Flexion with the Journey II BCS Total Knee System. A Prospective, Non-randomized, Consecutive Series, Observational Study. - Flexion with the Journey II BCS Total Knee System

Sint Maartenskliniek0 个研究点目标入组 62 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•Patient presents with non-inflammatory knee osteoarthritis (radiologically confirmed), requiring total knee arthroplasty
•Patient is 40 to 70 years of age, inclusive
•Patient plans to be available for follow-up through two years postoperative
•Patient is in stable health and is free of or treated for cardiac, pulmonary, haematological, or other conditions that would pose excessive operative risk
•Patient has <10 degrees fixed (non-correctable) varus or valgus deformity
•Orthopaedic surgeon is member of the Knee Reconstruction Unit SMK

•Patient is known to have insufficient femoral or tibial bone stock
•Patient has a BMI >35
•Patient*s expected physical activity after surgery is 2 or less on the UCLA Activity Scale
•Patient has had previous hip or knee replacement surgery in the last 6 months
•Patient is planned to have additional hip or contralateral knee replacement in the next 6 months
•Patient has had major, non-arthroscopic surgery to the study knee, including osteotomy around the knee
•Patient has an active, local infection or systemic infection
•Patient has physical, emotional or neurological conditions that would compromise compliance with postoperative rehabilitation and follow-up
•Patient has grade 3 collateral ligament insufficiency (complete tear of ligament)
•Patient has knee flexion <90 degrees
•Patient has fixed flexion deformity >10 degrees
•Patient has rheumatoid arthritis, any autoimmune disorder or immunosuppressive disorder
•Patient is pregnant or plans to become pregnant during course of study
•Patient has a known sensitivity to materials in the device and/or cutting blocks
•Patient has >30 degrees extension deficit

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