THP AMIStem-H: Open, Retrospective and Prospective, Monocentric, Non Randomised Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 289
- 试验地点
- 1
- 主要终点
- Radiological analysis of radiolucency lines presence according to Gruen zone classification
研究概览
简要总结
Total hip replacement (THP) is widely used for hip osteoarthritis treatment. Surgeons are constantly looking to improve all aspects related to this procedure weather is improvement of implant design, instrumentation or surgical technique. Excellent clinical and radiological results were observed at medium and long term in the last years for AMIStem system.
This observational study has the objective to survey hip prosthesis stability and function of the operated hip in patients who are not exposed to surgical risks. The principal investigator will contact all patients in order to perform the follow-up visit according to standard practice. Patients operated between January 2010 and December 2011 will be invited in the study during the clinical visit organised according to standard practice. Preoperative clinical and radiological data, intraoperative details and postoperative follow-up data at 1-year will be retrospectively collected. Five-year and ten-year data will be prospectively collected after inclusion in the study.
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
- •Patient who has received a total hip arthroplasty between January 2010 and December 2011
- •Patient who has received an AMIStem H femoral component
- •Patient who have signed the information letter in order to give agreement for the clinical data treatment
排除标准
- •Minor patient
- •Pregnant or breast feeding woman
- •Any patient who cannot or will not provide informed consent for participation in the study
结局指标
主要结局
Radiological analysis of radiolucency lines presence according to Gruen zone classification
时间窗: 5 year
次要结局
- radiological assessment of femoral deformation(5 year, 10 year)
- radiological assessment of femoral stem subsidence(5 year, 10 year)
- radiological assessment of cortical bone density(5 year, 10 year)
- radiological assessment of calcar resorption(5 year, 10 year)
- Radiological analysis of radiolucency lines presence according to Gruen zone classification(10 year)