Prospective, Single-Center, Non-Controlled, Non-Randomized, Open Study Evaluating the Performance and Stability of Amistem® C
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Assess the femoral stem migration
研究概览
简要总结
Primary objective: Evaluate femoral stem migration Secondary objective: Evaluate the performance of AMIStem H Proximal Coating at 10 years after surgery; assessment of functional recovery; radiological evaluation; reporting of complications
Scores collected:
HHS, OHS, PMA, UCLA
详细描述
The main objective of the study was to evaluate the migration and performance of the AMIStem® C femoral stem at 10 years follow-up.
The primary endpoint is the measurement of femoral component migration by EBRA-FCA (The Ein Bild Roentgen Analyse-femoral component analysis, Innsbruck, Austria)
The secondary objectives of the study are:
Evaluate the performance of the AMIStem® C stem Evaluate the function of the operated hip To evaluate the quality of life To evaluate the safety of the AMIStem® C femoral stem Evaluate the postoperative stability and fixation of the hip prosthesis
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Assess the femoral stem migration
时间窗: 2 years
The primary endpoint is the measurement of femoral component migration by EBRA-FCA software (The Ein Bild Roentgen Analyse-femoral component analysis, Innsbruck, Austria) with an accuracy of ± 1.5 mm (95% percentile), a specificity of 100% and a sensitivity of 78% for the detection of a migration of more than 1.0 mm, referring to the RSA method. The EBRA-FCA method is based on the detection of 19 points on the bony femur and the femoral component, as well as two lines to determine the axis of the implant on successive radiographs of the front pelvis. The correction of the radiological enlargement is performed based on the known diameter of the prosthetic femoral component. Lengths are measured from anatomical reference points to ensure comparability of the radiographs. The change in the distance between the top of the greater trochanter and the shoulder of the prosthesis is used to measure the migration of the femoral component.
次要结局
- Radiological analysis(pre-op, 7 days, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years)
- Assess the Quality of Life of patients(pre-op, 7 days, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years)
- Assess the security of AMIStem C and collect complications(pre-op, 7 days, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years)
- Assess the postoperative stability and fixation of AMIStem C(pre-op, 7 days, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years)
- Assess the AMIStem C performance at 10 years(10 years)
- Assess the functionality of the operated hip(pre-op, 7 days, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years)