Periprosthetic Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Bone mineral density of surrounding proximal femur according to Gruen zones
研究概览
简要总结
The purpose of this study is to determine if there is a difference in stress shielding and bone resorption of the proximal femur in two anatomical stem total hip designs.
详细描述
Stress shielding related bone resorption in the proximal femur after total hip arthroplasty continues to be a problem. The purpose of this prospective, randomized study was to evaluate which of the two anatomical stem designs achieved a more physiological load transfer by assessing bone mineral changes in the proximal femur after stem implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoarthritis of hip joint requiring total hip arthroplasty
排除标准
- •Neurologic disorders affecting motor function of lower extremity
- •foot and ankle disorders limiting ambulation of the patient
- •Patients with bone metabolic disorders other than osteoporosis which prevents normal bone metabolism
- •Multi-systemic inflammatory arthritis which debilitates patients other than hip joint.
研究组 & 干预措施
Stemless femoral component
Stemless PROXIMA femoral component
干预措施: Stemless femoral component (Device)
Stemmed femoral component
IPS, proximal anatomical fit stemmed femoral component
干预措施: IPS, Depuy cementless femoral stem (Device)
结局指标
主要结局
Bone mineral density of surrounding proximal femur according to Gruen zones
时间窗: At least 2years after surgery
次要结局
- Harris hip score(2 years)