NL-OMON35099招募中4 期
Clinical evaluation of Signature Personalized Patient Care Prospective, clinical, multicentre, randomised, double blind study - Clinical evaluation of Signature Personalized Patient Care
Orbis Medisch Centrum0 个研究点目标入组 180 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
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
- •Painful and disabled knee joint resulting from osteoarthritis
- •One or more compartments are involved, as assessed by X-ray
- •High need to obtain pain relief and improve function
- •Above 18 years old (full skeletal maturity)
- •Body-mass-index (BMI) <35
- •Ablility and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations
- •Consent form read, understood and signed by patient
排除标准
- •Active infection in knee
- •General infection
- •Distant foci of infections which may spread to the implant site
- •Failure of previous joint replacement
- •Previous major knee surgery, except for arthroscopic meniscectomy
- •Use of anticoagulants for any reason
- •Metal near knee joint (MRI-scan not possible)
- •Not able or willing to undergo MRI-scan
研究者
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