Robotic Assisted vs Custom Made Total Knee Arthroplasty
NCT ID: NCT06280352
Last Updated: 2025-01-28
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
120 participants
INTERVENTIONAL
2024-03-01
2027-04-30
Brief Summary
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* Which implant/philosophy yields better clinical outcomes?
* Which implant/philosophy yields better satisfaction?
* Which system is more OR efficient? Participants will be followed for 2 years postoperatively.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Custom made Total Knee Arthroplasty
Implant used is a patient specific custom made total knee Origin (Symbios, Symbios Orthopédie SA, Avenue des Sciences 1, 1400 Yverdon-les-Bains, Switzerland)
Custom made Total Knee Arthroplasty
Total knee replacement, patient specific custom made total knee Origin (Symbios, Symbios Orthopédie SA, Avenue des Sciences 1, 1400 Yverdon-les-Bains, Switzerland)
Functionally aligned robotically assisted total knee arthroplasty
Total Knee Implant Triathlon (Stryker, Kalamazoo, Michigan, U.S.) implanted using MAKO Rio Robotic Arm (Stryker)
Functionally aligned robotically assisted total knee arthroplasty
Total knee replacement, Total Knee Implant Triathlon (Stryker, Kalamazoo, Michigan, U.S.) implanted using MAKO Rio Robotic Arm (Stryker), using functional alignment strategy
Interventions
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Custom made Total Knee Arthroplasty
Total knee replacement, patient specific custom made total knee Origin (Symbios, Symbios Orthopédie SA, Avenue des Sciences 1, 1400 Yverdon-les-Bains, Switzerland)
Functionally aligned robotically assisted total knee arthroplasty
Total knee replacement, Total Knee Implant Triathlon (Stryker, Kalamazoo, Michigan, U.S.) implanted using MAKO Rio Robotic Arm (Stryker), using functional alignment strategy
Eligibility Criteria
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Inclusion Criteria
* The patient requires a primary total knee replacement
* Patient is deemed appropriate for a cruciate retaining knee replacement
* The patient has a primary diagnosis of osteoarthritis (OA)
* The patient has intact collateral ligaments
* The patient is able to undergo CT scanning of the affected limb
* The patient has signed the study specific, ethics-approved, informed consent document
* The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations
Exclusion Criteria
* Patient has had a previous osteotomy around the knee
* The patient is morbidly obese (BMI \> 41)
* The patient has a deformity which will require the use of stems, wedges or augments
* The patient has a varus deformity ≥ 15°
* The patient has a valgus deformity \>3°
* The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device
* The patient is unable to speak German
* The patient is pregnant
40 Years
90 Years
ALL
No
Sponsors
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Austrian Workers Compensation Board Styria
OTHER
Responsible Party
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Antonio Klasan
Assistant Professor, MD, PhD, EMBA
Locations
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AUVA UKH Steiermark Standort Graz
Graz, Styria, Austria
AUVA UKH Steiermark Standort Kalwang
Kalwang, Styria, Austria
Countries
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Central Contacts
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Facility Contacts
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Antonio Klasan, MD, PHD, EMBA
Role: primary
Antonio Klasan, MD, PhD, EMBA
Role: primary
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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AUVA_Knieathlon_2024
Identifier Type: -
Identifier Source: org_study_id
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