A Prospective Open-Label Evaluation of the Restoration® Modular System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 24
- 主要终点
- Stem Survivorship (%)
研究概览
简要总结
The purpose of this study is to demonstrate survivorship of the femoral stem at 5 years.
详细描述
The two-piece modular revision stem components are intended to be used for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. This study evaluates the System in revision cases only. The stems are intended to be used with Stryker Orthopaedics femoral heads, unipolar and bipolar components, and acetabular components. These femoral stems are designed to be press fit into the proximal femur.
In addition to demonstrating survivorship at 5 years, this study will seek to gain information on four secondary objectives: radiographic stability, Harris Hip Scores, SF-36 general well-being assessment, and safety profile.
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
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidates for cementless revision of a failed femoral prosthesis.
- •Patients willing to sign the informed consent.
- •Patients able to comply with follow-up requirements including post-operative weightbearing restrictions and self-evaluations.
- •Male and non-pregnant female patients ages 18 to 85 years of age at the time of surgery.
排除标准
- •Patients with ongoing infection.
- •Patients who are severely immunocompromised.
- •Patients who are prisoners.
结局指标
主要结局
Stem Survivorship (%)
时间窗: 5 years
Failure is defined by stem revision for any cause.
Femoral Stem Fracture
时间窗: 5 years
次要结局
- Radiographic Stability(5 years)
- Post-surgery Femoral Crack/Fracture and Subsidence Rate(Post-op to 5 years)
- Harris Hip Score(pre-op and 5 years)
- SF-36 Health Status Survey: Role - Physical(pre-op, 2 year and 5 year)