Evaluate Survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Survivorship
研究概览
简要总结
Evaluate Survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.
详细描述
The primary objective of this prospective clinical data collection is to evaluate survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate. Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes including adverse events, scapular notching, and Constant Score.
All shoulders on which data will be collected are legally marketed and none of the devices are investigational or experimental. FDA has cleared this device via Premarket Notification 510(k) K080642. This data collection effort will document the clinical outcomes of the Comprehensive® Reverse shoulders. The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts, and answer potential questions from reimbursement agencies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients / cases to be included in this study shall utilize the following inclusion criteria:
- •Comprehensive Reverse Shoulder Mini Base Plate and Mini Stem in a reverse shoulder configuration.
- •The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
- •Grossly deficient rotator cuff with severe arthropathy and/or
- •Previously failed shoulder joint replacement with a grossly deficient rotator cuff.
- •Primary total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency, or
- •Fracture total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency, or
- •Revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
排除标准
- •The exclusion criteria are the same as the indications stated in the cleared labeling for the device:
- •Absolute contraindications include infection, sepsis, and osteomyelitis.
- •Relative contraindications include:
- •Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
- •Osteoporosis.
- •Metabolic disorders which may impair bone formation.
- •Osteomalacia.
- •Distant foci of infections which may spread to the implant site.
- •Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.
结局指标
主要结局
Survivorship
时间窗: 1 year
The primary objective of this prospective clinical data collection is to evaluate survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.
次要结局
- Constant-Murley Shoulder Score(6 Months)
- Adverse Events (including dislocation)(3 year)
- Radiographic Evaluation (Plain X-ray and CT)(3 year)
- Scapular Notching(3 year)
- Radiographic Evaluation(6 Weeks)