NCT05810584已完成不适用
A Retrospective and Prospective Clinical Study Evaluating Safety and Performance of Revision LR Stem in Total Hip Arthroplasty (THA)
Limacorporate S.p.a1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2021年6月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Revision rate of the femoral component
研究概览
简要总结
This is a post-market, monocentric Retrospective and prospective, observational, open-label and baseline clinical study in order to evaluate the performance and safety of Revision LR femoral stem
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Males and females of any race
- •Age ≥ 18 years old
- •A diagnosis or condition in the target hip of one or more of the following: Primary tumors or metastasis and relative outcomes; Advanced articular destruction generated by primary degenerative or post-traumatic arthrosis or rheumatoid arthritis;Fracture or avascular necrosis; Congenital or acquired deformity; Failures of previous operations, like osteosynthesis, articular reconstruction, arthrodesis, hemi-arthroplasty or total arthroplasty; Epiphyseal region general trauma, Willingness to comply with prescribed rehabilitation and study evaluation and ability to return for follow-up visits
- •Signed study-specific Informed Consent Form
排除标准
- •Acute or chronic infections, local or systemic infections,
- •Septicaemia
- •Persistent acute or chronic osteomyelitis
- •Serious muscular, neurological or vascular diseases affecting the concerned limb
- •Mass higher than 60 kg
结局指标
主要结局
Revision rate of the femoral component
时间窗: from baseline to FU 10 Years
Revision rate of the femoral component for aseptic loosening, not resultant from a tumor recurrence.
次要结局
- Functionality evaluation(from baseline to FU 10 Years)
- Incidence of device-related adverse events or serious adverse events.(from baseline to FU 10 Years)
- Implant stability(from baseline to FU 10 Years)
研究者
研究点 (1)
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