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

FH ORTHO7 个研究点分布在 1 个国家目标入组 10 人2019年12月1日

适应症Hip Disease Hip Fractures

干预措施Hip prosthesis - ESOP 2 cementless femoral stem

概览

阶段: 不适用
干预措施: Hip prosthesis - ESOP 2 cementless femoral stem
疾病 / 适应症: Hip Disease
发起方: FH ORTHO
入组人数: 10
试验地点: 7
主要终点: Survival rate
状态: 终止
最后更新: 2个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2019年12月1日

结束日期

2022年9月1日

最后更新

2个月前

研究类型

Observational

性别

All

研究者

发起方

FH ORTHO

责任方

Sponsor

入排标准

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

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)