NL-OMON39918已完成3 期
Primary stability of cemented vs uncemented stems in revision total knee arthroplasty measured with RSA: a randomised controlled trial. - Cemented vs uncemented stems in revision total knee arthroplasty.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 32
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
- •- patient requires a revision of his primary total knee replacement and the Legion system with both experimental implantation techniques is indicated in this patient.
- •- patients 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 five years postoperative.
- •- patient is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological, or other conditions that would pose excessive operative risk.
- •- patient has radiologically defined Type I or Type IIa/b bone loss according to Anderson Orthopedic Research Institute Bonestock Classification.
排除标准
- •- patient has radiologically or per-operatively defined Type III bone loss according to Anderson Orthopedic Research Institute Bonestock Classification.
- •- patient has a BMI>35.
- •- patient has an active, local infection or systemic infection.
- •- patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up.
- •- patient has an immunosuppressive disorder (chronic condition characterized by markedly inhibited ability to respond to antigenic stimuli).
- •- patient has a known sensitivity to materials in the device.
研究者
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