NCT04704700已完成不适用
Evaluate the Rotator Cuff Repair With "InSpace" VS Without "InSpace"
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Evaluate the re-rupture rate
研究概览
简要总结
Evaluate the re-rupture rate 12 months following the intervention in a group with and a group without a spacer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First intention of the rotator cuff
- •Repairable supraspinatus and infraspinatus type 2 rupture (according to the PATTE classification, tendon retraction at the top of the humeral head)
- •No surgical history
- •Patient who has given his participation agreement to participate in the observational study after information by the surgeon,
- •Patient living in France and having the capacity to answer alone to the survey.
- •Subject affiliated to a social security scheme
- •Lack of participation in another clinical study
排除标准
- •Major subject protected by law, under curatorship or tutorship
- •Known allergy to Inspace medical device materials (PLA and -θ-caprolactone copolymer)
- •Osteoporosis
- •Damaged cartilage
- •Isolated rupture of the suprascapularis
- •Glenohumeral instability
- •Pseudo-paralytic shoulder- Infection
- •Major joint trauma
- •Pregnant or breastfeeding women
研究组 & 干预措施
patient without inspace device
Placebo Comparator
干预措施: repair of a cuff tear (Device)
patient with inspace device
Active Comparator
干预措施: repair of a cuff tear (Device)
结局指标
主要结局
Evaluate the re-rupture rate
时间窗: 12 months
with radiological imaging
次要结局
- the quality of life assessed(up to 12 months)
- resumption of work(up to 12 months)
- Evaluate mobility(up to 12 months)
- Assess shoulder pain(up to 12 months)
研究者
研究点 (1)
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