Primary stability of fully cemented LEGION HK Hinge Knee System in revision total knee arthroplasty measured with RSA - Legion Hinged RSA

Sint Maartenskliniek0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

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•- Patient requires a revision total knee replacement and the Legion HK system is indicated in this patient.
•- Patient is willing to consent to participate in the study by signing and dating an IRB-approved consent form.
•- Patient plans to be available for follow-up through two years postoperative.
•- Patient is in stable health and is free of or treated and stabilized for cardiac, pulmonary, haematological, or other conditions that would pose excessive operation risk.

•- Patient has a BMI >40.
•- Patient has an active, local infection or systemic infection.
•- Patient is unable to come/return to the hospital or has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up (e.g.: drug or alcohol abuse, serious mental illness, or general neurological conditions such as Parkinson, Multiple sclerosis, etc.).
•- Patient has an immunosuppressive disorder (chronic condition characterized by markedly inhibited ability to respond to antigenic stimuli.) Examples of such conditions include patients who are on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses), patients with acquired immunodeficiency syndrome (AIDS) or auto-immune diseases (including inflammatory arthritis).
•- Patient has a known sensitivity to materials in the device.

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