DRKS00013063进行中(未招募)不适用
Prospective, Open, Non-randomized, Non-interventional Explorative, Comparative, Uncontrolled Cohort Study for Post Market Clinical Follow-Up of the BPK-S Integration UC in the Variants CoCr or Ceramic as Primary Implant - 2017-02-BPK-S Comparison
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one(—)
- 性别
- All
入选标准
- •*Congenital or acquired knee joint defects/deformation
- •*Defects or malfunction of the knee joint
- •*Arthrosis (degenerative, rheumatic)
- •*Post-traumatic arthritis
- •*Symptomatic knee instability
- •*Reconstruction of flexibility
- •*Patients with metal hypersensitivity (ceramic tibia/femur)
排除标准
- •*Illnesses which can be treated without using a knee joint implant.
- •*Acute or chronic infections near the implantation
- •*Systemic diseases and metabolic disorders
- •*Serious osteoporosis
- •*Serious damage to the bone structures that impedes stable implantation of the implant components
- •*Diseases that impair bone growth, e.g. cancer, renal dialysis, osteopenia, etc.
- •*Bone tumors in the area of the implant anchoring
- •*Obesity or overweight of the patient
- •*Overload of the knee implant to be expected
- •*Abuse of medication, drug abuse, alcoholism or mental disease
- •*Pregnancy
- •*Lack of patient cooperation
- •*Sensitivity to foreign matter in the implant materials
- •*Patients under the age of 18
- •*Patients participating in another trial
研究者
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