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请与我们联系上传伦理批件 改良线袢法Latarjet骨块微动产生机制:基于CT的有限元分析
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注册号:

Registration number:

ChiCTR2000039954 

最近更新日期:

Date of Last Refreshed on:

2020-11-15 

注册时间:

Date of Registration:

2020-11-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

请与我们联系上传伦理批件 改良线袢法Latarjet骨块微动产生机制:基于CT的有限元分析 

Public title:

Bone mass after modified suture-button Latarjet micro-movement generation: CT-based finite element analysis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

改良线袢法Latarjet骨块微动产生机制:基于CT的有限元分析 

Scientific title:

Bone mass after modified suture-button Latarjet micro-movement generation: CT-based finite element analysis 

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:

梁新枝 

研究负责人:

柳海峰 

Applicant:

Liang Xinzhi 

Study leader:

Liu Haifeng 

申请注册联系人电话:

Applicant telephone:

13713899307 

研究负责人电话:

Study leader's telephone:

13713899307 

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:

kenliangxz@163.com 

研究负责人电子邮件:

Study leader's E-mail:

819811255@qq.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:

广东省深圳市福田区笋岗西路3002号 

研究负责人通讯地址:

广东省深圳市福田区笋岗西路3002号 

Applicant address:

No. 3002 Sungang West Road, Futian District, Shenzhen, Guangdong Province 

Study leader's address:

No. 3002 Sungang West Road, Futian District, Shenzhen, Guangdong Province 

申请注册联系人邮政编码:

Applicant postcode:

518035 

研究负责人邮政编码:

Study leader's postcode:

518035 

申请人所在单位:

深圳大学第一附属医院(深圳市第二人民医院) 

Applicant's institution:

The First Affiliated Hospital of Shenzhen University (Shenzhen Second People's 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:

20200601012-FS01 

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:

深圳市第二人民医院临床科研伦理委员会 

Name of the ethic committee:

Shenzhen Second People's Hospital Clinical Research Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

陈昶烨 

Contact Name of the ethic committee:

Chen Changye 

伦理委员会联系地址:

广东省深圳市福田区笋岗西路3002号深圳市第二人民医院科教科(临床研究管理中心) 

Contact Address of the ethic committee:

Department of Science and Education (Clinical Research Management Center), The Second People's Hospital of Shenzhen, 3002 Xianggang West Road, Futian District, Shenzhen, Guangdong Province, 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:

深圳大学第一附属医院(深圳市第二人民医院) 

Primary sponsor:

The First Affiliated Hospital of Shenzhen University (Shenzhen Second People's Hospital) 

研究实施负责(组长)单位地址:

广东省深圳市福田区笋岗西路3002号 

Primary sponsor's address:

No. 3002 Sungang West Road, Futian District, Shenzhen, Guangdong Province 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东省

市(区县):

深圳市

Country:

China

Province:

Guangdong Province

City:

Shenzhen

单位(医院):

深圳大学第一附属医院(深圳市第二人民医院)

具体地址:

广东省深圳市福田区笋岗西路3002号

Institution
hospital:

The First Affiliated Hospital of Shenzhen University (Shenzhen Second People's Hospital)

Address:

No. 3002 Sungang West Road, Futian District, Shenzhen, Guangdong Province

经费或物资来源:

院内临床研究项目资金 

Source(s) of funding:

In-hospital clinical research project funds 

研究疾病:

肩关节脱位 

Target disease:

shoulder dislocation 

研究疾病代码:

 

Target disease code:

 

研究类型:

基础科学研究 

Study type:

Basic Science 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

1)获得有利于有限元建模的可靠CT数据,需明确拍片体位及扫描方法技巧,一方面为了建模,另一方面有利于临床医生阅片发现潜在临床疾病。 2)各时期移植骨块与关节盂连接方式不同,相应骨块塑性机制不同,需明确以上不同时期骨块受力、位移情况,并结合wolff定律和既往随访病人影像数据结合分析以明确塑性机制。 3)由于力的作用是相互的,肱骨外旋过程也会受到骨块及肩胛骨的反作用力,但由于该术式为弹性固定,存在韧性缓冲,既往4年随访结果并未发现肱骨退行性变,本次课题探讨希望进一步剖析延缓肱骨退变的可能机制。 4) 根据术前与术后最终塑性时肩关节功能评分(包括ASES评分及Constant-Murley评分)、术前术后双侧外旋外展具体活动度、术后4年发生肩关节退行性变、骨块溶解、碎裂、非梨形关节盂塑性发生率,证明该改良术式Latarjet除具有良好微观塑性的结局,同样也具有良好宏观的临床结局三、研究概况。 

Objectives of Study:

