A Single Arm, Open-label, Prospective, Study to Assess the Feasibility, Efficacy and Safety of InSpace™ Device Implantation in a Procedure Under Local Anesthesia for a Treatment of Subjects With Massive, Irreparable Rotator Cuff Tear
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Change in total shoulder outcome scores (Constant and ASES)
研究概览
简要总结
The study objective is to assess the feasibility, efficacy and safety of the InSpace™ Device implantation in a surgical procedure under local anesthesia using arthroscopic and/or fluoroscopic visualization of the affected shoulder.
详细描述
A single arm, open-label, prospective, study to assess the feasibility, efficacy and safety of InSpace™ device implantation in a procedure under local anesthesia for a treatment of subjects with massive, irreparable rotator cuff tear.
Subjects with radiological confirmed massive RCT who are eligible per inclusion/exclusion criteria, will be enrolled for the study treatment.
Subjects will undergo surgical intervention under local anesthesia , fluoroscopic and/ or arthroscopic visualization of InSpace™ implantation.
Subjects will then be followed for safety and efficacy for a 24 months following the implantation.
The study objective is to assess the feasibility, efficacy and safety of the InSpace™ Device implantation in a surgical procedure under local anesthesia using arthroscopic and/or fluoroscopic visualization of the affected shoulder.
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
盲法说明
Open Label
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50 or older.
- •Positive diagnostic MRI of the affected shoulder indicating full thickness massive irreparable RCT of at least 5cm in diameter (according to Cofield classification) including fatty infiltration grade III or IV (according to classification of Goutallier).
- •Persistent pain and failure of non-operative treatment of the affected shoulder for at least 3 months.
排除标准
- •Known allergy to the balloon material
- •Evidence of significant osteoarthritis or cartilage damage in the shoulder
- •Evidence of gleno-humeral instability
- •Evidence of major joint trauma, infection, or necrosis in the shoulder
- •Major medical condition or known drug or alcohol abuses that could affect quality of life and influence the results of the study.
- •Concurrent participation in any other invasive clinical study one month prior to enrollment to the study and during the entire study period.
- •Subjects with worker's compensation claims or other litigation claims related to the shoulder being treated in the study.
研究组 & 干预措施
InSpace implantation
InSpace device implantation
干预措施: InSpace Implantation (Device)
结局指标
主要结局
Change in total shoulder outcome scores (Constant and ASES)
时间窗: 6 months post implanatation
Change in total shoulder outcome scores (Constant and ASES)at 6 month post implantattion
次要结局
- Change in Total Shoulder scores(up to 24 months post implantation)