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中国个性化全颞下颌关节的前瞻性病例系列报告
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注册号:

Registration number:

ChiCTR-ONC-16009712 

最近更新日期:

Date of Last Refreshed on:

2016-11-02 

注册时间:

Date of Registration:

2016-11-02 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中国个性化全颞下颌关节的前瞻性病例系列报告 

Public title:

Prospective reports on Chinese customized total temporomandibular joint prosthesis reconstruction cases 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中国个性化全颞下颌关节的前瞻性病例系列报告 

Scientific title:

Prospective reports on Chinese customized total temporomandibular joint prosthesis reconstruction cases 

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:

张善勇 

研究负责人:

张善勇 

Applicant:

Shanyong Zhang 

Study leader:

Shanyong Zhang 

申请注册联系人电话:

Applicant telephone:

+86 13817673406 

研究负责人电话:

Study leader's telephone:

+86 13817673406 

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:

zhangshanyong@126.com 

研究负责人电子邮件:

Study leader's E-mail:

zhangshanyong@126.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:

上海市制造局路639号 

研究负责人通讯地址:

上海市黄浦区制造局路639号上海交通大学附属第九人民医院1号楼13楼医生办公室 

Applicant address:

639 Zhizaoju Road, Shanghai  

Study leader's address:

639 Zhizaoju Road, Shanghai 

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:

上海交通大学附属第九人民医院口腔颌面外科 

Applicant's institution:

The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine.Department of Oral and Maxillofacial Surgery 

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:

2015-18 

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:

上海交通大学医学院附属第九人民医院伦理委员会  

Name of the ethic committee:

Ethics Committee of Shanghai Ninth People's Hospital Affliated to Shanghai Jiaotong University School of Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2015-04-22 

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:

上海交通大学附属第九人民医院 

Primary sponsor:

Shanghai 9th People's Hospital, Affiliate to Shanghaijiaotng University School of Medicine  

研究实施负责(组长)单位地址:

上海市黄浦区制造局路639号上海交通大学附属第九人民医院1号楼13楼医生办公室 

Primary sponsor's address:

639 Zhizaoju Road, Shanghai 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海市

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海交通大学附属第九人民医院

具体地址:

上海市黄浦区制造局路639号上海交通大学附属第九人民医院1号楼13楼医生办公室

Institution
hospital:

Shanghai Ninth Peoples's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Address:

639 Zhizaoju Road, Shanghai

经费或物资来源:

2015年高峰高原计划、2015年医工交叉重点项目、2016年上海市科委项目、2016年科技部子项目、2016年市卫生局项目、2016年临助项目 

Source(s) of funding:

Science & Technology Commission Project of Shanghai (2016), Peak plateau Project (2015), Medical-Engineering Cross Project (2015), Promotion plan on clinical research (2016) 

研究疾病:

颞下颌关节骨关节病 

Target disease:

Temporomandibular joint bone disease 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

通过临床试验评价自主研发的个性化全颞下颌关节假体植入的有效性和安全性 

Objectives of Study:

To evaluate the clinical efficacy and safety of customized total temporomandibular joint implants in the operation of TMJ reconstruction. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

1)受试者年龄在40-75岁(含),性别不限 2)造成颅底穿孔关节良性肿瘤或类肿瘤,或涉及到关节的下颌骨良性病变等 3)3个月内未参加其他临床验证者 4)无急性感染性疾病、精神病、系统性疾病 5)自愿受试并签署知情同意书  

Inclusion criteria

1. Aged 40 to 75 years; 2). Benign tumors or other masses of TMJ which cause perforation of skull base,or mandibular benign lesion which affect TMJ; 3. Did not participate in any clinical trials in the last three monthes; 4. Without acute infectious diseases,mental diseases,system disease; 5. Agree and signed the informed consent. 

