Prospective Observational 2 Year Follow-up on a Retrospective Cohort of Primary Unicompartmental Knee Arthroplasty (UKA) Patients Treated With Univation® X or iUni®.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Knee joint function
研究概览
简要总结
The study is designed as a monocentric, prospective, observational, comparative follow-up study based on two previously treated patient groups. The first group consists of patients treated with the patient-specific unicondylar knee implant iUni®. For that group, 30 patients will be included in the study and analyzed. The final follow-up after 24 months has already been documented by the study center. Compared to that, a consecutive series of 50 Univation® X patients will be invited for a 24 months follow-up in 2018. In total, it is planned to include 80 retrospective patients for that historical control study design.
The products under investigation were used in routine clinical practice and according to the authorized Instructions for Use (IfU). Those data that are obtained in routine clinical use will be documented in the Case Report Form (CRF).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 who underwent UKA in 2015/2016 (using one of the products under investigation)
- •Signed informed consent
排除标准
- •pregnancy
- •patients < 18 years
结局指标
主要结局
Knee joint function
时间窗: 2 years after primary implantation
Knee Society Score
次要结局
- KOOS(2 years after primary implantation)
- axis justice position(preoperative and until discharge from hospital (within 1 week postoperatively))
- radiolucent lines(2 years after primary implantation)
- tibial slope(2 years after primary implantation)