NL-OMON47832已完成4 期
A Clinical Randomized Controlled RSA Trial Comparing the Cemented ATTUNE Fixed Bearing Cruciate Retaining Knee System with the Cemented PFC Sigma Fixed Bearing Cruciate Retaining Knee System - RSA RCT: ATTUNE TKA versus Sigma TKA
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Age: 21- 90 years Indications: Patient is diagnosed with osteoarthritis or
- •rheumatoid arthritis and requiring primary knee arthroplasty
排除标准
- •The patient has an a-priori risk for a posterior-stabilized total knee
- •arthroplasty.
- •Insufficiency of the posterior cruciate ligament (PCL)
- •Status after patellectomy
- •In case flexion is less than 90 degrees
- •When it is expected that the tibia cut during surgery will compromise the
- •attachment of the PCL (because of bony defects)
- •The patient is unable or unwilling to sign the Informed Consent specific to
- •this study The patient does not understand the Dutch or English language good
- •enough to participate Patients indicated for revision arthroplasty When there
- •are not enough markers visible in the baseline RSA photograph and it will not
- •improve by placing the patient in another position, the patient will
- •be excluded from the study (secondary exclusion criteria). s=fieldla
研究者
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