NCT02615522终止不适用
Prospektive, Klinische Verlaufsuntersuchung (Post Market Follow-Up) Der primären Knieendoprothese BPK-S Integration
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Time until revision
研究概览
简要总结
Prospective, monocenter post market clinical follow-up of a primary knee replacement bearing the CE-mark.
200 subjects will be recruited and followed up for up to ten years or until revision of the primary knee endoprosthesis, whichever occurs first. Documentation of clinical and radiological parameters within the clinical routine pre-operative and post-operative at 3 and 12 months and 2, 5 and 10 years to evaluate time to revision, pain situation, knee functionality, mobility and stability.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Congenital or acquired knee joint defects/deformation or
- •Defects or malfunction of the knee joint or
- •Arthrosis (degenerative, rheumatic) or
- •Post-traumatic arthritis or
- •Symptomatic knee instability or
- •Reconstruction of flexibility or
- •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
- •Lack of patient cooperation
- •Sensitivity to foreign matter in the implant materials
- •Patients under the age of 18
- •Patients participating in another trial
结局指标
主要结局
Time until revision
时间窗: 10 years
次要结局
- Improvement of clinical situation based on Knee Society Score(3 and 12 months, 2, 5, 10 years)
- Documentation of incidents(Up to 10 Years)
研究者
研究点 (1)
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