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Minimally invasive hook-assisted reduction and cephalomedullary nailing for intertrochanteric femur fractures
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注册号：

Registration number：

 ChiCTR2000038867 

最近更新日期：

Date of Last Refreshed on：

 2020-12-28 12:33:42 

注册时间：

Date of Registration：

 2020-10-08 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Minimally invasive hook-assisted reduction and cephalomedullary nailing for intertrochanteric femur fractures

Public title：

Minimally invasive hook-assisted reduction and cephalomedullary nailing for intertrochanteric femur fractures

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Minimally invasive hook-assisted reduction and cephalomedullary nailing for intertrochanteric femur fractures

Scientific title：

Minimally invasive hook-assisted reduction and cephalomedullary nailing for intertrochanteric femur 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：

cagatay tekin 

研究负责人：

burak günaydin 

Applicant：

cagatay tekin 

Study leader：

burak günaydin 

申请注册联系人电话：

Applicant telephone：

 +90 55 56164634

研究负责人电话：

Study leader's
telephone：

+90 50 57887965

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：

 cagat87@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 docburak@gmail.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 http://tip.nku.edu.tr/

申请注册联系人通讯地址：

Cizre state hospital, Sirnak state, Turkey

研究负责人通讯地址：

Namik Kemal Mah. Kampüs Cad. No:1, Merkez, Tekirdag, 59030 Tekirdag, Turkey

Applicant address：

Cizre state hospital, Sirnak state, Turkey

Study leader's address：

Namik Kemal Mah. Kampüs Cad. No:1, Merkez, Tekirdag, 59030 Tekirdag, Turkey

申请注册联系人邮政编码：

Applicant postcode：

 73200

研究负责人邮政编码：

Study leader's postcode：

 59100

申请人所在单位：

土耳其锡尔纳克州立医院

Applicant's institution：

Cizre state hospital, Sirnak state, Turkey

研究负责人所在单位：

Namik kemal university

Affiliation of the Leader：

Namik kemal university

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：

 2019.156.09.16

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：

Girisimsel Olmayan Klinik Arastirmalar Etik Kurulu//Non-Invasive Clinical Research Ethics Committee

Name of the ethic committee：

Girisimsel Olmayan Klinik Arastirmalar Etik Kurulu//Non-Invasive Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2019-09-24 00:00:00

伦理委员会联系人：

engin deniz rencber

Contact Name of the ethic committee：

engin deniz rencber

伦理委员会联系地址：

NKU GiRiSiMSEL OLMAYAN ARASTIRMALAR ETiK KuRULU//NAMIK KEMAL University faculty of medicine, Non-Invasive Clinical Research Ethics Committee

Contact Address of the ethic committee：

NKU GiRiSiMSEL OLMAYAN ARASTIRMALAR ETiK KuRULU//NAMIK KEMAL University faculty of medicine, Non-Invasive Clinical Research Ethics Committee

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +90 28 22505904

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 edrencber@nku.edu.tr

研究实施负责（组长）单位：

namik kemal university health hospital

Primary sponsor：

namik kemal university health hospital

研究实施负责（组长）单位地址：

Namik Kemal Mah. Kampüs Cad. No:1, Merkez, Tekirdag, 59030 Tekirdag, Turkey

Primary sponsor's address：

Namik Kemal Mah. Kampüs Cad. No:1, Merkez, Tekirdag, 59030 Tekirdag, Turkey

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

土耳其

省(直辖市)：

tekirdag

市(区县)：

suleymanpasa

Country：

Turkey

Province：

tekirdag

City：

suleymanpasa

单位(医院)：

namik kemal university

具体地址：

Namik Kemal Mah. Kampüs Cad. No:1, Merkez, Tekirdag, 59030 Tekirdag, Turkey

Institution
hospital：

namik kemal university

Address：

Namik Kemal Mah. Kampüs Cad. No:1, Merkez, Tekirdag, 59030 Tekirdag, Turkey

经费或物资来源：

No

Source(s) of funding：

no

研究疾病：

Intertrochanteric femur fracture  

Target disease：

Intertrochanteric femur fracture

研究疾病代码：

s72.2

Target disease code：

s72.2

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

析因分组（即根据危险因素或暴露因素分组） 

Study design：

Factorial 

研究目的：

In IFFs, it is necessary to anatomically reduce the medial hinge to perform stable osteosynthesis with an intramedullary implant. The displacement of broken fragments by strong muscles may not allow the fracture to be closed. In this study, it was aimed to evaluate hook-assisted reduction used in patients with IFFs used when reduction was difficult or the reduction provided was lost. Our hypothesis was that minimally invasive hook-assisted reduction would reduce surgical time and radiation exposure, and also improve radiologic results.  

