Combined Prospective / Retrospective, Open, Non-randomized, Non-interventional Post Market Clinical Follow-Up of the BPK-S Integration System (Co28Cr6Mo) Used for Primary Total Knee Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Patient relevant benefit after 5 years
研究概览
简要总结
Patients who received a total knee endoprosthesis BPK-S Integration between 2011 and 2013 will be invited to participate in this PMCF study provided sufficient source data documentation is available regarding preoperative, intraoperative and early postoperative follow-up assessments.
Only patients providing written informed consent prior to any study data collection can take part in the study.
Preoperative, intraoperative and early postoperative data (3 months, 1 year and 2 years after implantation) will be collected retrospectively. Additional long-term follow-up of one visit (year 7 after implantation) will be documented prospectively.
Only parameters assessed in clinical standard care for follow-up (implant control) visits will be collected for this PMCF study.
Radiological assessment of the implanted prosthesis will only be conducted if medically indicated according to the investigator. No additional study related assessment will be performed.
Only anonymized data will be used in this observational study to protect patient privacy. No personally identifiable information will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
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
- •Patients that received a total primary knee endoprosthesis BPK-S Integration (Co28Cr6Mo) between 2011 and 2013
- •Patients that agree to participate and give written informed consent to the anonymized retrospective and prospective data collection within the study
排除标准
- •No study specific exclusion criteria are defined for this PMCF study.
结局指标
主要结局
Patient relevant benefit after 5 years
时间窗: 7 years
improvement of KSS-Score by at least one category as compared to preoperative basic assessment
次要结局
- Revision Number(7 years)
- Revision Reason(7 years)
- Patient relevant benefit as measured by American Knee Society Score(1 year)
- Safety parameters(7 years)
- Implant Loosening Number(7 years)
- Implant Loosening Reason(7 years)
- Surgery Parameters(Day 0 = day of surgery)