Comprehensive Nano Post Market Data Collection
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 194
- 试验地点
- 10
- 主要终点
- Survivorship
研究概览
简要总结
This data collection project is intended to provide clinical outcomes data to engineering, marketing as well as fulfill the post market surveillance requirements of various regulatory authorities. The study will be a prospective and one-arm.
详细描述
The Comprehensive® Shoulder System with Nano humeral component is a humeral prosthesis system intended for use in total or hemi shoulder arthroplasty surgery. Total shoulder arthroplasty consists of replacement of the humeral head and glenoid. Hemi-arthroplasty consists of replacement of only the humeral head.
This project is a prospective study including one-hundred and fifty (150) anatomic and hemi cases and 44 reverse shoulders collected from up to ten (10) sites. All potential study subjects will be required to participate in the Informed Consent process.
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
- •Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- •Rheumatoid arthritis
- •Revision where other devices or treatments have failed
- •Correction of functional deformity.
- •Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate
- •Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate
排除标准
- •Infection
- •osteomyelitis
研究组 & 干预措施
Anatomic
Patients receiving the Anatomic or Hemi verison of the Comprehensive Nano.
干预措施: Comprehensive Nano (Device)
Reverse
Patients who have received the Reverse version of the Comprehensive Nano.
干预措施: Comprehensive Nano (Device)
结局指标
主要结局
Survivorship
时间窗: 10 years
Kaplan Meier method
次要结局
- Constant-Murley Score(10 years)
- X-rays evaluated for radiolucencies, osteolysis, migration and subsidence(10 years)
- ASES Score (American Shoulder and Elbow Surgeons)(10 years)
- SANE Score (Single Assessment Numeric Evaluation)(10 years)