Multicenter Prospective Registry for Periprosthetic Fractures After Hip or Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 13
- 主要终点
- Classification of the fracture
研究概览
简要总结
This registry supports international data collection and research on PPFx treatments after hip and knee arthroplasty.
A registry such as this ultimately aims to provide far-reaching benefits to society including reduced morbidity and mortality, improved patient safety, improved quality of care and medical decision-making, reduced medical spending, and advances in orthopaedic science.
详细描述
To close the gap of missing clinical evidence regarding the treatment of periprosthetic fractures after arthroplasty of the hip or the knee with osteosynthesis.
To drive further study hypotheses and to answer unforeseen questions.
Main questions to be answered by the registry include (but are not exclusive) the following:
- Influence of implants on outcome
- Influence of surgical techniques on outcome
- Influence of bone grafting on outcome
- Identification of risk factors for failure
- Identification of postoperative rehabilitation programs and its possible influence on the outcome
- Influence of fracture type on outcome
- To serve as a comparative dataset for future studies with improved implants and techniques
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Post-operative PPFx after total or hemi hip or total or unicondylar knee arthroplasty (including the acetabulum, femur, patella and proximal tibia) requiring
- •osteosynthesis alone or
- •component revision plus plate/nail osteosynthesis
- •Informed consent obtained, i.e.:
- •Ability of the patient or assigned representative to understand the content of the patient information / Informed Consent Form
- •Signed and dated EC / IRB approved written informed consent
- •Ability to attend post-operative follow up visits
排除标准
- •Pregnancy or women planning to conceive within the study period
结局指标
主要结局
Classification of the fracture
时间窗: Pre-operatively (Day -1)
Classification of the fracture using the UCS and some parts of the AO/OTA fracture classification system.
次要结局
- Rehabilitation program(Up to 12 months)
- Function of hip or knee(Up to 12 months)
- Fracture healing(Up to 12 months)
- pain visual analog scale (VAS) and pain medication(Up to 12 months)
- Fracture mechanism(Pre-operatively (Day -1))
- Health related quality of life(Up to 12 months)