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急性跟腱断裂修复
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注册号:

Registration number:

ChiCTR2000035229 

最近更新日期:

Date of Last Refreshed on:

2020-08-04 

注册时间:

Date of Registration:

2020-08-04 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

急性跟腱断裂修复 

Public title:

Repair for acute Achilles tendon rupture 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

改良Bunnell修复与束束缝合的对比性研究 

Scientific title:

Modified Bunnell suture repair versus bundle-to-bundle suture repair for acute Achilles tendon rupture 

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:

王晓猛 

研究负责人:

王晓猛 

Applicant:

Xiaomeng Wang 

Study leader:

Xiaomeng Wang 

申请注册联系人电话:

Applicant telephone:

+86 18633835079 

研究负责人电话:

Study leader's telephone:

+86 18633835079 

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:

nickwang07@163.com 

研究负责人电子邮件:

Study leader's E-mail:

nickwang07@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:

河北省石家庄市桥西区自强路139号 

研究负责人通讯地址:

河北省石家庄市桥西区自强路139号 

Applicant address:

139 Ziqiang Road, Shijiazhuang, Hebei, China 

Study leader's address:

139 Ziqiang Road, Shijiazhuang, Hebei, China 

申请注册联系人邮政编码:

Applicant postcode:

050051 

研究负责人邮政编码:

Study leader's postcode:

050051 

申请人所在单位:

河北医科大学第三医院 

Applicant's institution:

Hebei Medical University Third Affiliated 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:

S2020-001-1 

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:

河北医科大学第三医院伦理委员会 

Name of the ethic committee:

Ethics Committee of the Third Hospital of Hebei Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-03-12 

伦理委员会联系人:

郑金 

Contact Name of the ethic committee:

Jin Zheng 

伦理委员会联系地址:

河北省石家庄市桥西区自强路139号 

Contact Address of the ethic committee:

139 Ziqiang Road, Shijiazhuang, Hebei, China 

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:

河北医科大学第三医院 

Primary sponsor:

Hebei Medical University Third Affiliated Hospital 

研究实施负责(组长)单位地址:

河北省石家庄市桥西区自强路139号 

Primary sponsor's address:

139 Ziqiang Road, Shijiazhuang, Hebei, 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):

河北

市(区县):

石家庄

Country:

China

Province:

Hebei

City:

Shijiazhaung

单位(医院):

河北医科大学第三医院

具体地址:

河北省石家庄市桥西区自强路139号

Institution
hospital:

Hebei Medical University Third Affiliated Hospital

Address:

139 Ziqiang Road

经费或物资来源:

自筹 

Source(s) of funding:

self-financing 

研究疾病:

跟腱断裂 

Target disease:

Achilles tendon rupture 

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:

探索性研究/预试验 

Study phase:

研究目的:

本研究目的:比较经皮修复(改良 Bunnell缝合技术)和开放修复(束束缝合技术)治疗急性跟腱断裂的手术效果。 

Objectives of Study:

This study aimed to compare the operative outcome of percutaneous repair (modified Bunnell suture technique) versus open repair (bundle-to-bundle suture technique) of acute Achilles tendon rupture. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

半随机对照 

Study design:

Quasi-randomized controlled 

纳入标准:

(1)年龄18 ~ 45岁; (2)体质指数(BMI) <34 kg/m2; (3)闭合性损伤; (4)急性跟腱断裂(<跟腱断裂后7天)。 

Inclusion criteria

(1) aged 18 to 45 years; (2) body mass index (BMI) <34 kg/m2; (3) closed injury; (4) acute Achilles tendon rupture (<7 days since tendon rupture).  

排除标准:

(1)部分跟腱断裂(MRI诊断或通过术中探查); (2)跟腱断裂距离跟腱止点小于2厘米; (3)可能影响功能测试结果的疾病,如自身免疫性疾病、深静脉血栓形成或神经病变。 

Exclusion criteria:

(1) partial Achilles tendon rupture (diagnosed on MRI or via intraoperative probing); (2) Achilles tendon ruptured at a distance of less than 2 cm from the tendon insertion point; (3) diseases that may affect the results of the functional tests, such as autoimmune disease, deep vein thrombosis, or neuropathy. 

研究实施时间:

Study execute time:

From2016-05-01To 2018-01-01 

征募观察对象时间:

Recruiting time:

From2016-05-01To 2018-01-01 

干预措施:

Interventions:

组别:

A

样本量:

32

Group:

A

Sample size:

干预措施:

束束缝合

干预措施代码:

Intervention:

bundle-to-bundle suture

Intervention code:

组别:

B

样本量:

32

Group:

B

Sample size:

干预措施:

改良Bunnell缝合

干预措施代码:

Intervention:

modified Bunnell suture

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

河北省 

市(区县):

石家庄 

Country:

China 

Province:

Hebei 

City:

Shijiazhuang 

单位(医院):

河北医科大学第三医院 

单位级别:

三级甲等医院 

Institution
hospital:

Hebei Medical University Third Affiliated Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

跟腱完全断裂评分

指标类型:

主要指标 

Outcome:

Achilles tendon total rupture 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:

美国足踝协会后足评分

指标类型:

主要指标 

Outcome:

American Orthopaedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale 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:

可视化疼痛评分

指标类型:

主要指标 

Outcome:

visual analog scale (VAS) pain score

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:

组织:

Sample Name:

No

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 45 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):

根据入院时奇偶数顺序分组。

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

The operative technique was selected by assigning each patient an odd or even number in accordance with the order of hospital admission.

盲法:

No

Blinding:

No

试验完成后的统计结果(上传文件):

点击下载

Calculated Results after
the Study Completed(upload file):

download

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):

发表文章

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

Published papers

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:

采用SPSS数据库和Excel、word 保存数据。

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

Microsoft office excel, word and SPSS software was used to conserving data.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2020-08-04
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