Mini Lateral Shoulder Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Active physiotherapy with rotator cuff tear
研究概览
简要总结
The incision is very useful and easy for the direct lateral shoulder joint exposure.
详细描述
The skin incision is about 4 to 5 cm made by the distal acromial edge in sagittal plane, The dissection takes place slightly over the acromial edge proximally and over the origin of the acromial deltoid part (the middle part of deltoid origin) distally.
After clearly revealing the region of the medial deltoid origin on the acromion, the acromionic deltoid origin is skinned only; of the edge of the acromion, and that maybe accrued by electric knife pen or periosteal elevator, without exposure the clavicular deltoid origin in the front and the deltoid origin on the spine of scapula in the back, the origin of the acromial deltoid is distanced laterally and distally, where the lateral edge, the lower surface of the acromion, under acromial bursa and the rotator cuff are exposed clearly.
Throw this approach can be made acromioplasty and rotator cuff tears repair especially upper part of rotator cuff tear very easily.
For wound closure the acromionic deltoid origin is reattached to the acromial edge by long period synthetic absorbable sutures as PDS and PDO, or non absorbable sutures as Polyester suture, under skin and skin sutures are made.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 73 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients presented with Shoulder Impingement Syndrome refractory to conservative treatment and local steroid injection
- •Patients presented with Adhesive Capsulitis and Frozen Shoulder Syndrome refractory to conservative treatment and local steroid injection
- •Patients without femur head immigration on X-ray
- •Patients with injury for one month to six months maximum
排除标准
- •Patients with femur head immigration on X-ray
- •Patients with injury for more than six months
- •Un controlled diabetes mellitus type 1 and 2
- •Patients with non controlled Vascular hypertension
- •Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
- •Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization
- •Patients with history of Carpal Tunnel release surgery failure
结局指标
主要结局
Active physiotherapy with rotator cuff tear
时间窗: up to two years
after three weeks of surgery
Active physiotherapy without rotator cuff tear
时间窗: up to two years
after two weeks of surgery
Mini cosmetic incision to the shoulder
时间窗: up to two years
4 - 5 cm
Less rehabilitation time than traditional approaches
时间窗: up to two years
6 - 8 weeks
Passive physiotherapy immediately
时间窗: up to two years
next day of surgery
Less surgical procedure time than traditional approaches
时间窗: up to two years
25 minutes to 45 minutes, it's depends of rotator cuff tear if exist or not.
次要结局
- very good patients satisfaction(up to two years)
- Restore deltoid muscle strength(up to two years)