Today is 2021-07-24

BMP-2/CPC scaffold with dexamethasone-loaded blood clot embedment accelerates clinical bone regeneration
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注册号:

Registration number:

ChiCTR2100047693 

最近更新日期:

Date of Last Refreshed on:

2021-06-22 

注册时间:

Date of Registration:

2021-06-22 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

固载 rhBMP-2 的活性磷酸钙骨水泥多孔支架协同地塞米松、包覆血块的骨修复性能临床究 

Public title:

BMP-2/CPC scaffold with dexamethasone-loaded blood clot embedment accelerates clinical bone regeneration 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

固载 rhBMP-2 的活性磷酸钙骨水泥多孔支架协同地塞米松、包覆血块的骨修复性能临床究 

Scientific title:

BMP-2/CPC scaffold with dexamethasone-loaded blood clot embedment accelerates clinical bone regeneration 

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:

李博 

研究负责人:

李波 

Applicant:

Bo Li 

Study leader:

Bo Li 

申请注册联系人电话:

Applicant telephone:

+86 18685193668 

研究负责人电话:

Study leader's telephone:

+86 13985166647 

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:

myronlee@163.com 

研究负责人电子邮件:

Study leader's E-mail:

libo3@medmail.com.cn 

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:

贵州省贵阳市云岩区中山东路83号 

研究负责人通讯地址:

贵州省贵阳市云岩区中山东路83号 

Applicant address:

83 Zhongshan Road East, Yunyan District, Guiyang, Guizhou, China 

Study leader's address:

83 Zhongshan Road East, Yunyan District, Guiyang, Guizhou, China 

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:

贵州省人民医院 

Applicant's institution:

Guizhou Provincial 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:

伦审字(科研)(2019)28号 

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:

贵州省人民医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Guizhou Provincial People's Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-04-10 

伦理委员会联系人:

邓蕊 

Contact Name of the ethic committee:

Rui Deng 

伦理委员会联系地址:

贵州省贵阳市云岩区中山东路83号 

Contact Address of the ethic committee:

83 Zhongshan Road East, Yunyan District, Guiyang, Guizhou, 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:

贵州省人民医院 

Primary sponsor:

Guizhou Provincial People's Hospital 

研究实施负责(组长)单位地址:

贵州省贵阳市云岩区中山东路83号 

Primary sponsor's address:

83 Zhongshan Road East, Yunyan District, Guiyang, Guizhou, 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):

贵州省

市(区县):

Country:

China

Province:

Guizhou

City:

单位(医院):

贵州省人民医院

具体地址:

贵州省贵阳市云岩区中山东路83号

Institution
hospital:

Guizhou Provincial People's Hospital

Address:

83 Zhongshan Road East, Yunyan District, Guiyang

经费或物资来源:

国家自然科学基金委员会 

Source(s) of funding:

National Natural Science Foundation of China  

研究疾病:

骨缺损 

Target disease:

Bone defect 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

骨组织缺损的修复与重建一直是现代医学力求解决的难题。据统计,每年有数以百万计的患者因创伤、感染、肿瘤、发育异常等原因造成大的骨缺损,单纯依靠骨组织自修复无法愈合,需要接受手术治疗。加上现代交通的发展导致高能量损伤的增加,以及人类老龄化趋势增长导致骨质疏松群体的加大,使骨组织缺损患者数量呈现明显上升的趋势。因此,骨缺损或骨折已成为影响人们健康和生活的一种严重的社会问题。 骨组织缺损患者数目的巨大直接导致对骨组织修复治疗材料和器械的巨大需求市场。目前,骨组织修复与重建主要采用的治疗手段为骨组织移植和人工骨修复替换材料。其中,人工骨修复材料不仅克服了自体骨移植“以伤治伤”和来源有限的缺陷,而且解决了异体骨移植后存在的免疫排斥反应以及潜在的病源传播的危险,近年来在临床上获得较为广泛的应用。然而,目前市场所提供的骨组织修复材料和器械相当有限,仅占整个市场需求量的10%。同时,材料在体内的成骨活性有待进一步提高。尽管目前临床所使用的人工骨材料(主要包括磷酸钙类、生物微晶玻璃类和天然高分子材料-胶原类)在组成(无机成分或有机成分)或三维结构等某一方面很好地模拟了人体天然骨,然而对于极为复杂的人体组织修复过程而言,这些功能支架材料在人体内的生物活性仍然欠佳,临床修复效果并不十分理想。因此,开发和研究满足临床需求的新型高活性人工骨修复材料,不仅具有十分广阔的市场前景,会带来巨大的经济效益,而且会产生持久的救死扶伤和提高人民健康水平的社会意义。 

