NCT02210910已完成不适用
A Randomized, Two-arm, Prospective Study to Assess the Efficacy and Safety of InSpace™ Device Implanted Over a Rotator Cuff Repair in Comparison With Rotator Cuff Repair Only
OrthoSpace Ltd.2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2012年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- The change in the Shoulder Score
研究概览
简要总结
This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ in the study population in comparison to surgical RCT repair.
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 MRI of the affected shoulder indicating full thickness large to massive RCT of at least 3cm in diameter (according to Cofield classification2) involving one or more tendons. (MRI can be done up to 6 months prior to randomization.)
- •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
结局指标
主要结局
The change in the Shoulder Score
时间窗: baseline and 6 months
次要结局
未报告次要终点
研究者
研究点 (2)
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