NL-OMON52817招募中4 期
A Clinical Randomized Controlled RSA Trial Comparing the Cemented ATTUNE (S+Tibia tray) Fixed Bearing Cruciate Retaining Knee System with the Cemented PFC Sigma Fixed Bearing Cruciate Retaining Knee System - RSA RCT: ATTUNE S+ TKA versus Sigma TKA
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 70
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
- •General: All consecutive patients (*usual care*) are included to prevent
- •selection bias in the migration analysis.
- •Consent: Patient is capable of giving informed consent and expressing a
- •willingness to comply with this study
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
- •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).
研究者
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