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临床试验/NL-OMON39918
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.

Sint Maartenskliniek0 个研究点目标入组 32 人开始时间: 待定最近更新:
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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