Post-market Clinical Follow-up on the balanSys UNI Knee Prosthesis Implanted With a Spacer Block Surgical Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 主要终点
- Knee Society Score
研究概览
简要总结
The purpose of the study is the evaluation of the clinical and radiological long-term performance of the balanSys UNI fix in a multicenter routine clinical setting.
详细描述
Prospective multicenter follow-up study which examines the short- to long-term post-market clinical data on the safety and performance of the balanSys UNI fix knee prosthesis.
In total at least 100 participants in 3 clinics are included in this multicenter study.
The primary endpoint of the study is the Knee Society Score (KSS) 2 years after surgery.
The following parameters will be collected during the regular clinical and radiological follow-up: Knee Society Score, Knee and Osteoarthritis Outcome Score (KOOS), radiographic evaluation and detection of adverse events.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent form (signed by participant and investigator)
- •Primary implantation
- •Age at inclusion: Between 18 and 90 years old
- •Willing to participate in the follow-up
排除标准
- •Missing Informed consent form
- •Known or suspected non-compliance (e.g. drug or alcohol abuse)
- •Enrollment of the investigator, his/her family, employees and other dependent persons
- •Patient younger than 18 years old
- •Revision surgery
- •Does have a known allergy to metal in medical devices
- •Suffers from ACL rupture
- •Pregnancy or in the breast feeding period
研究组 & 干预措施
balanSys UNI knee prosthesis
Participants treated with a balanSys® UNI knee prosthesis
干预措施: balanSys UNI (Device)
结局指标
主要结局
Knee Society Score
时间窗: 2 years
The primary endpoint of the study is the Knee Society Score (KSS) 2 years after surgery The Knee Society Score consists of an objective score (0-100 points) and a score for function (0-100 points). A higher score means a better outcome.
次要结局
- Radiographic evaluation of lucent lines(6-12 weeks - 10 years)
- Adverse Events and Complications(6-12 weeks - 10 years)