(1) To obtain reliable CT data for finite element models. It is necessary to clarify the technique of radiography position and scanning method, which on the one hand is for modeling, and on the other hand is helpful for clinicians to read the films to find potential clinical diseases. (2) The connection between bone graft and articular glenoid is different in different periods which caused bone mass remodelinng differently, so it is necessary to clarify the above different periods of bone force and displacement, and combine the analysis of wolff's law and previous follow-up patient image data to clarify the plasticity mechanism. 3) Since the forces are mutual, the external rotation of the humerus will also be affected by the reaction forces of the bone and the scapular. However,because the procedure is an elastic fixation, there is a toughness cushion.Since no degenerative changes of the humerus have been observed in the past 4 years, the present study aims to further analyze the possible mechanisms that delay the degeneration of the humerus. 4)Based on the preoperative and postoperative shoulder function scores (including ASES score and Constant-Murley score) at the time of final plasticity, the preoperative and postoperative bilateral external rotation and abduction activities, and the incidence of degenerative shoulder changes, osteolysis, fragmentation, and non-pyramidal glenoid plasticity at 4 years after surgery, the modified Latarjet has not only good microplasticity, but also good macroscopic clinical outcomes. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

历史对照研究 

Study design:

Historical control 

纳入标准:

1)年龄>25岁; 2)CT影像扫描清晰 3)随访满意,且随访时间三年或以上 4)无复发性脱位或骨块吸收消失 5)获得患者知情同意。 

Inclusion criteria

1)Age >25 years. 2)Clear CT scan 3)Satisfactory follow-up and three or more years of follow-up 4)No recurrent dislocation or loss of bone mass resorption 5)Obtain informed consent from patients. 

排除标准:

1)影像数据模糊难以建模 2)随访时间不足 3)合并肩关节其他疾病,如冻结肩等 4)翻修患者 

Exclusion criteria:

1) Blurred image data is difficult to model 2) Insufficient follow-up time 3) Complication of other shoulder joint conditions, such as frozen shoulder. 4) Revisiom of patients 

研究实施时间:

Study execute time:

From2020-11-30To 2022-05-31 

征募观察对象时间:

Recruiting time:

From2020-12-01To 2021-01-31 

干预措施:

Interventions:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

深圳市 

Country:

China 

Province:

Guangdong Province 

City:

Shenzhen City 

单位(医院):

深圳大学第一附属医院(深圳市第二人民医院) 

单位级别:

市级 

Institution
hospital:

The First Affiliated Hospital of Shenzhen University (Shenzhen Second People's Hospital)  

Level of the institution:

municipalities 

测量指标:

Outcomes:

指标中文名:

ASES评分

指标类型:

主要指标 

Outcome:

ASES 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:

Constant-Murley评分

指标类型:

主要指标 

Outcome:

Constant-Murley 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:

肩关节活动度

指标类型:

主要指标 

Outcome:

Range of Motion of Shoulder joint

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后并发症

指标类型:

主要指标 

Outcome:

postopreative complications

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

骨块塑形相关指标

指标类型:

主要指标 

Outcome:

relative data of bone mass remodeling

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肱骨应力大小

指标类型:

次要指标 

Outcome:

Magnitude of stress of humerus

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肱骨应力分布

指标类型:

次要指标 

Outcome:

Distribution of stress of humerus

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:

正在进行

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):

由两名高年资运动医学医生对既往病人影像学数据进行回顾分析 样本含量估计 抽样样本量: n: 为样本量; P×(1-P):方差,抽样个体值和整体均值之间的偏离程度,抽样数值分布越分散方差越大,需要的采样量越多; △:为抽样误差(可以根据均值的百分比设定),由于是倒数平方关系,抽样误差减小为1/2,抽样量需要增加为4倍; Zα/2: 为可靠性系数,即置信度,置信度为95%时,=1.96 根据实际情况,该术式术后非正梨形关节盂外形比例约为10%左右,以及术后骨块位移误差约在10%,代入公式N=Zα/2 2×P×(1-P)/△,此时P=0.05,△=0.1, Zα/2 =1.96 N=1.96×1.96×0.1×(1-0.1)/(0.1×0.1)≈49

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

Retrospective analysis of previous patient imaging data by two senior sports medicine physicians Sample content estimates Sample size. n: is the sample size. P x (1 - P): variance, the degree of deviation between the individual values of the sample and the overall mean, the greater the spread of the s

盲法:

Blinding:

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):

原始数据将在试验完成后6个月内公开,可根据申请人邮箱获得相关原始数据。

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

The raw data will be made publicly available within 6 months of completion of the trial and can be obtained from the applicant's email address.

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:

数据采集为CT数据,由dicon格式输出

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

Data acquisition as CT data, output from dicon format

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-11-15
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