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双钢板和更换髓内钉联合附加钢板治疗股骨复杂性骨不连的临床对照研究
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注册号:

Registration number:

ChiCTR-ORC-17014062 

最近更新日期:

Date of Last Refreshed on:

2017-12-20 

注册时间:

Date of Registration:

2017-12-20 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

双钢板和更换髓内钉联合附加钢板治疗股骨复杂性骨不连的临床对照研究 

Public title:

The Clinical Results of Dual Plate versus Exchange Nailing with Augmentation Plating for Complicated Femoral Shaft Nonunion. 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

双钢板和更换髓内钉联合附加钢板治疗股骨复杂性骨不连的临床对照研究 

Scientific title:

The Clinical Results of Dual Plate versus Exchange Nailing with Augmentation Plating for Complicated Femoral Shaft Nonunion.  

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:

张伟 

研究负责人:

唐佩福 

Applicant:

Wei Zhang 

Study leader:

Peifu Tang 

申请注册联系人电话:

Applicant telephone:

+86 15210011027 

研究负责人电话:

Study leader's telephone:

+86 13801379901 

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:

zwtyrran@163.com 

研究负责人电子邮件:

Study leader's E-mail:

pftang301@163.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:

北京市海淀区复兴路28号解放军总医院骨科一病区  

研究负责人通讯地址:

北京市海淀区复兴路28号解放军总医院骨科一病区  

Applicant address:

Orthopedics department, 28 Fuxing Road, Haidian District, Beijing, China 

Study leader's address:

Orthopedics department, 28 Fuxing Road, Haidian District, Beijing, China 

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:

中国人民解放军总医院骨科 

Applicant's institution:

Orthopedics department,General Hosiptal of PLA 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

中国人民解放军总医院 

Primary sponsor:

General Hospital of PLA  

研究实施负责(组长)单位地址:

北京市海淀区复兴路28号解放军总医院骨科一病区  

Primary sponsor's address:

Orthopedics department, 28 Fuxing Road, Haidian District, Beijing, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京市

市(区县):

海淀区

Country:

China

Province:

Beijing

City:

Haidian

单位(医院):

中国人民解放军总医院

具体地址:

北京市海淀区复兴路28号解放军总医院骨科一病区

Institution
hospital:

General Hospital of PLA

Address:

Orthopedics department, 28 Fuxing Road, Haidian District, Beijing, China

经费或物资来源:

自筹 

Source(s) of funding:

Self-financing 

研究疾病:

股骨干骨折术后复杂性骨不连 

Target disease:

complicated femoral shaft nonunion after surgery 

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 

研究目的:

比较双钢板和更换髓内钉联合附加钢板治疗复杂性股骨干骨不连的临床预后 

Objectives of Study:

To evaluate the clinical results of dual plating versus exhange nailing with augmentation plating for complicated femoral shaft nonunion 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

下列所有标准必须同时满足才能入组本研究: 1.骨折不愈合:根据美国FDA(1988)定义,骨折9个月未愈合,并且没有进一步愈合倾向已经有3个月。 2.股骨干的定义:根据OTA定义,股骨干是指近端位于股骨小转子下水平以远,远端股骨髁间宽度为边长的正方形区域以近的部分。 3.无菌性骨不连:术前血清学检查阴性,术前局部查体检查阴性,术后断端组织细菌学培养阴性。 4. 患者年龄大于18岁。 在以上条件都满足的基础上,满足以下条件之一患者最终纳入研究: 1.股骨干骨折钢板或髓内钉术后,且原有内植物失效(钢板或髓内钉主钉断裂)。 2.明显畸形:内翻大于5°;或 短缩>2cm;或 旋转>15°。 3.2cm<骨缺损<6cm。 

Inclusion criteria

All of the following criteria must be met at the same time to enter the study: 1. The definition of the nonunion is that: patients whose fracture did not heal for at least 9 months since the fixation of the fracture and whose continuous imaging observations in the recent 3 months did not show any progress in fracture healing; 2. According to OTA classification, the definition of the femoral shaft is that: the transverse lower edge of the lesser trochanter to the upper border of the transepicondylar width of the knee; 3. aseptic nonunion:negative inflammatory markers and physical examination preoperatively and negative bacterial culture postoperatively; 4. aged older than 18 years; On the basis of all the above conditions, one of the following conditions is finally included in the study: 1. primary interanl device is broked after plating or nailing; 2. obvious nalformation: angulation >5 degree, or malrotation > 15 degree, or LLD (limb length discrepancy) > 2 cm; 3. bone defect 2 to 6cm. 

排除标准:

1.感染性骨不连。 2.病理性骨折术后骨不连。 3.骨缺损>6cm或<2cm。 4.不伴明显畸形:内翻<5°,旋转畸形<15°,短缩畸形<2cm。 5.有精神疾病等、预期会导致依从性不良的患者 6.患者拒绝参加本研究者 

Exclusion criteria:

1. septic nonunion; 2. Pathological fracture nonunion; 3. without significant malformation which was defined as angulation <5°,malrotation < 15° LLD (limb length discrepancy) < 2 cm; 4. Poor compliance. 5. refuse to participate in the study.  

研究实施时间:

Study execute time:

From2018-01-01To 2018-12-31 

干预措施:

Interventions:

组别:

试验组

样本量:

20

Group:

Experimental group

Sample size:

干预措施:

更换髓内钉联合附加钢板

干预措施代码:

Intervention:

exchange nailing with augmentation plating

Intervention code:

组别:

对照组

样本量:

20

Group:

control group

Sample size:

干预措施:

双钢板

干预措施代码:

Intervention:

dual plating

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京市 

市(区县):

海淀区 

Country:

China 

Province:

Beijing 

City:

Haidian 

单位(医院):

中国人民解放军总医院 

单位级别:

三级甲等 

Institution
hospital:

General Hospital of PLA  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

骨折愈合时间

指标类型:

主要指标 

Outcome:

Fracture healing time

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

骨折愈合率

指标类型:

主要指标 

Outcome:

rate of fracture healing

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SF-36评分量表

指标类型:

主要指标 

Outcome:

SF-36 score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

手术时间

指标类型:

次要指标 

Outcome:

operation time

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

切口长度

指标类型:

次要指标 

Outcome:

length of incision

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

出血量

指标类型:

次要指标 

Outcome:

blood loss

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

输血量

指标类型:

次要指标 

Outcome:

blood transfusion

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

膝关节活动范围

指标类型:

次要指标 

Outcome:

knee range of motion

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

开始负重时间

指标类型:

次要指标 

Outcome:

start time of weight bearing

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

完全负重时间

指标类型:

次要指标 

Outcome:

time of fully weight bearing

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

软组织感染

指标类型:

副作用指标 

Outcome:

soft tissue infection

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

骨感染

指标类型:

副作用指标 

Outcome:

bone infection

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

神经血管损伤

指标类型:

副作用指标 

Outcome:

neuro-vascular injury

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

重返工作时间

指标类型:

次要指标 

Outcome:

Time to return to work

Type:

Secondary 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:

骨不连断端组织

组织:

Sample Name:

tissue of nonunion site

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

未使用

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

no application

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

2018年12月,中国人民解放军总医院

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

December, 2018, General Hosiptal of PLA

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:

病例记录表

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

casse record form

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2017-12-20
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