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【ChiCTR2000033175】A multicentre randomized study comparing patient reported outcomes between surgical fixation versus conservative management in humeral shaft fractures in the elderly

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基本信息

登记号

ChiCTR2000033175

试验状态

结束

药物名称

药物类型

规范名称

首次公示信息日的期

2020-05-23

临床申请受理号

靶点

适应症

Humeral shaft fractures

试验通俗题目

A multicentre randomized study comparing patient reported outcomes between surgical fixation versus conservative management in humeral shaft fractures in the elderly

试验专业题目

A multicentre randomized study comparing patient reported outcomes between surgical fixation versus conservative management in humeral shaft fractures in the elderly

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

75500

联系人通讯地址

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临床试验信息

试验目的

Our aim is to directly compare these two methods. We want to find out whether arm function and quality of life in patients with this fracture is better with the more conservative cast and brace treatment or with surgery

试验分类

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试验类型

随机平行对照

试验分期

Ⅰ期+Ⅱ期

随机化

The study will use a parallel assignment model, with 1:1 allocation of patients into each treatment arm (operative or non-operative). Randomisation will be stratified by patient age (< 75 years old or ≥ 75 years old)

盲法

Not stated

试验项目经费来源

Nil

试验范围

目标入组人数

100

实际入组人数

第一例入组时间

2016-01-21

试验终止时间

2020-05-29

是否属于一致性

入选标准

1. Aged 60 years or older; 2. Unilateral displaced humeral shaft fracture; 3. Displacement was at least the amount of the thickness of the cortex or in transverse fractures diastasis of the half of the thickness of the cortex was required; 4. The fracture was lying in a zone delimited proximally by the superior border of the pectoralis major tendon attachment and distally by the line lying 5 cm from the upper border of the olecranon fossa as evaluated from the x-ray (see Figure 2 A in the main publication for illustration); 5. The fracture was less than 10 days old; 6. The patient was willing to accept both treatment options and willing to participate in all follow-up visits; 7. Patient spoke and read fluently either Finnish or Swedish (due to language used in data forms.；

排除标准

1. Bilateral fracture; 2. Fracture type where pectoralis major and deltoid muscle tendon insertions were in different fracture fragments causing typically significant fracture gap between the fragments (see Figure 2 B in the main publication for illustration); 3. Other concomitant trauma affecting the same upper extremity (fracture, tendon injury, significant soft tissue injury); 4. Other fracture, thoracic or abdominal injury requiring surgery; 5. Open fracture; 6. Pathologic fracture; 7. Polytraumatized patient; 8. Significant vascular injury warranting operative treatment; 9. Plexus injury; 10. History of trauma of the same upper extremity causing functional deficit; 11. Trauma or condition that warranted use of walking aid (crutches, wheelchair etc.); 12. Disease that significantly affected general condition of the patient; 13. Significantly impaired ability to co-operate for any reason (substance abuse, mental disorder, dementia); 14. Operative treatment unable to be performed within 14 days of trauma; 15. Unwilling to accept both treatment methods.；

研究者信息

研究负责人姓名

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试验机构

巴基斯坦拉合尔古尔基信托和教学医院

研究负责人电话

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研究负责人邮箱

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研究负责人邮编

75500

联系人通讯地址