NCT02097901暂停不适用
Microfracture in Rotator Cuff Injury Repair
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH)
研究概览
简要总结
The hypothesis is that microfractures in the footprint of the humerus will aid to improve the tendon healing to the bone. The aim of the study is to investigate whether the use of microfractures at the footprint of the rotator cuff will improve the tendon healing when reinserted. Patients undergoing surgery for a rotator cuff injury will be randomised to repair with or without microfracture.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over the age of 18 with a full thickness rotatorcuff rupture.
排除标准
- •Isolated rupture of the subscapularis
- •Tendon atrophia
- •Goutallier grade 3-4 fatty degeneration
- •Fracture surgery in same shoulder
- •Inflammatory or neurologic affection of shoulder
- •Other disabling disease
- •Unwilling to participate in study
结局指标
主要结局
Change in Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH)
时间窗: 0, 3 and 12 months
Standardized questionnaire
Change in Western Ontario Rotator Cuff Index (WORC)
时间窗: 0, 3 and 12 months
Standardized questionnaire
次要结局
- MRI integrity of the rotatorcuff(12 months)
研究者
Morten S. Wad
M.D
Zealand University Hospital
研究点 (2)
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