NCT01890733终止不适用
A Randomized, Two-arm, Prospective, Subject Blind Study to Assess the Efficacy and Safety of InSpace™ Device in Comparison to Massive Rotator Cuff Repair in Subjects Scheduled for a Repair Surgery.
OrthoSpace Ltd.1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2012年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Comparison of respose rate at each treatment arm
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 .
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 (CT arthrogram or MRI)* of the affected shoulder indicating full thickness Massive RCT of at least 5cm in diameter (according to Cofield classification) or long - narrow tears of at least 4cm2 (W>2cm and L>2cm) including fatty infiltration grade III or IV (according to classification of Goutallier) 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
结局指标
主要结局
Comparison of respose rate at each treatment arm
时间窗: 6m
The primary efficacy outcome of the study is considered as the subject response/rehabilitation rate at 6 month post implantation as assesed by the change in the Shoulder Score
次要结局
- change of total questionnaires scores from baseline to each follow-up visit.(6W, 3m, 6m , 12m ,24m)
- subjects requiring re-operation of the repaired tear at the end of the follow-up period.(24 m post implantation)
研究者
研究点 (1)
Loading locations...
相似试验
终止
不适用
InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear.Full-thickness Rotator Cuff TearNCT02208440OrthoSpace Ltd.14
终止
不适用
InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff TearRotator Cuff TearNCT02211183OrthoSpace Ltd.4
已完成
不适用
InSpace™ System Over Rotator Cuff Repair in Comparison to Repair Alone.Rotator Cuff TearNCT02210910OrthoSpace Ltd.39
已完成
不适用
InSpace™ System Implantation in a Procedure Under Local AnesthesiaRotator Cuff TearNCT02208453OrthoSpace Ltd.45
已完成
3 期
Randomized Therapy In Status EpilepticusStatus EpilepticusNCT04391569Marinus Pharmaceuticals100