A Randomized, Two-arm, Prospective, Subject Blind Study to Assess the Safety and Efficacy of InSpace™ Device in Comparison to Full Thickness Massive Rotator Cuff Repair in Subjects Scheduled for a Repair Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- The change in Shoulder Score from baseline
研究概览
简要总结
This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear .
详细描述
The effectiveness will be assessed by comparing the scores of the ASES, Constant and Quick DASH outcome questionnaires with respect to pain reduction, improvement of activity of daily living (ADL) and improvement of range of motion (ROM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Age 40 or older.
- •Positive diagnostic imaging of the affected shoulder indicating full thickness Massive RCT (according to Cofield classification) or long involving more than one tendon.
- •Persistent pain and functional disability of the affected shoulder for at least 3 months.
排除标准
- •Known allergy to the balloon material (copolymer of PLA and -θ-caprolactone).
- •Evidence of significant osteoarthritis or cartilage damage in the shoulder
- •Evidence of gleno-humeral instability
- •Previous surgery of the shoulder in the past 2 years, excluding diagnostic arthroscopy
- •Evidence of major joint trauma, infection, or necrosis in the shoulder
- •Partial-thickness tears of the rotator cuff
研究组 & 干预措施
Best Repair of torn Rotator Cuff
Subjects will undergo surgical intervention (usually arthroscopy) to perform debridement, acromioplasty if deemed necessary, long head of biceps tenotomy, and at least partial repair.
干预措施: Best Repair of torn Rotator Cuff (Procedure)
InSpace™ system
Subjects will undergo surgical intervention (usually arthroscopy or mini invasive) of debridement, acromioplasty if deemed necessary with or without long head of biceps tenotomy, and placement of the InSpace™ system.
干预措施: InSpace™ system (Device)
结局指标
主要结局
The change in Shoulder Score from baseline
时间窗: baseline and 6 months
次要结局
未报告次要终点