Comprehensive Shoulder System Database Retrieval
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Implant survivorship is assessed counting the number of implant revisions
研究概览
简要总结
This study is a retrieval of database information regarding survivorship of the Comprehensive Shoulder System family of products. The primary objective of the retrieval is to collect data that will contribute to the post market surveillance requirements for this product and will provide feedback to design engineers, support marketing efforts and publications, and answer potential questions form reimbursement agencies.
详细描述
The Comprehensive Shoulder System has been cleared by the FDA via premarket notifications. No experimental or investigational surgical techniques or devices will be used in this study. All devices and products will be used in accordance with their instructions for use and/or approved labeling. The aim of the Comprehensive Shoulder System is to improve shoulder function and reduce pain.
One site will be used for this database retrieval. The number of patients involved will depend upon the size of the Comprehensive database available at Acromion, LLC.
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
- •Must have one of the following indications:
- •Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- •Rheumatoid arthritis
- •Revision where other devices or treatments have failed.
- •Correction of functional deformity.
- •Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
- •Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
- •Need to obtain pain relief and improve function
- •Ability and willingness of the patient to follow instructions, including control of weight and activity level
- •A good nutritional state of the patient
- •The patient must have reached full skeletal maturity
排除标准
- •Absolute contraindications include infection, sepsis, and osteomyelitis.
- •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.
研究组 & 干预措施
Biomet Comprehensive Shoulder System
Subjects in need of a total shoulder arthroplasty who met the inclusion/exclusion criteria and received the Comprehensive Shoulder System.
干预措施: Biomet Comprehensive Shoulder System (Device)
结局指标
主要结局
Implant survivorship is assessed counting the number of implant revisions
时间窗: 10 years
Implant survivorship will be documented by assessing the number of implant revisions occurring throughout the course of the study.
次要结局
- Clinical Safety(10 years)
- Clinical Safety - Device Related(10 years)
- Constant Shoulder Score(10 years)