ChiCTR2200056044 版本V1.2 版本创建时间2023/07/16 23:00:03 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：

ChiCTR2200056044 

最近更新日期：

Date of Last Refreshed on：

2022-09-11 11:41:02 

注册时间：

Date of Registration：

2022-01-31 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Coxa Magna following treatment for developmental dislocation of the hip: Investigation of associated risk factors.

Public title：

Coxa Magna following treatment for developmental dislocation of the hip: Investigation of associated risk factors.

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Coxa Magna following treatment for developmental dislocation of the hip: Investigation of associated risk factors.

Scientific title：

Coxa Magna following treatment for developmental dislocation of the hip: Investigation of associated risk factors.

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：

Ahmet Aslan 

研究负责人：

Ahmet Aslan 

Applicant：

Ahmet Aslan 

Study leader：

Ahmet Aslan 

申请注册联系人电话：

Applicant telephone：

+90 50 56462411

研究负责人电话：

Study leader's telephone：

+90 50 56462411

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：

draaslan@hotmail.com

研究负责人电子邮件：

Study leader's E-mail：

draaslan@hotmail.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：

Alanya Alaaddin Keykubat University

研究负责人通讯地址：

Alanya Alaaddin Keykubat University

Applicant address：

Alanya Alaaddin Keykubat University

Study leader's address：

Alanya Alaaddin Keykubat University

申请注册联系人邮政编码：

Applicant postcode：

07425

研究负责人邮政编码：

Study leader's postcode：

07425

申请人所在单位：

土耳其Alanya Alaaddin Keykubat University

Applicant's institution：

Alanya Alaaddin Keykubat University

研究负责人所在单位：

土耳其Alanya Alaaddin Keykubat University

Affiliation of the Leader：

Alanya Alaaddin Keykubat University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2022/02

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：

Kahramanmara Sütü mam University Medical Research Ethics Committee (TAREK)

Name of the ethic committee：

Kahramanmara Sütü mam University Medical Research Ethics Committee (TAREK)

伦理委员会批准日期：

Date of approved by ethic committee：

2022-01-11 00:00:00

伦理委员会联系人：

Kahramanmara Sütü mam University Medical Research Ethics Committee (TAREK)

Contact Name of the ethic committee：

Kahramanmara Sütü mam University Medical Research Ethics Committee (TAREK)

伦理委员会联系地址：

KSü Tp Fakültesi Dekanl Etik Kurul, Kahramanmara/Turkey

Contact Address of the ethic committee：

KSü Tp Fakültesi Dekanl Etik Kurul, Kahramanmara/Turkey

伦理委员会联系人电话：

Contact phone of the ethic committee：

+90 34 43003424

伦理委员会联系人邮箱：

Contact email of the ethic committee：

tipkaek@ksu.edu.tr

研究实施负责（组长）单位：

None

Primary sponsor：

None

研究实施负责（组长）单位地址：

None

Primary sponsor's address：

None

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

None

Source(s) of funding：

None

Target disease：

Developmental Dysplasia of Hip

Target disease code：

Q65.2

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：

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：

The objective of this study was to determine the frequency of Coxa Magna (CM) following treatment for developmental dislocation of the hip and investigated to risk factors associated with CM.  

Objectives of Study：

The objective of this study was to determine the frequency of Coxa Magna (CM) following treatment for developmental dislocation of the hip and investigated to risk factors associated with CM.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

Methods: Patients who were treated with closed or open reduction with the diagnosis of DDH between January 1997 and December 2017 in the clinics where the authors worked were retrospectively screened. Simple size and Gropus: Considering previous similar studies on the subject; The sample size was determined as at least 34 for each group. The patients were divided into two groups retrospectively according to the treatments applied. Group-1: It consisted of a total of 49 patients who underwent closed reduction and/or closed reduction with extraarticular tenatomy under general anesthesia. Group-2: Open reduction (medial or anterior) and/or open reduction with acetebular osteotomy consisted of a total of 55 patients. Outcome measurement: Femoral head diameters were measured at the last control. The diagnosis of CM was made with a 15% larger size criterion than the healthy side. Diagnosis of avascular necrosis (AVN) Salter et al. placed according to the criteria. AVN classification was done using Kalamchi Mc Ewen criteria. Analyzes: Comparisons will be made between the groups in terms of demographic data, KM and AVN. In addition, KM related factors will be investigated by regression and correlation analysis. Processes: Of the patients who underwent CR or AR between 1997-2017. The last follow-up was completed in December 2021. Evaluation and analysis of the collected data will be done following the approval of the ethics committee and a report will be prepared within 6 months. 

