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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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注册号：

Registration number：

 ChiCTR2000033175 

最近更新日期：

Date of Last Refreshed on：

 2020-05-23 02:17:51 

注册时间：

Date of Registration：

 2020-05-23 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

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

Public title：

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

注册题目简写：

English Acronym：

研究课题的正式科学名称：

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

Scientific title：

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

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Muhammad Tahir 

研究负责人：

Muhammad Tahir 

Applicant：

Muhammad Tahir 

Study leader：

Muhammad Tahir 

申请注册联系人电话：

Applicant telephone：

 +92 33 32343828

研究负责人电话：

Study leader's
telephone：

+92 33 32343828

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 doctor.muhammad.tahir@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 doctor.muhammad.tahir@gmail.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 Jinnah Postgraduate Medical Centre

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

House 117 Khayaban-e-Rizwan, Phase 7 Ext Defence Housing Authority, Karachi, Karachi City, Sindh, Pakistan

研究负责人通讯地址：

House 117 Khayaban-e-Rizwan, Phase 7 Ext Defence Housing Authority, Karachi, Karachi City, Sindh, Pakistan

Applicant address：

House 117 Khayaban-e-Rizwan, Phase 7 Ext Defence Housing Authority, Karachi, Karachi City, Sindh, Pakistan

Study leader's address：

House 117 Khayaban-e-Rizwan, Phase 7 Ext Defence Housing Authority, Karachi, Karachi City, Sindh, Pakistan

申请注册联系人邮政编码：

Applicant postcode：

 75500

研究负责人邮政编码：

Study leader's postcode：

 75500

申请人所在单位：

巴基斯坦卡拉齐真纳教学医学中心研究生医学中心

Applicant's institution：

Jinnah Postgraduate Medical Centre

研究负责人所在单位：

巴基斯坦卡拉齐真纳教学医学中心研究生医学中心

Affiliation of the Leader：

Jinnah Postgraduate Medical Centre

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 NO.F.2-81/ GENL-2016/ 108/ JPMC

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

Medical Ethics Review Board JPMC

Name of the ethic committee：

Medical Ethics Review Board JPMC

伦理委员会批准日期：

Date of approved by ethic committee：

 2016-01-12 00:00:00

伦理委员会联系人：

Prof. Kausar Aamir

Contact Name of the ethic committee：

Prof. Kausar Aamir

伦理委员会联系地址：

Medical Ethics Review Board JPMC, House 117 Khayaban-e-Rizwan, Phase 7 Ext Defence Housing Authority, Karachi, Karachi City, Sindh, Pakistan

Contact Address of the ethic committee：

Medical Ethics Review Board JPMC, House 117 Khayaban-e-Rizwan, Phase 7 Ext Defence Housing Authority, Karachi, Karachi City, Sindh, Pakistan

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

巴基斯坦拉合尔古尔基信托和教学医院

Primary sponsor：

Ghurki Trust and Teaching hospital, Lahore, Pakistan

研究实施负责（组长）单位地址：

JALLO MORR, LAHORE-Pakistan

Primary sponsor's address：

JALLO MORR, LAHORE-Pakistan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

巴基斯坦

省(直辖市)：

信德

市(区县)：

卡拉齐

Country：

Pakistan

Province：

Sindh

City：

Karachi

单位(医院)：

巴基斯坦卡拉齐真纳教学医学中心研究生医学中心

具体地址：

Rafiqi Shaheed Road

Institution
hospital：

Jinnah Postgraduate Medical Centre

Address：

Rafiqi Shaheed Road

经费或物资来源：

Nil

Source(s) of funding：

nil

研究疾病：

Humeral shaft fractures  

Target disease：

Humeral shaft fractures

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期+II期 

Study phase：

1-2

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

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  

Objectives of Study：

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

药物成份或治疗方案详述：

Surgery group The operation was done within 14 days after the injury using open reduction and internal fixation with 4.5mm Locking Compression Plate (DePuy Synthes, Raynham, USA). The surgical approach, use of locking or non-locking screws, and use of bridging plate or dynamic compression with anatomic reduction was left at the discretion of the treating surgeon. Bracing group The functional brace (see Figure 2 C of the main publication for image) was applied in the emergency department at the time of admission if the patient tolerated the application of the brace. In a few cases the patient first had a U-splint which was changed to a functional brace within 7 days after the admission. 

Description for medicine or protocol of treatment in detail：

Surgery group The operation was done within 14 days after the injury using open reduction and internal fixation with 4.5mm Locking Compression Plate (DePuy Synthes, Raynham, USA). The surgical approach, use of locking or non-locking screws, and use of bridging plate or dynamic compression with anatomic reduction was left at the discretion of the treating surgeon. Bracing group The functional brace (see Figure 2 C of the main publication for image) was applied in the emergency department at the time of admission if the patient tolerated the application of the brace. In a few cases the patient first had a U-splint which was changed to a functional brace within 7 days after the admission. 

纳入标准：

Inclusion criteria

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.

Exclusion criteria：

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.

研究实施时间：

Study execute time：

从 From 2016-01-21 00:00:00至 To 2020-05-29 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2016-01-21 00:00:00 至 To 2019-04-17 00:00:00

干预措施：

Interventions：

组别：

1

样本量：

 100

Group：

1

Sample size：

干预措施：

Plating

干预措施代码：

Intervention：

Plating

Intervention code：

组别：

2

样本量：

 100

Group：

2

Sample size：

干预措施：

bracing

干预措施代码：

Intervention：

bracing

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 巴基斯坦

省(直辖市)：

 旁遮普 

市(区县)：

 拉合尔 

Country：

Pakistan

Province：

Punjab

City：

Lahore

单位(医院)：

 古尔基信托和教学医院 

单位级别：

  

Institution
hospital：

Ghurki Teaching Trust Hospital

Level of the institution：

国家：

 巴基斯坦

省(直辖市)：

 信德 

市(区县)：

 卡拉齐 

Country：

Pakistan

Province：

Sindh

City：

Karachi

单位(医院)：

 真纳教学医学中心研究生医学中心 

单位级别：

  

Institution
hospital：

Jinnah Postgraduate Medical Centre

Level of the institution：

国家：

 巴基斯坦

省(直辖市)：

 联邦 

市(区县)：

 伊斯兰堡 

Country：

Pakistan

Province：

Federal

City：

Islamabad

单位(医院)：

 国家康复研究院 

单位级别：

  

Institution
hospital：

National Institute of Rehabilitation Medicine (NIRM)

Level of the institution：

测量指标：

Outcomes：

指标中文名：

Patient Reported Outcomes

指标类型：

主要指标

Outcome：

Patient Reported Outcomes

Type：

Primary indicator

测量时间点：

12 months

测量方法：

qDASH

Measure time point of outcome：

12 months

Measure method：

qDASH

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 60 岁 years
最大 Max age 85 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

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)

Randomization Procedure (please state who generates the random number sequence and by what method)：

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), to ensure there are approximately equal numbers of younger and older patients in each&

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Not stated

Blinding：

Not stated

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

private message only

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

private message only

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

yes

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

yes

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2020-05-23 02:17:51
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