RSA and Clinical Comparison of Anatomical and Mechanical Alignment in Total Knee Replacement (NCT02256904) | Clinical Trial Compass
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RSA and Clinical Comparison of Anatomical and Mechanical Alignment in Total Knee Replacement
Canada134 participantsStarted 2015-04-13
Plain-language summary
Current practice in orthopedics is to recommend TKA implantation with the femoral and tibial components perpendicular to their mechanical axis. Therefore, current surgical technique does not replicate natural knee anatomy and biomechanics. An alternative alignment method that attempts to replicate the kinematics of the knee is " kinematic alignment ". The principle behind kinematic alignment is placement of the TKA components so that the orthogonal 3-D orientation of the 3 axes that describe normal knee kinematics is restored to that of the prearthritic knee. Theoretical benefits of kinematic alignment include less ligamentous release to balance the knee intra-operatively, more rapid recovery, better range of motion (ROM), less post-operative pain, better knee biomechanics, and improved patient satisfaction. However, a major concern is that there are no mid- or long-term data on implant survivorship (absence of loosening) in TKA based on "anatomical" implantation. The investigators propose to compare the clinical results of TKA implanted with mechanical alignment (standard practice) to kinematic alignment, in a double-blind, randomized trial.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient qualifies for primary TKA
. Patient understands the study conditions
. Patient is capable of giving informed consent
Exclusion criteria
. Other joint damage of the lower limbs
. Extra-articular knee deformation of the lower limb
. Hip arthroplasty on the surgical side
. Contraindication to CT-scan
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Component migration measured with Radiostereophotometry