CTRI/2016/11/007455招募中4 期
A prospective, single arm, multi-centre, observational, real world, post marketing surveillance to evaluate implant survivorship and performance of the Freedom® Total Knee System in total knee arthroplasty. - Freedom® 400
Meril Life Sciences India Pvt Ltd0 个研究点目标入组 400 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1.Subject is male or non-pregnant female
- •aged 18 years or older at the time of
- •2.Subject is willing and able to provide
- •written Informed Consent by signing and
- •dating the IRB or EC approved Informed
- •Consent Form.
- •3.Subject is a candidate for a total knee
- •arthroplasty
- •4.Subject is willing and able to comply
- •with postoperative scheduled clinical and
- •radiographic evaluations
排除标准
- •1.Subject with a BMI greater than or equal
- •2.Subject with an active infection within
- •the affected knee joint
- •3.Subject with neuromuscular or
- •neurosensory deficiency that may limit
- •ability of the patient to evaluate the
- •safety and efficacy of the device
- •4.Subject with a known sensitivity to
- •device materials
- •5.Subject is unwilling or unable to sign
- •the Informed Consent Document.
- •6.Subject with short Life expectancy less
- •than 5 years (e.g. Cancer, HIV/AIDS)
- •7.Subject with history of deep vein
- •thrombosis or other thrombotic disorders.
- •8.Subject with conditions such as
- •Parkinsonism, loco motors ataxia, spinal
- •scoliosis or kyphosis, stroke etc. that
- •would affect their loco motors stability
- •and interfere with assessment of Range of
- •Motion of the target Knee.
- •9.Subject who, in consideration of treating
- •doctor, would not be suitable for
- •compliance of the follow up
研究者
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