ChiCTR2000032843 版本V1.0 版本创建时间2020/05/13 09:12:25 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2000032843 

最近更新日期：

Date of Last Refreshed on：

 2020-05-13 09:12:12 

注册时间：

Date of Registration：

 2020-05-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

To cast or not to cast distal radius fractures in the elderly

Public title：

To cast or not to cast distal radius fractures in the elderly

注册题目简写：

English Acronym：

研究课题的正式科学名称：

A Randomized Control Trial for Comparing the Patient Reported Outcomes in Distal radius Fractures managed by either cast immbolization or volar locking plate in the edlderl spinal anesthesia

Scientific title：

A Randomized Control Trial for Comparing the Patient Reported Outcomes in Distal radius Fractures managed by either cast immbolization or volar locking plate in the edlderl spinal anesthesia

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：

DHA Phase 7

研究负责人通讯地址：

House 117 Khayaban-e-Rizwan

Applicant address：

DHA Phase 7

Study leader's address：

House 117 Khayaban-e-Rizwan

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 JPMC GOVERNMENT O SINDH .2-81/2015-GEN L/ 1711/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

Name of the ethic committee：

Medical Ethics Review Board

伦理委员会批准日期：

Date of approved by ethic committee：

 2015-02-10 00:00:00

伦理委员会联系人：

Prof. Shereen Z. Bhutta

Contact Name of the ethic committee：

Prof. Shereen Z. Bhutta

伦理委员会联系地址：

Jinnah Postgraduate Medical Centre, Karachi, Pakistan

Contact Address of the ethic committee：

Jinnah Postgraduate Medical Centre, Karachi, 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：

 rnais@yahoo.com

研究实施负责（组长）单位：

Jinnah Postgraduate Medical Centre

Primary sponsor：

Jinnah Postgraduate Medical Centre

研究实施负责（组长）单位地址：

Jinnah Postgraduate Medical Centre (JPMC), Rafiqui Shaheed Road, Karachi, Pakistan

Primary sponsor's address：

Jinnah Postgraduate Medical Centre (JPMC), Rafiqui Shaheed Road, Karachi, 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)：

卡拉奇

Country：

Pakistan

Province：

Sindh

City：

Karachi

单位(医院)：

真纳研究生医学中心

具体地址：

House 117 Khayaban-e-Rizwan

Institution
hospital：

Jinnah Postgraduate Medical Centre

Address：

House 117 Khayaban-e-Rizwan

经费或物资来源：

Nil

Source(s) of funding：

Nil

研究疾病：

桡骨远端骨折  

Target disease：

Distal radius Fracture

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期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

the authors aimed to performed a randomized control trial comparing casting with plating in the elderly population with the hypothesis that plating leads to a better patient satisfaction (SF-12 form), patient reported outcomes (PROMS) and clinical outcomes at 3 months, 6 months, 1-year and 2 year time period.  

Objectives of Study：

the authors aimed to performed a randomized control trial comparing casting with plating in the elderly population with the hypothesis that plating leads to a better patient satisfaction (SF-12 form), patient reported outcomes (PROMS) and clinical outcomes at 3 months, 6 months, 1-year and 2 year time period.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

The study included patients that were 60 years and above of either gender
Other parameters for the participants to be included in the trial were an isolated distal radius fracture (extra-articular or intra-articular) presented to the authors institute within seven days from the time of injury, stable fractures, unstable fractures which were defined as
1) an inadequate initial reduction i.e. not restoring the anatomical parameters or
2) an initial loss of reduction at one week (defined as more than 10° of dorsal angulation of the distal fracture fragment, 3 mm or more shortening of ulnar variance, articular step-off of more than 2 mm)
3) comminuted distal fragment.

Inclusion criteria

The study included patients that were 60 years and above of either gender
Other parameters for the participants to be included in the trial were an isolated distal radius fracture (extra-articular or intra-articular) presented to the authors institute within seven days from the time of injury, stable fractures, unstable fractures which were defined as
1) an inadequate initial reduction i.e. not restoring the anatomical parameters or
2) an initial loss of reduction at one week (defined as more than 10° of dorsal angulation of the distal fracture fragment, 3 mm or more shortening of ulnar variance, articular step-off of more than 2 mm)
3) comminuted distal fragment.

排除标准：

Patients were excluded if they had a sustained an open fracture, bilateral fractures of the distal radius, and ipsilateral limb fractures/injuries, multiple injuries or polytrauma, if they presented more than two weeks after the injury, if the fracture extended more than 3 cm from the radiocarpal joint, impaired wrist function prior to trauma (e.g. rheumatoid arthritis, neurological disorders or previous malunion of the affected limb), if there was a contraindication to anesthesia, patients that could not complete the follow-up period, previous fractures of the wrist or patients that could not follow doctors instructions due to poor cognition such as patients with previous history of stroke or dementia.

Exclusion criteria：

Patients were excluded if they had a sustained an open fracture, bilateral fractures of the distal radius, and ipsilateral limb fractures/injuries, multiple injuries or polytrauma, if they presented more than two weeks after the injury, if the fracture extended more than 3 cm from the radiocarpal joint, impaired wrist function prior to trauma (e.g. rheumatoid arthritis, neurological disorders or previous malunion of the affected limb), if there was a contraindication to anesthesia, patients that could not complete the follow-up period, previous fractures of the wrist or patients that could not follow doctors instructions due to poor cognition such as patients with previous history of stroke or dementia.

研究实施时间：

Study execute time：

从 From 2015-02-18 00:00:00至 To 2020-04-20 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2015-03-19 00:00:00 至 To 2019-03-25 00:00:00

干预措施：

Interventions：

组别：

1

样本量：

 547

Group：

1

Sample size：

干预措施：

cast

干预措施代码：

Intervention：

cast

Intervention code：

组别：

2

样本量：

 549

Group：

2

Sample size：

干预措施：

plating

干预措施代码：

Intervention：

plating

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 巴基斯坦

省(直辖市)：

 信德 

市(区县)：

 卡拉奇 

Country：

Pakistan

Province：

Sindh

City：

Karachi

单位(医院)：

 Jinnah Postgraduate Medical Centre 

单位级别：

  

Institution
hospital：

Jinnah Postgraduate Medical Centre

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：

1 year

测量方法：

qDASH, VAS, PRWE, Mayo's wrist score

Measure time point of outcome：

1 year

Measure method：

qDASH, VAS, PRWE, Mayo's wrist score

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织：

Sample Name：

Distal Radius Fracture

Tissue：

Bone

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 60 岁 years
最大 Max age 80 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

computer-generated randomization

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

computer-generated randomization

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：

Open label

Blinding：

Open label

是否共享原始数据：

IPD sharing

是Yes

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：

not allowed

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

not allowed

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2020-05-13 09:12:12