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Reverse oblique intertrochanteric fractures fixation
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注册号：

Registration number：

 ChiCTR2000028765 

最近更新日期：

Date of Last Refreshed on：

 2020-01-03 08:23:14 

注册时间：

Date of Registration：

 2020-01-02 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Reverse oblique intertrochanteric fractures fixation

Public title：

Reverse oblique intertrochanteric fractures fixation

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Proximal femoral locking compression plate: Better fracture reduction quality and similar functional results compared to long proximal femoral nail antirotation in fixation of reverse oblique intertrochanteric fractures

Scientific title：

Proximal femoral locking compression plate: Better fracture reduction quality and similar functional results compared to long proximal femoral nail antirotation in fixation of reverse oblique intertrochanteric 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：

Mehmet Ali Talmac 

研究负责人：

Mehmet Ali Talmac 

Applicant：

Mehmet Ali Talmac 

Study leader：

Mehmet Ali Talmac 

申请注册联系人电话：

Applicant telephone：

 +90 55 55529329

研究负责人电话：

Study leader's
telephone：

+90 55 55529329

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：

 drtalmac2@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 drtalmac2@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)：

申请注册联系人通讯地址：

Halaskargazi caddesi Etfal sk. 34371, Sisli, Istanbul, Turkey

研究负责人通讯地址：

Halaskargazi caddesi Etfal sk. 34371 Sisli Istanbul Turkey

Applicant address：

Halaskargazi caddesi Etfal sk. 34371, Sisli, Istanbul, Turkey

Study leader's address：

Halaskargazi caddesi Etfal sk. 34371, Sisli, Istanbul, Turkey

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

土耳其伊斯坦布尔锡斯利哈米迪耶埃法尔医院

Applicant's institution：

Sisli Hamidiye Etfal Hospital, Istanbul, turkey

研究负责人所在单位：

土耳其伊斯坦布尔锡斯利哈米迪耶埃法尔医院

Affiliation of the Leader：

Sisli Hamidiye Etfal Hospital Istanbul, turkey

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：

 2139

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：

Health Sciences University Sisli Hamidiye Etfal Training and Research Hospital Clinical Research Ethics Committee

Name of the ethic committee：

Health Sciences University Sisli Hamidiye Etfal Training and Research Hospital Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2019-10-09 00:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

Health Sciences University Sisli Hamidiye Etfal Training and Research Hospital Clinical Research Ethics Committee

伦理委员会联系地址：

Halaskargazi caddesi Etfal sk. 34371 Sisli Istanbul Turkey

Contact Address of the ethic committee：

Halaskargazi caddesi Etfal sk. 34371 Sisli Istanbul Turkey

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：

Orthopaedics and taumatology clinic (MD MEHMET ALI TALMAC)

Primary sponsor：

Orthopaedics and taumatology clinic (MD MEHMET ALI TALMAC)

研究实施负责（组长）单位地址：

Halaskargazi caddesi Etfal sk. 34371 Sisli Istanbul Turkey

Primary sponsor's address：

Halaskargazi caddesi Etfal sk. 34371 Sisli Istanbul 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)：

伊斯坦布尔

市(区县)：

Country：

TURKEY

Province：

ISTANBUL

City：

ISTANBUL

单位(医院)：

Sisli Hamidiye Etfal Training and Research hospital

具体地址：

Sisli Hamidiye Etfal Training and Research hospital

Institution
hospital：

Sisli Hamidiye Etfal Training and Research hospital

Address：

Halaskargazi caddesi Etfal sk. 34371 Sisli Istanbul Turkey

经费或物资来源：

we have not any funding

Source(s) of funding：

we have not any funding

研究疾病：

Proximal femoral fracture  

Target disease：

hip fracture

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 回顾性研究 

Study phase：

Retrospective study

研究设计：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

The aim of this study was to compare the clinical and radiological results of long proximal femoral nail antirotation (LPFNA) with proximal femoral locking compression plate (PFLCP) in fixation of reverse oblique fractures.  

Objectives of Study：

The aim of this study was to compare the clinical and radiological results of long proximal femoral nail antirotation (LPFNA) with proximal femoral locking compression plate (PFLCP) in fixation of reverse oblique fractures.

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：

Our exclusion criteria were as follow: age <18 years, AO/OTA 31A1 and 31A2 fractures, fractures that extended 10 cm distal to the level of the lesser trochanter, bilateral hip fracture, pathologic fractures, another fracture in the extremities or spine, open fractures, history of lower limb fracture or deformity, previous ipsilateral lower limb surgery, contralateral hip fracture within the last year, cognitive impairment, severe concomitant medical condition (Grade V American Society of Anesthesiologists [ASA] score) [12]. death during follow-up, reoperation requirements due to mechanical complications, and a follow-up period of <1 year.

Exclusion criteria：

Our exclusion criteria were as follow: age <18 years, AO/OTA 31A1 and 31A2 fractures, fractures that extended 10 cm distal to the level of the lesser trochanter, bilateral hip fracture, pathologic fractures, another fracture in the extremities or spine, open fractures, history of lower limb fracture or deformity, previous ipsilateral lower limb surgery, contralateral hip fracture within the last year, cognitive impairment, severe concomitant medical condition (Grade V American Society of Anesthesiologists [ASA] score) [12]. death during follow-up, reoperation requirements due to mechanical complications, and a follow-up period of <1 year.

研究实施时间：

Study execute time：

从 From 2018-11-25 00:00:00至 To 2019-02-25 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2010-06-25 00:00:00 至 To 2017-06-25 00:00:00

干预措施：

Interventions：

组别：

PROXIMAL FEMORAL NAIL

样本量：

 35

Group：

LPFNA

Sample size：

干预措施：

proximal femoral nailing osteosyntesis

干预措施代码：

Intervention：

proximal femoral nailing osteosynthesis

Intervention code：

组别：

PROXIMAL FEMORAL PLATE OSTEOYNTESIS

样本量：

 27

Group：

PFLCP

Sample size：

干预措施：

proximal femur plate osteosyntesis

干预措施代码：

Intervention：

PLATE FIXATION

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 土耳其

省(直辖市)：

 伊斯坦布尔 

市(区县)：

  

Country：

TURKEY

Province：

Istanbul

City：

ISTANBUL

单位(医院)：

 Sisli Hamidiye Etfal Training and Research hospital 

单位级别：

 三级医院 

Institution
hospital：

SISLI HAMIDIYE ETFAL TRAINING AND RESEARCH HOSPITAL

Level of the institution：

Tertiary Hospital

测量指标：

Outcomes：

指标中文名：

reoperation rates

指标类型：

主要指标

Outcome：

six patients who underwent LPFNA had cut out of the lag screw, one had varus deformity, and one had nonunion; three of those who underwent PFLCP had implant failure with nonunion, while one had nonunion with a deep wound infection.

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

mean operation and fluoroscopy times

指标类型：

主要指标

Outcome：

no statistically significant difference between both groups

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

No

组织：

Sample Name：

No

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

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

No

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

No

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：

No

Blinding：

No

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）：

real time (we upload our data on your system)

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

we have not

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：

Data for this study were collected from patient records, the digital data bank, which included operated patients' information, and outpatient clinic notes

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

Data for this study were collected from patient records, the digital data bank, which included operated patients' information, and outpatient clinic notes

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2020-01-03 08:23:14
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