ChiCTR2000034005 版本V1.1 版本创建时间2020/06/21 07:14:16 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2000034005 

最近更新日期：

Date of Last Refreshed on：

 2020-06-21 07:12:20 

注册时间：

Date of Registration：

 2020-06-21 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Efficacy of a surgical technique in the distal nail embedding with bone overgrowth of the distal phalange

Public title：

Efficacy of a surgical technique in the distal nail embedding with bone overgrowth of the distal phalange

注册题目简写：

English Acronym：

Efficacy of a surgical technique in the distal nail embedding with bone overgrowth of the distal phalange

研究课题的正式科学名称：

Efficacy of a surgical technique in the distal nail embedding with bone overgrowth of the distal phalange

Scientific title：

Efficacy of a surgical technique in the distal nail embedding with bone overgrowth of the distal phalange

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：

Mikolaj Dabrowski 

研究负责人：

Mikolaj Dabrowski 

Applicant：

Mikolaj Dabrowski 

Study leader：

Mikolaj Dabrowski 

申请注册联系人电话：

Applicant telephone：

 +48604514716

研究负责人电话：

Study leader's
telephone：

+48604514716

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：

 mdabrowski@ump.edu.pl

研究负责人电子邮件：

Study leader's E-mail：

 mdabrowski@ump.edu.pl

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：

Department of Spine Orthopedics and Biomechanics, 28 June 1956 Street 135/147 Poznan

研究负责人通讯地址：

28 June 1956 Street 135/147 61-545 Poznan

Applicant address：

Department of Spine Orthopedics and Biomechanics, 28 June 1956 Street 135/147 Poznan

Study leader's address：

28 June 1956 Street 135/147 61-545 Poznan

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：

波兰波茲兰医科大学

Applicant's institution：

Poznan University of Medical Sciences

研究负责人所在单位：

波兰波茲兰医科大学

Affiliation of the Leader：

Poznan University of Medical Sciences

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：

 33/20

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：

Bioethics Committee at Poznan University of Medical Sciences

Name of the ethic committee：

Bioethics Committee at Poznan University of Medical Sciences

伦理委员会批准日期：

Date of approved by ethic committee：

 2020-01-16 00:00:00

伦理委员会联系人：

bioetyka.ump@ump.edu.pl

Contact Name of the ethic committee：

Bioethics Committee at Poznan University of Medical Sciences

伦理委员会联系地址：

Centrum Stomatologii ul. Bukowska 70, pok A204 60-812 Poznań

Contact Address of the ethic committee：

Centrum Stomatologii ul. Bukowska 70, pok A204 60-812 Poznań

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：

Poznan University of Medical Sciences

Primary sponsor：

Poznan University of Medical Sciences

研究实施负责（组长）单位地址：

Department of Spine Orthopedics and Biomechanics, 28 June 1956 Street 135/147 Poznan

Primary sponsor's address：

Department of Spine Orthopedics and Biomechanics, 28 June 1956 Street 135/147 Poznan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

NA

Source(s) of funding：

NA

研究疾病：

nail disorders  

Target disease：

young and adults with nail disorders

研究疾病代码：

Target disease code：

研究类型：

卫生服务研究

Study type：

Health services reaserch

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

历史对照研究 

Study design：

Historical control 

研究目的：

Distal nail embedding due to hyponychium hypertrophy can be caused by traumatic or surgical avulsion of the nail. As a consequence of these changes, the nail plate is blocked through the deformed tip of the toe. Changes that occur at the tip of the big toe are due to bone growth on the dorsal surface of the distal end of the distal phalanx. To present a surgical technique for the treatment of hypertrophy of the tip of the toe and evaluate its effectiveness.  

Objectives of Study：

The surgical technique involved remodeling of the tip of the big toe, with removal of the hypertrophied bone of the distal phalange. The procedure was assessed by using a questionnaire. A total of 85% of respondents were satisfied with the procedure. Nearly 80% of patients rated the cosmetic effect as good or very good. The technique was an effective treatment and increased the quality of life of those with disorders of nail growth associated with hypertrophy of the tip and hyponychium, with bone overgrowth.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

A total of 108 distal embedded nails with bone spurs were operated on in 76 patients between 2016 and 2018. All surgeries were performed at the Anmedica-Healthy Foot Center, Grunwaldzka Street 121, Poznań, Poland. Two doctors performed all the operations.

Inclusion criteria

Before surgery, patients underwent diagnostic imaging in the form of palpable/anteroposterior (AP) and lateral foot views (Figures 2). In the case of clinical doubt, a pre-operative ultrasound examination of the big toe was performed (Figure 3). The average follow-up time was 1.5 years.

排除标准：

NA

Exclusion criteria：

NA

研究实施时间：

Study execute time：

从 From 2017-01-01 00:00:00至 To 2019-05-27 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2017-01-01 00:00:00 至 To 2018-12-31 00:00:00

干预措施：

Interventions：

组别：

Case series

样本量：

 108

Group：

Case series

Sample size：

干预措施：

nail surgery

干预措施代码：

Intervention：

nail surgery

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 波兰

省(直辖市)：

 维尔科玻什卡 

市(区县)：

  

Country：

Poland

Province：

wielkopolska

City：

单位(医院)：

 Poznan University of Medical Sciences 

单位级别：

  

Institution
hospital：

Poznan University of Medical Sciences

Level of the institution：

测量指标：

Outcomes：

指标中文名：

We present a surgical technique and assess its effectiveness in the treatment of hypertrophy of the tip of the toe, caused by earlier injury, microdamage, or removal of the nail plate

指标类型：

次要指标

Outcome：

We present a surgical technique and assess its effectiveness in the treatment of hypertrophy of the tip of the toe, caused by earlier injury, microdamage, or removal of the nail plate

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：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 16 岁 years
最大 Max age 69 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）：

NA

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

NA

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：

Blinding：

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）：

https://forms.gle/ZLr3HcQLTtnorxeG7

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

https://forms.gle/ZLr3HcQLTtnorxeG7

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：

https://forms.gle/ZLr3HcQLTtnorxeG7

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

https://forms.gle/ZLr3HcQLTtnorxeG7

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2020-06-21 07:10:27