NCT01107340进行中（未招募）不适用
AMIStem Primary Hip System Prospective Post-marketing Multi-centre Surveillance Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- Assessment of implant survivorship using Kaplan Meier curve
研究概览
简要总结
This is a multicentre post-marketing prospective study to evaluate performance and clinical outcomes of AMIIStem primary hip system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is a good candidate for a primary hip arthroplasty using AMIStem Hip System
- •Patient is willing and able to give informed consent to participate in the follow-up program
- •Patient is suitable for surgery and able to participate in the follow-up program.
- •Those presenting with disease that meets the indication for use for Medacta implants defined in the study (on-label use)
排除标准
- •Acute systemic or chronic infection
- •Skeletal immaturity
- •Severe muscular, neurological, vascular deficiency or other pathologies of the affected limb that may compromise the stability of the implant.
- •Bone condition that may compromise the stability of the implant.
- •Patient who are unwilling or unable to give consent, or to comply with the protocol and the follow-up program.
结局指标
主要结局
Assessment of implant survivorship using Kaplan Meier curve
时间窗: 10 years after surgery
次要结局
- Assessment of the patient's physical level of activity using the Oxford Hip Score(pre-op, annually post-op up to 10 years)
- Assessment of the improvement in quality of life and joint movement using the EuroQol-5D score(pre-op, annually post-op up to 10 years)
- Assessment of implant survivorship as a measure of safety using Kaplan Meier curve(6 months, 3 years, 5 years, 7.5 years, 10 years after surgery)
- Assessment of the clinical outcome following total hip replacement using the Harris Hip Score(pre-op, 6 months, 3 years, 5 years, 7.5 years, 10 years after surgery)
研究者
研究点 (4)
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