NCT04193163终止不适用
Prospective Observational Clinical Study Conducted Over a 10-year Period on Patients Who Received the ESOP 2 Stem to Restore Joint Function, in Order to Confirm Security and Performance of the Device
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- FH ORTHO
- 入组人数
- 10
- 试验地点
- 7
- 主要终点
- Survival rate
研究概览
简要总结
This study is a post-market clinical follow-up conducted in order to collect long-term data on security and performance of the ESOP 2 stem, which is intended to be implanted in case of total hip replacement, when used in real life conditions according to the instructions for use.
详细描述
The primary objective of this study is to evaluate the security of the ESOP 2 stem by calculating the survival rate up to 10 years of follow-up.
The secondary objectives are to evaluate the security and performance of the device by assessing radiological data, gathering complications and evaluating functional score and quality of life score up to 10 years of follow-up.
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
- •Subject implanted with ESOP 2 stem in one of the following indication according to the instructions for use: hip disorders; femoral neck fracture
- •Subject who received an information form and is willing to participate in the study
排除标准
- •Contraindications described in the instructions for use
- •Usual surgical contraindications
- •Subject who is not able to express his/her non-opposition
研究组 & 干预措施
Patients receiving ESOP 2 stem
干预措施: Hip prosthesis - ESOP 2 cementless femoral stem (Device)
结局指标
主要结局
Survival rate
时间窗: 10 years post-op
次要结局
- Radiographies evaluation(immediate post-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op)
- Rate of complications(per-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op)
- Functional outcomes such as pain, mobility(pre-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op)
- Quality of life evaluation(pre-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op)
研究者
研究点 (7)
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