排除标准:

1)对钛合金内植物过敏的患者 2)急性或严重感染或慢性感染处于急性发作期的患者 3)手术导致大范围软组织缺损,术后创口没有足够软组织覆盖的患者 4)放射性骨髓炎、急慢性骨髓炎、骨质疏松患者 5)合并心、肺、脑、肾等重要脏器原发性疾病未控制的患者 6)精神疾病患者 7)妊娠、哺乳期女性 8)无法配合治疗的患者 9)中晚期恶性肿瘤、肿瘤远处转移、肿瘤复发患者 10)病情危重,难以对假体的有效性和安全性做出确切评价的患者 

Exclusion criteria:

1. Allegic to titanium alloy implants; 2. Acute or serious infection,or acute attack of chronic infection; 3. A large range of soft issue defects without enough soft issue cover after operation; 4. Radioactive osteomyelitis,acute or chronic osteomyelitis,Osteoporosis; 5. With heart,lung,brain,kidney and other important organs diseases uncontrolled; 6. With mental diseases; 7. Pregnant or lactating woman; 8. With non-compliant; 9. Malignant tumor in middle and advanced stage,tumor distant metastasis or recurrent; 10. Patient is in a critical condition and hard to evaluate its efficacy and safety. 

研究实施时间:

Study execute time:

From2016-11-01To 2018-10-01 

征募观察对象时间:

Recruiting time:

From2016-11-01To 2018-10-01 

干预措施:

Interventions:

组别:

case series

样本量:

6

Group:

case series

Sample size:

干预措施:

中国个性化全颞下颌关节假体

干预措施代码:

Intervention:

Chinese customized total temporomandibular joint prosthesis

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海市 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海交通大学附属上海第九人民医院 

单位级别:

三甲 

Institution
hospital:

The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

疼痛

指标类型:

主要指标 

Outcome:

Pain

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

开口度

指标类型:

主要指标 

Outcome:

Mouth Openning

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

开口型

指标类型:

次要指标 

Outcome:

Style of mouth openning

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

咬合力

指标类型:

次要指标 

Outcome:

Occlusal force

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

咬合关系

指标类型:

次要指标 

Outcome:

Occlusal relationship

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

侧方前伸运动

指标类型:

次要指标 

Outcome:

Lateral and protrusive movement

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

颌面形态

指标类型:

次要指标 

Outcome:

Cranio facial morphology

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

手术效率

指标类型:

次要指标 

Outcome:

Operation efficiency

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量量表

指标类型:

次要指标 

Outcome:

Quality of life scale

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良事件发生率

指标类型:

附加指标 

Outcome:

Adverse events rate

Type:

Additional 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 40 years
最大 Max age 75 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):

聘请统计学专员,通过随机数生成软件计算产生随机序列。

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

Statistics specialists generates the random number sequence by random number generation software.

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:

即时公开/Real time access

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):

2018.12.1后可通过电子邮件、现场资料查询等方式公开原始数据

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

The original data can be disclosed by e-mail, on-site data inquiry, etc. after 2018.12.1.

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:

本研究过程中,将由申办者指派的临床监查员定期对研究医院进行现场监查访问,以保证研究方案的所有内容都得到严格遵守和填写研究资料的正确。参加研究人员必须经过统一培训,统一记录方式与判断标准。整个临床试验过程均应在严格操作下进行。研究者应按病例报告表填写要求,如实、详细、认真记录CRF中各项内容,以确保病例报告表内容完整真实、可靠。临床试验中所有观察结果和发现都应加以核实,以保证数据的可靠性,确保临床试验中各项结论来源于原始数据。在临床试验和数据处理阶段均有相应的数据管理措施。研究者应认真填写所有研究资料,包括对所有参加受试者的确认(能有效地核对不同的记录资料,如CRF和医院原始记录)、所有原始的有签名的患者知情同意书、所有CRF、药品分发的详细记录等。试验结束后所有临床研究资料交药理机构办公室保存。

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

During the course of the study, the clinical investigators assigned by the sponsor will conduct on-site surveillance visits to the research hospitals on a regular basis to ensure that all elements of the study protocol are strictly adhered to and that the study data is accurate. Participants must undergo a unified training, unified recording methods and criteria. The entire clinical trial procedure should be performed under stringent procedures. The investigator should record the contents of the CRF carefully and faithfully according to the requirements of the case report form, so as to ensure the integrity and reliability of the report form. All observations and findings in clinical trials should be verified to ensure data reliability and to ensure that the conclusions from clinical trials are derived from the original data. In the clinical trial and data processing stage has the corresponding data management measures.All CRF and original hospital records should be validated, and all original signed patient consent forms, all CRFs, CRFs, and CRFs should be carefully filled out, including confirmation of all participants (valid for different records, such as CRFs and hospital records) Detailed records of drug distribution. After the trial, all the clinical research data to the pharmacological office to save.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-11-02
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