Prospective, Multinational Pilot Study for Evaluation of the PHENO4U Data Platform in Total Knee Arthroplasty Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Aesculap AG
- 入组人数
- 600
- 试验地点
- 4
- 主要终点
- Identification of any unknown risks or side effects in Total Knee Arthroplasty by using sensors and patient apps
研究概览
简要总结
Prospective, multinational pilot study for evaluation of the Pheno4U data platform in Total Knee Arthroplasty (TKA) patients
详细描述
The study will collect data for each patient receiving an Aesculap Total Knee Arthroplasty (TKA) implant. The data set will be analyzed for critical risk factors among implant and patient data in order to optimize patient-centered therapies.
The products under investigation will be used in routine clinical practice and according to the Instructions for Use (IFU). Data obtained in routine clinical use will be collected in the Pheno4U data platform. In addition, patients are expected to answer questionnaires about their health status. Furthermore, patients are asked to use the so called "BPMpathway" sensor and application in order to measure the active Range of Motion (ROM). The sensor can also be used for pre- and postoperative training .
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
- •Patient undergoing a total knee arthroplasty with a B. Braun knee implant system
- •Signed written informed consent
- •Patient's willingness & ability to use the "BPMpathway"sensor
- •Patient's willingness & ability to use the "4Patient" application
排除标准
- •Patient age < 18 years
- •Patient not willing to participate at the further follow-up
- •Pregnancy
- •If intraoperatively an implant from a different manufacturer is used, the study patient has to be excluded from the study.
结局指标
主要结局
Identification of any unknown risks or side effects in Total Knee Arthroplasty by using sensors and patient apps
时间窗: up to 12 months postoperatively
The study will collect data for each patient receiving an Aesculap TKA implant. The data set will be analyzed for critical risk factors among implant and patient data in order to optimize patient-centered therapies
次要结局
- Change of Pain(2 weeks prior to surgery, 6 weeks postoperatively and approximately 1 year after surgery)
- Change of Hospital for Special Surgery (HSS) Knee Surgery Expectations Survey(2 weeks prior to surgery, 6 weeks postoperatively and approximately 1 year after surgery)
- Patient satisfaction(approximately 9 months after surgery)
- Change of Knee Injury and Osteoarthritis Outcome score(2 weeks prior to surgery, 6 weeks postoperatively and approximately 1 year after surgery)
- Net Promoter Score(approximately 12 months after surgery)
- Change of Depression, Anxiety and Stress Scale - 21 Items(1 week prior to surgery and 2 weeks postoperatively)
- Development of Active Range of Motion(up to 3 months after surgery)