Multicenter, Prospective, Randomized, Comparative Study Measuring the Effects on Clinical Outcomes, Patient Satisfaction, Costs and Benefits of Combined Pre-, Intra- and Postoperative Patient Data for THA and TKA Patients Using an APP Based Sensor for Exercise Performance Before and After Operation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Aesculap AG
- 试验地点
- 2
- 主要终点
- Osteoarthritis Outcome Score
研究概览
简要总结
Multicenter, Prospective, Randomized, Comparative Study Measuring the Effects on Clinical Outcomes, Patient Satisfaction, Costs and Benefits of Combined Pre-, Intra- and Postoperative Patient Data for THA and TKA Patients Using an APP Based Sensor for Home Exercise Performance Before and After Operation
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Primary, unilateral total knee and hip replacement patients
- •Participant is min. 18 years of age
- •Participant is able and willing to provide written informed consent
- •Participant with ability to work with smart devices
- •Participant having its own device (Apple iPhone or iPad with latest iOS version or Android tablet or smart phone min. Android version 6) and are able to handle the app and/or sensor
排除标准
- •Pregnancy
- •Participant has mental in capabilities - unable to give informed consent
- •Participants who are unwilling or mentally and/or physically unable to adhere to study procedures
- •Participant is having orthopaedic co-morbidities such as: previous HTO at indexed joint or prior UKA
- •Flexion contracture > 15°
- •Varus/valgus deformity > 10°
- •Participant is having dementia or other cognitive impairment
结局指标
主要结局
Osteoarthritis Outcome Score
时间窗: 12 weeks after surgery
The Patient self-assessed Injury and Osteoarthritis Outcome Scores for Knee (KOOS) and hip (HOOS) are joint-specific instruments: The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). The HOOS evaluates both short-term and long-term consequences of hip injury. It holds 5 separate patient-relevant dimensions: Pain (P), Symptoms (S), Activity limitations daily living (ADL), Function in sport and recreation (SP) and hip related quality of life (QOL). Both scores are percentage scores from 0 to 100, 0 representing extreme problems and 100 representing no problems.
次要结局
- Course of Active Range of Motion(repeatedly from pre-op consultation until final follow-up approx. 7 months after surgery)
- Patient User Experience(at final follow-up approx. 7 months after surgery)
- Economical [time and costs](12 weeks after surgery)
- Patient satisfaction(12 weeks after surgery)
- Patient compliance(at final follow-up approx. 7 months after surgery)
- Development of Pain(repeatedly through study completion, an average of 7 months postoperatively.)
- Fatigue(at pre-operative consultation, post-operative consultation (12 weeks) and 6 months after surgery)
- Radiographic Analysis(through study completion, an average of 7 months postoperatively)
- Number of (Serious) Adverse Events(through study completion, an average of 7 months postoperatively)