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2013年8月26日
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Dr. Arash Nabavi
- 入组人数
- 50
- 状态
- 尚未招募
- 最后更新
- 6年前
概览
简要总结
暂无简介。
研究者
入排标准
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.
结局指标
主要结局
未指定
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