Objectives of Study：

In IFFs, it is necessary to anatomically reduce the medial hinge to perform stable osteosynthesis with an intramedullary implant. The displacement of broken fragments by strong muscles may not allow the fracture to be closed. In this study, it was aimed to evaluate hook-assisted reduction used in patients with IFFs used when reduction was difficult or the reduction provided was lost. Our hypothesis was that minimally invasive hook-assisted reduction would reduce surgical time and radiation exposure, and also improve radiologic results.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

Patients were excluded if they had A1.1 type proximal femur fractures, collo-diaphyseal angle distortion less than 5 degrees from the opposite side, patients under 18 years, injuries present in the ipsilateral lower limb, patients with pathologic fractures, patients with follow-up less than 6 months, patients undergoing arthroplasty, and fractures fixed with implants other than intramedullary nails.

Exclusion criteria：

Patients were excluded if they had A1.1 type proximal femur fractures, collo-diaphyseal angle distortion less than 5 degrees from the opposite side, patients under 18 years, injuries present in the ipsilateral lower limb, patients with pathologic fractures, patients with follow-up less than 6 months, patients undergoing arthroplasty, and fractures fixed with implants other than intramedullary nails.

研究实施时间：

Study execute time：

从 From 2019-09-24 00:00:00至 To 2020-08-26 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2015-12-07 00:00:00 至 To 2019-07-03 00:00:00

干预措施：

Interventions：

组别：

1

样本量：

 28

Group：

1

Sample size：

干预措施：

reduction with hook

干预措施代码：

Intervention：

reduction with hook

Intervention code：

组别：

2

样本量：

 32

Group：

2

Sample size：

干预措施：

hook is not used in reduction

干预措施代码：

 non hook

Intervention：

hook is not used in reduction

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 土耳其

省(直辖市)：

 tekirdag 

市(区县)：

 suleymanpasa 

Country：

Turkey

Province：

tekirdag

City：

suleymanpasa

单位(医院)：

 namik kemal university hospital 

单位级别：

 三级 

Institution
hospital：

namik kemal university hospital

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

reduction quality

指标类型：

主要指标

Outcome：

reduction quality

Type：

Primary indicator

测量时间点：

6 months

测量方法：

collodiaphyseal angle

Measure time point of outcome：

6 months

Measure method：

collodiaphyseal angle

指标中文名：

reduction time

指标类型：

主要指标

Outcome：

reduction time

Type：

Primary indicator

测量时间点：

peroperative

测量方法：

save the operation and reduction time

Measure time point of outcome：

peroperative

Measure method：

save the operation and reduction time

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

N/A

组织：

Sample Name：

N/A

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：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 27 岁 years
最大 Max age 95 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）：

N/A

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

N/A

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

N/A

Blinding：

N/A

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

we will publish an issue of one of the most remarkable orthopaedic surgery journal at following months International Journal of Surgery

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

we will publish an issue of one of the most remarkable orthopaedic surgery journal at following months International Journal of Surgery

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：

For both groups, a statistically significant difference was found in terms of the surgical time, reduction time, radiation time, GLI (frontal and sagittal), tip-apex distance, and collo-diaphyseal angle measurements. As a result, it was determined that hook-assisted reduction reduced the duration of surgery and reduction in appropriate cases, and reduced the exposure time to radiation by decreasing the surgical time. As seen in the radiologic measurements of patients who underwent this technique, it provided more appropriate reduction, and it seemed to be a feasible technique with similar complication rates and union times.

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

For both groups, a statistically significant difference was found in terms of the surgical time, reduction time, radiation time, GLI (frontal and sagittal), tip-apex distance, and collo-diaphyseal angle measurements. As a result, it was determined that hook-assisted reduction reduced the duration of surgery and reduction in appropriate cases, and reduced the exposure time to radiation by decreasing the surgical time. As seen in the radiologic measurements of patients who underwent this technique, it provided more appropriate reduction, and it seemed to be a feasible technique with similar complication rates and union times.

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：

  2020-10-08 08:01:41
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