纳入标准：

Patients who were diagnosed with typical DDH radiologically and clinically, had healthy archival records, and were followed up regularly for at least four years were included in the study. In general, regular records of 143 patients were accessed. Of these, 119 patients had at least four years of regular follow-up.

Inclusion criteria

Patients who were diagnosed with typical DDH radiologically and clinically, had healthy archival records, and were followed up regularly for at least four years were included in the study. In general, regular records of 143 patients were accessed. Of these, 119 patients had at least four years of regular follow-up.

排除标准：

Cases who underwent revision surgery were excluded in order to minimize the factors that would affect the results of the study. 15 patients.

Exclusion criteria：

Cases who underwent revision surgery were excluded in order to minimize the factors that would affect the results of the study. 15 patients.

研究实施时间：

Study execute time：

从 From 1997-12-01 00:00:00至 To 2021-12-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2022-01-12 00:00:00 至 To 2022-06-30 00:00:00  

干预措施：

Interventions：

组别：

Group 1

样本量：

49

Group：

Group 1

Sample size：

干预措施：

closed reduction and/or closed reduction with extraarticular tenatomy

干预措施代码：

Intervention：

closed reduction and/or closed reduction with extraarticular tenatomy

Intervention code：

组别：

Group 2

样本量：

55

Group：

Group 2

Sample size：

干预措施：

Open reduction (medial or anterior) and/or open reduction with acetebular osteotomy

干预措施代码：

Intervention：

Open reduction (medial or anterior) and/or open reduction with acetebular osteotomy

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 土耳其

省(直辖市)：

 Kahrmanamaras 

市(区县)：

 Kahrmanamaras 

Country：

Turkey 

Province：

Kahrmanamaras 

City：

Kahrmanamaras 

单位(医院)：

Sutcu Imam Universty Hospital 

单位级别：

Tertiary A 

Institution
hospital：

Sutcu Imam Universty Hospital

Level of the institution：

Tertiary A

国家：

 土耳其

省(直辖市)：

 Antalya 

市(区县)：

 Antalya 

Country：

Turkey 

Province：

Antalya 

City：

Alanya 

单位(医院)：

Alanya Educcation and Research Hospital 

单位级别：

Tertiary A 

Institution
hospital：

Alanya Educcation and Research Hospital

Level of the institution：

Tertiary A

国家：

 土耳其

省(直辖市)：

 Isparta 

市(区县)：

 Isparta 

Country：

Turkey 

Province：

Isparta 

City：

Isparta 

单位(医院)：

Suleyman Demirel University Hospital 

单位级别：

Tertiary 

Institution
hospital：

Suleyman Demirel University Hospital

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

Frequency of Coxa Magna and Avascular necrosis

指标类型：

主要指标

Outcome：

Frequency of Coxa Magna and Avascular necrosis

Type：

Primary indicator

测量时间点：

at least four years after treatment

测量方法：

Measurement of femoral head diameters at the last control; It was performed with the method described by Mose et al. And also, According to the definition by Gamble et al, it was decided with the criterion of 15% greater size than the healthy side for CM. On the other hand, the diagnosis of&

Measure time point of outcome：

at least four years after treatment

Measure method：

Measurement of femoral head diameters at the last control; It was performed with the method described by Mose et al. And also, According to the definition by Gamble et al, it was decided with the criterion of 15% greater size than the healthy side for CM. On the other hand, the diagnosis of&

指标中文名：

Risk factors associated with CM

指标类型：

次要指标

Outcome：

Risk factors associated with CM

Type：

Secondary indicator

测量时间点：

at least four years after treatment

测量方法：

Correlation and regression analyzes will be performed to investigate the relationship between demographic, clinical, radiological parameters and CM.

Measure time point of outcome：

at least four years after treatment

Measure method：

Correlation and regression analyzes will be performed to investigate the relationship between demographic, clinical, radiological parameters and CM.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织：

Sample Name：

N/A

Tissue：

N/A

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

N/A

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

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

Divided into two groups according to treatment methods. Without any randomisation.

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

Divided into two groups according to treatment methods. Without any randomisation.

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：

None

Blinding：

None

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

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）：

None

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

None

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：

None

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

None

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2022-01-31 05:24:26