Comprehensive Reverse Shoulder: Porous Augmented Glenoid Baseplate and Mini Humeral Tray Post-Market Clinical Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 99
- 试验地点
- 6
- 主要终点
- Implant Survivorship
研究概览
简要总结
This study is a multicenter, prospective, non-randomized, non-controlled, dual cohort post market surveillance study. The primary objective of this study is to confirm the safety and performance of the Comprehensive Reverse Shoulder System when used with the Comprehensive Porous Augmented Glenoid Baseplate and/or Comprehensive Mini Humeral Tray in primary and revision reverse shoulder arthroplasty.
详细描述
The Comprehensive Reverse Porous Augmented Glenoid Baseplate and Comprehensive Mini Humeral Tray belong to the Comprehensive Reverse Shoulder Arthroplasty System. They were developed to provide patients with grossly deficient rotator cuffs with another surgical option. The aim of the Comprehensive Reverse Shoulder System is to increase shoulder function while reducing pain.
A maximum of 7 sites will contribute to this study. Enrollment of 7 sites on a global scale will allow for assessment of device consistency across different regions. Enrollment per site will not exceed 45 shoulders. 146 implants will be included in this study with competitive enrollment. All potential study subjects will be required to participate in the Informed Consent process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be 18 years of age or older.
- •Patient must be anatomically and structurally suited to receive the implants and possess a functional deltoid.
- •Patient must have a grossly deficient rotator cuff with severe arthropathy and/or a previously failed shoulder joint replacement with a grossly deficient rotator cuff.
- •Patient must be able and willing to complete the protocol required follow-up.
- •Patient must be able and willing to sign the Institutional Review Board/Ethics Committee approved informed consent.
排除标准
- •Patient is a prisoner.
- •Patient is a current alcohol or drug abuser.
- •Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
- •Patient presents with osteoporosis.
- •Patient has a metabolic disorder that may impair bone formation.
- •Patient has osteomalacia.
- •Patient has distant foci of infections which may spread to the implant site.
- •Patient has rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.
研究组 & 干预措施
Comp. Rev. Porous Augmented Glenoid
Subjects with a grossly deficient rotator cuff in need of a reverse shoulder arthroplasty who met the inclusion/exclusion criteria and received the Comprehensive Reverse Porous Augmented Glenoid.
干预措施: Comprehensive Reverse Porous Augmented Glenoid (Device)
Comp. Rev. Mini Humeral Tray
Subjects with a grossly deficient rotator cuff in need of a reverse shoulder arthroplasty who met the inclusion/exclusion criteria and received the Comprehensive Reverse Mini Humeral Tray
干预措施: Comprehensive Mini Humeral Tray (Device)
结局指标
主要结局
Implant Survivorship
时间窗: 10 years
Based on removal or intended removal of the device and determined using the Kaplan-Meier method
次要结局
- Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeon Score Patient Questionnaire.(10 years)
- Frequency and Incidence of Adverse Events(10 years)
- Radiographic Performance(10 years)