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Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment

RecruitingNAAges 18 Years - anyAllExactech
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to evaluate both clinical measures and PROMs in patients undergoing total knee arthroplasty (TKA) using restricted inverse kinematic alignment (iKA) compared to mechanical alignment (MA), both using surgical navigation assistance.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Subjects must meet all of the following inclusion criteria to be included in the study: 1. Subject must be at least 18 years of age at the time of the surgery (skeletally mature) 2. Subject will receive a Optetrak Logic® CR device per the "Indications for Use" described above 3. Subject must be willing to comply with the pre-operative and post-operative visit requirements 4. Subject must be willing and able to provide written informed consent for participation in the study Exclusion Criteria: * Subjects will be excluded from the study if they meet any of the following exclusion criteria: 1. Subject with a suspected or confirmed systemic infection and/or a secondary remote infection 2. Subject without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis 3. Subject without sufficient soft tissue integrity to provide adequate stability 4. Subject with either mental or neuromuscular disorders that do not allow control of the knee joint 5. Subjects whose weight, age, or activity level might cause extreme loads and early failure of the system 6. Subject is participating in another drug or device study other than knee replacement within the last three (3) months 7. Subject has behavioral and/or mental issues that may interfere with their ability to follow post-operative instructions 8. Subject is a prisoner 9. Subject is pregnant 10. Subject is undergoing radiation therapy where the targeted field involves the knee joint 11. Subjects with malignancy involving proximal tibia, distal femur, or knee joint 12. Subjects undergoing active administration of chemotherapy
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What it tests

  • Optetrak Logic CR Knee System
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Where

1 site
Fundacio Mutua de Terrassa per a la Docenia i Recera Biomedica i Social, F.P.C.
Barcelona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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