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A Multicentre Randomized Controlled Trial Comparing Plating with Intramedullary Nailing for Extra-articular Distal Tibial Fractures
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注册号：

Registration number：

 ChiCTR2000033174 

最近更新日期：

Date of Last Refreshed on：

 2020-05-23 02:01:44 

注册时间：

Date of Registration：

 2020-05-23 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

A Multicentre Randomized Controlled Trial Comparing Plating with Intramedullary Nailing for Extra-articular Distal Tibial Fractures

Public title：

A Multicentre Randomized Controlled Trial Comparing Plating with Intramedullary Nailing for Extra-articular Distal Tibial Fractures

注册题目简写：

English Acronym：

研究课题的正式科学名称：

A Multicentre Randomized Controlled Trial Comparing Plating with Intramedullary Nailing for Extra-articular Distal Tibial Fractures

Scientific title：

A Multicentre Randomized Controlled Trial Comparing Plating with Intramedullary Nailing for Extra-articular Distal Tibial Fractures

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：

Ejaz Ali Chaudhry 

Applicant：

Muhammad Tahir 

Study leader：

Ejaz Ali Chaudhry 

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：

+44 73 09026936

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：

 dr.aliejaz84@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：

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

Applicant address：

Department of Orthopaedics JPMC, Karachi, 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：

古尔基信托和教学医院

Affiliation of the Leader：

Ghurki Trust and Teaching Hospital

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：

 GT2984

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

Name of the ethic committee：

Institutional Review Board

伦理委员会批准日期：

Date of approved by ethic committee：

 2015-10-02 00:00:00

伦理委员会联系人：

Prof. Amer Aziz

Contact Name of the ethic committee：

Prof. Amer Aziz

伦理委员会联系地址：

巴基斯坦拉合尔古尔基信托和教学医院

Contact Address of the ethic committee：

Ghurki Trust and Teaching hospital, Lahore, 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)：

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：

关节外Pilon骨折  

Target disease：

Extra articular 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：

半随机对照 

Study design：

Quasi-randomized controlled 

研究目的：

In this multicentre randomised controlled trial we aim to assess ratings of disability 6?months postinjury in patients who have sustained a distal tibia fracture treated with either an intramedullary nail or plate and locking screw fixation. The primary objective is: To quantify and draw inferences on observed differences in the DRI between the trial treatment groups at 6 months after injury. The secondary objectives are: To quantify and draw inferences on observed differences in early functional status at 3 months and later functional status at 12 months. To quantify and draw inferences on observed differences in the radiological outcomes: non-union, mal-alignment and shortening. To identify any differences in health-related quality of life between the trial treatment groups in the first year after injury. To determine the complication rate of intramedullary nail fixation versus locking plate fixation in the first year after injury.  

Objectives of Study：

In this multicentre randomised controlled trial we aim to assess ratings of disability 6?months postinjury in patients who have sustained a distal tibia fracture treated with either an intramedullary nail or plate and locking screw fixation. The primary objective is: To quantify and draw inferences on observed differences in the DRI between the trial treatment groups at 6 months after injury. The secondary objectives are: To quantify and draw inferences on observed differences in early functional status at 3 months and later functional status at 12 months. To quantify and draw inferences on observed differences in the radiological outcomes: non-union, mal-alignment and shortening. To identify any differences in health-related quality of life between the trial treatment groups in the first year after injury. To determine the complication rate of intramedullary nail fixation versus locking plate fixation in the first year after injury.

药物成份或治疗方案详述：

Adult patients presenting at trial centres with an acute fracture of the distal tibia will be considered for inclusion. A total of 320 patients will provide 90% power to detect a difference of 8 points in Disability Rating Index (DRI) score at 6?months at the 5% level. The randomisation sequence is stratified by trial centre and age, and administered via web-based service with 1:1 treatment allocation. Baseline demographic and pre-injury functional data and radiographs will be collected using the DRI, Olerud and Molander, and EuroQol EQ-5D questionnaire. Clinical assessment, early complications and radiographs will be recorded at 6–8?weeks. Functional outcome, health-related quality of life and resource use will be collected at 3, 6 and 12?months postoperatively. The main analysis will investigate differences in DRI 6?months postsurgery, between the two treatment groups, on an intention-to-treat basis. Tests will be two-sided and considered to provide evidence for a significant difference if p values are <0.05 

