Non-Interventional Post Market Clinical Follow-up Study Excia T® Cementless EBRA Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Aesculap AG
- 试验地点
- 1
- 主要终点
- Subsidence over time of Excia T® stem (EBRA-FCA)
研究概览
简要总结
In this Post Market Clinical Follow-up Study (PMCF Study), the short-term clinical and radiological results of the cementless Excia T® prosthesis in routine clinical use shall be assessed and the migration taking place in the first 24 months evaluated.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written patient consent to study participation
- •Age > 18 years
- •Indication for primary THA with cementless Excia T® stem
排除标准
- •Pregnancy
- •THA after fracture
- •Rheumatoid arthritis
- •Systemic disorders, treated with Cortisone or other pharmaceuticals, potentially compromising the bone quality
- •Patient physically or mentally not able to follow the postoperative examination routine
结局指标
主要结局
Subsidence over time of Excia T® stem (EBRA-FCA)
时间窗: discharge (approx. 1 week postop), 3, 12 and 24 months postoperative
The subsidence of the Excia T stem will be measured with Ein-Bild-Röntgen-Analysis Femoral Component Analysis (EBRA-FCA). EBRA allows a non-invasive measurement of routinely taken A/P radiographs. Necessary is a series of at least four x-rays that can be read by the EBRA software. The whole implant must be visible on the A/P x-ray, as well as the greater and lesser trochanter. Subsidence shall be measured on the follow-up x-rays in comparison to the discharge x-rays.
次要结局
- Clinical Results over time (Harris Hip Score)(preoperative, discharge (approx. 1 week postop), 3, 12 and 24 months postoperative)
- Radiolucent lines over time(3, 12 and 24 months postoperative)
- Cortical thinning(3, 12 and 24 months postoperative)
- Hypertrophy(3, 12 and 24 months postoperative)
- Quality of Life over time (EQ-5D-5L)(preoperative, discharge (approx. 1 week postop), 3, 12 and 24 months postoperative)
- Osteolysis over time (localized bone resorption)(3, 12 and 24 months postoperative)
- Mechanical Alignment over time(discharge (approx. 1 week postop), 3, 12 and 24 months postoperative)
- Adverse Events / Serious Adverse Events(until 24 months postoperative)