NCT01514318已完成不适用
A Long-term Follow Up Study of the Revelation™ Hip Stem
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Survivorship of the Device
研究概览
简要总结
The purpose of this study is to obtain long-term (10+ yrs) clinical and patient outcomes data on patients who received the Revelation Hip Stem prior to 2002.
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
- •Subjects must have received the Revelation™ Hip Stem as part of a total hip arthroplasty prior to
- •Surgery must have been a primary total hip replacement
- •Subject must have received only one primary hip replacement per hospitalization
- •Subject must have had a diagnosis of inflammatory tissue disorder, osteoarthritis, post-traumatic arthritis/secondary arthritis or avascular necrosis
- •Subject must be willing and able to sign the informed consent document
排除标准
- •Subject must not have had any previous hip implants (hemi or total joint)
- •Subject has a mental condition that may interfere with the ability to give an informed consent (i.e., severe mental retardation such that the subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
- •Subject is a prisoner
- •Subject is pregnant
结局指标
主要结局
Survivorship of the Device
时间窗: 10 year
The subject meets the inclusion/exclusion criteria of the study and received a Revelation Hip Stem prior to 2002 that has survived intact without any type of surgery to revise or remove parts or the whole prosthesis.
次要结局
- Western Ontario McMaster Arthritis Index (WOMAC)(10 year)
- Harris Hip Score(10 year)
研究者
研究点 (1)
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