Description for medicine or protocol of treatment in detail：

Adult patients presenting at trial centres with an acute fracture of the distal tibia will be considered for inclusion. A total of 320 patients will provide 90% power to detect a difference of 8 points in Disability Rating Index (DRI) score at 6?months at the 5% level. The randomisation sequence is stratified by trial centre and age, and administered via web-based service with 1:1 treatment allocation. Baseline demographic and pre-injury functional data and radiographs will be collected using the DRI, Olerud and Molander, and EuroQol EQ-5D questionnaire. Clinical assessment, early complications and radiographs will be recorded at 6–8?weeks. Functional outcome, health-related quality of life and resource use will be collected at 3, 6 and 12?months postoperatively. The main analysis will investigate differences in DRI 6?months postsurgery, between the two treatment groups, on an intention-to-treat basis. Tests will be two-sided and considered to provide evidence for a significant difference if p values are <0.05 

纳入标准：

Inclusion criteria

排除标准：

Patients will be excluded from participation in this study if:
In the opinion of the attending surgeon, there is a contraindication to intramedullary nailing;
The fracture is open;
There is a contra-indication to anaesthesia;
There is evidence that the patient would be unable to adhere to trial procedures or complete questionnaires
The fracture extends into the ankle joint (ie, intra-articular fracture).
Contraindications to intramedullary nailing are: the medullary canal is too narrow OR there is a preinjury deformity of the medullary canal OR it is not possible to achieve fixation of four cortices with screws distal to the fracture. We feel that these exclusion criteria will be easily understood by the surgeons and are in keeping with the pragmatic nature of the trial. However, we will include the specific reason in the trial screening data. For those patients withdrawing from the trial after written consent has been obtained, data obtained up until the point of withdrawal will be included in the final analysis.

Exclusion criteria：

Patients will be excluded from participation in this study if:
In the opinion of the attending surgeon, there is a contraindication to intramedullary nailing;
The fracture is open;
There is a contra-indication to anaesthesia;
There is evidence that the patient would be unable to adhere to trial procedures or complete questionnaires
The fracture extends into the ankle joint (ie, intra-articular fracture).
Contraindications to intramedullary nailing are: the medullary canal is too narrow OR there is a preinjury deformity of the medullary canal OR it is not possible to achieve fixation of four cortices with screws distal to the fracture. We feel that these exclusion criteria will be easily understood by the surgeons and are in keeping with the pragmatic nature of the trial. However, we will include the specific reason in the trial screening data. For those patients withdrawing from the trial after written consent has been obtained, data obtained up until the point of withdrawal will be included in the final analysis.

研究实施时间：

Study execute time：

从 From 2015-10-16 00:00:00至 To 2019-03-20 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2015-05-20 00:00:00 至 To 2018-10-19 00:00:00

干预措施：

Interventions：

组别：

1

样本量：

 233

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：

 242

Group：

2

Sample size：

干预措施：

Nil

干预措施代码：

Intervention：

nil

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)：

 国家康复医学研究院 

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：

1 year

测量方法：

DRI

Measure time point of outcome：

1 year

Measure method：

DRI

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

Distal Tibia fracture

组织：

Bone

Sample Name：

Distal Tibia fracture

Tissue：

Bone

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

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 method of fixation will be allocated using a secure, centralised, web-based randomisation service. The randomisation service will be available 24 h each day to facilitate the inclusion of all eligible patients.

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

The method of fixation will be allocated using a secure, centralised, web-based randomisation service. The randomisation service will be available 24 h each day to facilitate the inclusion of all eligible patients.

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：

As the type of fixation used requires clearly visible surgical scars, the patients cannot be blind to their treatment. In addition, the treating surgeons will also not be blind to the treatment, but will take no part in the postoperative assessment of the patients. The functional outcome data will be collected and entered into the trial central database via questionnaire by a research assistant/data clerk in the trial central office. The X-rays collected will be reviewed by an independent assessor.

Blinding：

As the type of fixation used requires clearly visible surgical scars, the patients cannot be blind to their treatment. In addition, the treating surgeons will also not be blind to the treatment, but will take no part in the postoperative assessment of the patients. The functional outcome data will be collected and entered into the trial central database via questionnaire by a research assistant/data clerk in the trial central office. The X-rays collected will be reviewed by an independent assessor.

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：

yes, A standard data collection and management system include a CRF and an electronic data capture

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

yes, A standard data collection and management system include a CRF and an electronic data capture

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2020-05-23 02:01:44
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