Observational cohort study to assess the association between mitochondrial function and recovery after a primary total knee arthroplasty in the elderly. - Mitochondrial function and recovery

Centre for Human Drug Research0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

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•1. Male or female of 60 years of age or older.
•2. Indication for an unilateral, primary total knee arthroplasty, due to moderate to severe osteoarthritis of the knee joint (grade 3 * 4 on the Kellgren and Lawrence scale).
•3. Formerly able to walk independently.
•4. Signed informed consent prior to any study-mandated procedure.
•5. Willingness to perform the at home measurements (Withings Body and Theripear).
•6. Able to use a smart phone (iPhone or similar).

•1. History of a performed arthroplasty of the lower extremities within 12 months before study enrollment and having planned any arthroplasty of the lower extremities within 12 months after study enrollment.
•2. History (within 3 months before screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol).
•3. Concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study.
•4. Underlying chronic disease, which, in the opinion of the investigator would interfere with study participation or the validity of the measurements.

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