Combined Microfracture Procedure Promotes Tendon Healing During Double Raw Repair for Full Tear Rotator Cuff - a Prospective Randomized Study With 2-year Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- rotator cuff re-tear rate
研究概览
简要总结
This study is a prospective randomized controlled study of Combined microfracture procedure promotes tendon healing during double raw repair for full tear rotator cuff. The patients with rotator cuff tear were randomly divided into groups before the operation. The patients were followed up before and 6 weeks, 3 months, 6 months, 12 months after surgery. In different time periods, the quantitative and qualitative indicators including pain, functional score, muscle strength, MRI performance, etc. were compared between groups at the same time period to evaluate the difference in the effect of Crimson duvet procedure with Greenhouse procedure on the treatment of rotator cuff.
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Arthroscopy confirmed small to medium full rotator cuff tear
- •Unilateral rotator cuff injury
- •Voluntarily accept randomized controlled grouping, cooperate with treatment and follow up patients
- •Young and middle-aged patients aged 20 to 60
排除标准
- •Previous shoulder surgery (incision or arthroscopy)
- •Combined with diseases of other parts of the same limb
- •Combined with Bankart injury, acromioclavicular joint disease, greater tuberosity fracture, glenoid fracture and so on
- •Bilateral onset
- •Unable or unwilling to receive clinical follow-up
结局指标
主要结局
rotator cuff re-tear rate
时间窗: 2 year postoperatively
the rotator cuff re-tear rate was measured by MRI, MRI was performed to identify the status of the tendon
次要结局
- SST (simple shoulder test)(3,6,12,24 months postoperatively)
- VAS (Visual Analogue Scale)(1,2,3,7 days postoperatively and 3,6,12,24 months postoperatively, higher scores mean a worse outcome.)
- front extension, external rotation and internal rotation strength of shoulder(6,12,24 months postoperatively)
- Constant score(3,6,12,24 months postoperatively)
- UCLA (University LosAngeles scoring system)(3,6,12,24 months postoperatively)
- ASES（American Shoulder and Elbow Surgeons'Form）(3,6,12,24 months postoperatively)
研究者
Yi Lu
Director of Sports Medicine Service of Beijing Jishuitan hospital
Beijing Jishuitan Hospital