ChiCTR2000032800 版本V1.0 版本创建时间2020/05/11 00:52:26 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：

 ChiCTR2000032800 

最近更新日期：

Date of Last Refreshed on：

 2020-05-11 00:50:47 

注册时间：

Date of Registration：

 2020-05-10 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Randomized Controlled Trial Comparing Open Reduction versus Ilizarov in the Management of AO Type C Pilon Fractures

Public title：

Randomized Controlled Trial Comparing Open Reduction versus Ilizarov in the Management of AO Type C Pilon Fractures

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Randomized Controlled Trial Comparing Open Reduction versus Ilizarov in the Management of AO Type C Pilon Fractures

Scientific title：

Randomized Controlled Trial Comparing Open Reduction versus Ilizarov in the Management of AO Type C Pilon Fractures

研究课题代号(代码)：

Study subject ID：

 NO.F.2-81/2015-GENL/ 3835 /JPMC

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：

Allah Rakhio Jamali 

Applicant：

Muhammad Tahir 

Study leader：

Allah Rakhio Jamali 

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：

Department of Orthopaedics JPMC, Karachi, Pakistan

研究负责人通讯地址：

Ward 14 Second Floor Surgical Builidng, Jinnah Postgraduate Medical Centre, Karachi, Pakistan

Applicant address：

Department of Orthopaedics JPMC, Karachi, Pakistan

Study leader's address：

Ward 14 Second Floor Surgical Builidng, Jinnah Postgraduate Medical Centre, Karachi, Pakistan

申请注册联系人邮政编码：

Applicant postcode：

 75510

研究负责人邮政编码：

Study leader's postcode：

 75510

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/ 3835/ 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：

Institutional Review Board, Jinnah Postgraduate Medical Centre

Name of the ethic committee：

Institutional Review Board, Jinnah Postgraduate Medical Centre

伦理委员会批准日期：

Date of approved by ethic committee：

 2015-05-03 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：

 +92 33 32101231

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, Karachi, Pakistan

Primary sponsor：

Jinnah Postgraduate Medical Centre, Karachi, Pakistan

研究实施负责（组长）单位地址：

Jinnah Postgraduate Medical Centre, Karachi, Pakistan

Primary sponsor's address：

Jinnah Postgraduate Medical Centre, 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)：

Jinnah Postgraduate Medical Centre, Karachi, Pakistan

具体地址：

Rafiqi Shaheed Road

Institution
hospital：

Jinnah Postgraduate Medical Centre, Karachi, Pakistan

Address：

Rafiqi Shaheed Road

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)：

Ghurki

具体地址：

拉合尔

Institution
hospital：

Ghurki

Address：

Lahore

经费或物资来源：

无

Source(s) of funding：

nil

研究疾病：

Pilon骨折  

Target disease：

Pilon 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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

the aim of the study is to investigate the clinical effectiveness of ORIF versus Ilizarov for the management of Type C closed pilon fractures of the distal tibia  

Objectives of Study：

the aim of the study is to investigate the clinical effectiveness of ORIF versus Ilizarov for the management of Type C closed pilon fractures of the distal tibia

药物成份或治疗方案详述：

The minimum sample required for this study was 188 with 94 individuals in each of the study arms. We up sized the sample by 10% to account for lost to follow up and avoid attrition bias. Therefore, a total of 208 patients were required to detect 8-point difference in DRI with 95% Confidence Level and 5% significance level.  

Description for medicine or protocol of treatment in detail：

The minimum sample required for this study was 188 with 94 individuals in each of the study arms. We up sized the sample by 10% to account for lost to follow up and avoid attrition bias. Therefore, a total of 208 patients were required to detect 8-point difference in DRI with 95% Confidence Level and 5% significance level.  

纳入标准：

The study included patients 18 years and older diagnosed with closed unilateral intraarticular pilon fracture of the distal tibia classified according to AO: AO 43 – C1, C2 and C3 (complete articular). Only unilateral fractures were included since problems may occur in rehabilitation with bilateral fractures which may compromise outcomes

Inclusion criteria

The study included patients 18 years and older diagnosed with closed unilateral intraarticular pilon fracture of the distal tibia classified according to AO: AO 43 – C1, C2 and C3 (complete articular). Only unilateral fractures were included since problems may occur in rehabilitation with bilateral fractures which may compromise outcomes

排除标准：

The patients were excluded if they had a prior failed fixation; ipsilateral or contralateral lower limb fractures, dislocations, or both, pathological fracture; metabolic bone disease; or if the patient is/would be unable to understand instructions for treatment or was suffering from a mental illness, injury more than 21 days since injury, pre-existing (pre-injury) skin condition which precludes to open reduction and internal fixation or if the patient had multisystem injuries (polytrauma).

Exclusion criteria：

The patients were excluded if they had a prior failed fixation; ipsilateral or contralateral lower limb fractures, dislocations, or both, pathological fracture; metabolic bone disease; or if the patient is/would be unable to understand instructions for treatment or was suffering from a mental illness, injury more than 21 days since injury, pre-existing (pre-injury) skin condition which precludes to open reduction and internal fixation or if the patient had multisystem injuries (polytrauma).

研究实施时间：

Study execute time：

从 From 2015-05-29 00:00:00至 To 2019-11-27 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2015-06-01 00:00:00 至 To 2018-05-16 00:00:00

干预措施：

Interventions：

组别：

1

样本量：

 143

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：

 141

Group：

2

Sample size：

干预措施：

Ilizarov

干预措施代码：

Intervention：

Ilizarov

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)：

 JPMC 

单位级别：

  

Institution
hospital：

JPMC

Level of the institution：

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)：

 Ghurki Teaching Trust Hospital 

单位级别：

  

Institution
hospital：

Ghurki Teaching Trust Hospital

Level of the institution：

国家：

 巴基斯坦

省(直辖市)：

 Federal 

市(区县)：

 伊斯兰堡 

Country：

Pakistan

Province：

Federal

City：

Islamabad

单位(医院)：

 NIRM 

单位级别：

  

Institution
hospital：

NIRM

Level of the institution：

测量指标：

Outcomes：

指标中文名：

DRI

指标类型：

主要指标

Outcome：

DRI

Type：

Primary indicator

测量时间点：

12

测量方法：

DRI

Measure time point of outcome：

12

Measure method：

DRI

指标中文名：

Clinical Outcome

指标类型：

主要指标

Outcome：

Clinical Outcome

Type：

Primary indicator

测量时间点：

1 year

测量方法：

American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale

Measure time point of outcome：

1 year

Measure method：

American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

No

Tissue：

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 18 岁 years
最大 Max age 60 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）：

The patients were randomly allocated to either internal fixation or external fixation by a computer-generated sequence on a non-probability consecutive basis stratified by age and fracture type. Simple randomization was used in this study and delivered by a dedicated research officer to ensure that the allocation

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

The patients were randomly allocated to either internal fixation or external fixation by a computer-generated sequence on a non-probability consecutive basis stratified by age and fracture type. Simple randomization was used in this study and delivered by a dedicated research officer to ensure that the allocation

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：

Blinding：

1:1

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 stated

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

Not stated

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2020-05-11 00:50:47