NCT02850575进行中（未招募）不适用
Etude Prospective, Multicentrique, Non contrôlée, Non randomisée, Ouverte Pour l'évaluation de la Fixation Osseuse d'Une Cupule hémisphérique, le Mpact® Double Mobilité
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- implant fixation trough IMAGIKA
研究概览
简要总结
This study aims to evaluate long term fixation of the Mpact Double Mobility cup trough IMAGIKA technology.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary hip replacement
- •patients 18 to 80 years old
- •patients who accept the follow-up schedule
排除标准
- •femoral neck fracture
- •patients requiring grafts
- •progressive local or systemic infections
- •patients presenting muscular deficiency, neuromuscular disease or vascular insufficiency of the involved limb
- •patients suffering from diseases that can compromize the recovery to independent mobility
- •patients with BMI > 40
- •patients with cognitive diseases that can compromize their participation in the study
- •patients living in geographical area not allowing the clinical follow-up to be performed
- •patients participating in other biomedical research
- •patients <18 years old
- •patients > 80 years old
- •pregnant or breast feeding women
结局指标
主要结局
implant fixation trough IMAGIKA
时间窗: 10 years
implant fixation trough IMAGIKA
次要结局
- penetration of femoral head in the polyethylene insert trough IMAGIKA(3 months, 5 and 10 years)
- complications(intraop, immediate postop, 3 months, 1, 2, 5, 10 years)
- implant survival trough Kaplan-Meier curve(3 months, 1, 2, 5, 10 years)
- implant fixation trough IMAGIKA(3 months and 5 years)
- implant stability trough standard x-ray(3 months, 1, 2, 5, 10 years)
- Harris Hip Score(preop, 3 months, 1, 2, 5, 10 years)
研究者
研究点 (2)
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