Clinical and Radiological Results of Conservative Treatments in Proximal Humerus Fractures.Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- External rotation degree
研究概览
简要总结
In the investigators' prospective randomized study, the investigator will investigate the effect of different bandage types on functional and radiological results of proximal humerus fractures over 18 years of age, for whom conservative treatment is decided.
In recent studies, it has been shown that surgical treatment in proximal humerus fractures has a high complication rate and is also not superior to conservative treatments in terms of functional results. Therefore, the importance of conservative treatment is increasing day by day in this group of fractures, especially in elderly patients with high risk for surgery.
In these studies in the literature, the method in conservative treatment is not clearly specified, and the investigator will apply 3 different bandages to adjust the rotation of the shoulder in 3 different ways during the investigators' conservative treatment. The investigator will compare functional and radiological results between these groups.
详细描述
Proximal humerus fractures, who are admitted to the investigators' emergency department and are decided to follow conservative follow-up criteria, will be given one of 3 different bandages (velpau bandage, classical shoulder arm sling, 30 degree padded shoulder arm sling) according to the previous randomization.
Routinely, at the 2nd week, 6th week, 12th week, 6th month and 12th month outpatient clinic controls, the patients will be seen and their X-ray and clinical satisfaction status will be checked. X-rays will be taken as classical ap / lateral and true ap.
At the end of the second week, which is absolute immobilization, elbow and wrist movements will begin. Afterwards, in the 6th week, according to the state of union with deltoid strengthening, passive and active shoulder joint range of motion exercises will be started.
At the end of the 12th month, the follow-up will be terminated, and in this control, the existing joint movements will be recorded by measuring the degrees of anterior elevation, abduction, external rotation in neutral, external rotation at 90 degrees and internal rotation. In addition, in this control, the values will be noted by taking the Constant, ASES, DASH and VAS Scores.
After all these values are noted for all 3 groups, statistical analysis between groups will be made for each variable and the result will be given.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
When the treatments are completed, those who will evaluate the clinical and radiological results will not know the treatment method.
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
- •Neer type 2, 3 and 4 proximal humerus fractures suitable for conservative follow-up
- •Patients older than 18 years
排除标准
- •Previous surgery in the ipsilateral shoulder area
- •Fractured dislocation
- •Patients with open phys line
- •Patients with neurological problems affecting the upper extremity (MS, stroke, etc.)
- •Patients with fracture-induced neurovascular problems
- •Open fractures
- •Patients who require surgery for any reason while follw-up (malunion, nonunion, etc.)
结局指标
主要结局
External rotation degree
时间窗: 12 months
degrees of external rotation achieved after conservative follow-up.
次要结局
- Anterior elevation degree(12 months)
- Internal rotation degree(12 months)
- ASES Score degree(12 months)
- Abduction degree(12 months)
- Constant Score degree(12 months)
- DASH Score degree(12 months)
- VAS Score degree(12 months)
研究者
Murat Sarikas
Recident of orthopaedic surgery
Bezmialem Vakif University