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临床试验/ACTRN12613000936729
ACTRN12613000936729尚未招募未知

The effect of patient-matched instrumentation on degree of alignment achieved postoperatively in patients undergoing total knee replacement for osteoarthritis

Dr. Arash Nabavi0 个研究点目标入组 50 人开始时间: 2013年8月26日最近更新:
适应症

试验速览

阶段
未知
状态
尚未招募
发起方
入组人数
50

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • 1.The individual has read and understood the patient information statement (PIS) and signed a consent form specific to this study.
  • 2.The individual is over 18 years of age.
  • 3.The individual has been given a primary diagnosis of osteoarthritis.
  • 4.The individual clinically qualifies for total knee arthroplasty surgery based on physical examination and medical history.
  • 5.The individual is physically and mentally willing and able to comply with scheduled clinical and radiographic evaluations (i.e., not currently being treated for a psychiatric disorder, senile dementia, Alzheimer’s disease, alcohol or substance abuse).
  • 6.The individual does not have a systemic disease that would affect their welfare or the overall outcome of the study, is not immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
  • 7.The individual is skeletally mature.

排除标准

  • 1.The individual is unable or unwilling to read the patient information statement (PIS) and sign the consent form specific to this study.
  • 2.The individual has had a previous fracture of the femoral condyles, tibia plateau, or femora/tibial shaft.
  • 3.The individual has had a previous osteotomy around the knee.
  • 4.The individual is physically or mentally compromised (i.e., is currently being treated for a psychiatric disorder, senile dementia, Alzheimer’s disease, alcohol or substance abuse), and is unable to comply with scheduled clinical and radiographic evaluations.
  • 5.The individual has a neuromuscular or neurosensory deficiency which limits their ability to evaluate the safety and effectiveness of the device.
  • 6.The individual has an active infection within the affected joint.
  • 7.The individual has had a previous total knee replacement.
  • 8.The individual is pregnant.

研究者

发起方
Dr. Arash Nabavi

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