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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Patient relevant benefit after 5 years
研究概览
简要总结
Prospective Post-Market Clinical Follow up study according to MEDDEV 2.12/2 rev2 of the European Union. Patients receiving the primary knee implant BPK-S UC as primary implant in either variant ceramic or CoCr (metal) are eligible for the study and will be followed up for 5 years after implantation or until revision of the prosthesis, whichever occurs first. Demographic data will be collected together with data regarding safety and benefit at defined timepoints (preoperative, intraoperative and at 3 months, 1 year, 2 years and 5 years after implantation).
Patients will be divided in 2 cohorts (ceramic and metal) and stratified by age.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •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
结局指标
主要结局
Patient relevant benefit after 5 years
时间窗: 5 years
improvement of KSS-Score by at least one category as compared to preoperative basic assessment
次要结局
- Patient relevant benefit as measured by American Knee Society Score(3 months, 1, 2 and 5 years)
- Patient Quality of Life(3 months, 1, 2 and 5 years)
- Revision Number(3 months, 1, 2 and 5 years)
- Patient relevant benefit as measured by Knee Osteoarthritis Outcome Score(3 months, 1, 2 and 5 years)
- Implant Loosening Number(3 months, 1, 2 and 5 years)
- Implant Loosening Reason(3 months, 1, 2 and 5 years)
- Revision Reason(3 months, 1, 2 and 5 years)