderen, Belgium
Countries
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Central Contacts
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Facility Contacts
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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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