Objectives of Study:

Repair and reconstruction of bone tissue defect has always been a difficult problem in modern medicine. According to statistics, millions of patients every year due to trauma, infection, tumor, abnormal development and other reasons caused by large bone defects, simply rely on the bone tissue self-repair can not heal, need to receive surgical treatment. In addition, the development of modern transportation leads to the increase of high energy damage, and the aging trend of human beings leads to the increase of osteoporosis group, so that the number of patients with bone tissue defect presents a significant upward trend. Therefore, bone defect or fracture has become a serious social problem that affects people's health and life. The huge number of patients with bone tissue defect directly leads to the huge market demand for bone tissue repair and treatment materials and instruments. At present, the main treatment methods for bone tissue repair and reconstruction are bone tissue transplantation and artificial bone replacement materials. Among them, artificial bone repair materials not only overcome the defects of autologous bone transplantation "treating injury with injury" and limited source, but also solve the risk of immune rejection and potential disease transmission after allogeneic bone transplantation, so they have been widely used in clinical practice in recent years. However, the current market supply of bone tissue repair materials and devices is quite limited, accounting for only 10% of the total market demand. Meanwhile, the osteogenic activity of the material in vivo needs to be further improved. Although the clinical use of artificial bone materials (mainly including calcium phosphate, biological glass-ceramics and natural polymer materials - collagen type) in composition (inorganic composition or organic ingredients) or one of three dimensional structure well simulates the human natural bone, however, for the human body tissue repair process is very complex, The biological activity of these functional scaffolds in human body is still poor and the clinical repair effect is not very ideal. Therefore, the development and research of new high-activity artificial bone repair materials to meet the clinical needs will not only have a very broad market prospect, will bring huge economic benefits, but also have a lasting social significance of saving the dying and healing the wounded and improving people's health. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

1、年龄20-50岁之间; 2、包含塌陷、需要植入人工骨的胫骨平台骨折或肱骨近端骨折; 3、了解并愿意遵守术后康复程序; 4、同意进行术后随访和相关测试; 5、签署知情同意书。 

Inclusion criteria

1. Aged 20 to 50 years; 2. Tibial plateau fractures or proximal humeral fractures that involves collapse and requires implantation of bone-grafting materials; 3. An understanding of the rehabilitation protocol and willing to follow it; 4. An agreement to postoperative visits and tests; 5. Signed an informed subject consent form.  

排除标准:

1、患有不可控的系统性疾病(如糖尿病,血液/免疫缺陷等); 2、有关节炎等骨科疾病史的; 3、其他临床上不适宜进行植骨手术的患者。 

Exclusion criteria:

1. Patients with systemic illness including diabetes, bleeding disorder, hypertension, etc. 2. Patients with orthopaedic medical history including arthritis. 

研究实施时间:

Study execute time:

From2019-04-03To 2021-06-16 

征募观察对象时间:

Recruiting time:

From2019-04-04To 2020-04-04 

干预措施:

Interventions:

组别:

Dex/blood/BMP-2/CPC支架

样本量:

10

Group:

Dex/blood/BMP-2/CPC scaffold

Sample size:

干预措施:

植入带有活性因子的人工骨

干预措施代码:

Intervention:

Implantation of artificial bone graft with bioactive factor

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

贵州省 

市(区县):

 

Country:

China 

Province:

Guizhou 

City:

 

单位(医院):

贵州省人民医院 

单位级别:

三级甲等医院 

Institution
hospital:

Guizhou Provincial People's Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

放射影像学结果

指标类型:

主要指标 

Outcome:

Radiography

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

功能评分

指标类型:

主要指标 

Outcome:

Function 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:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 32 years
最大 Max age 41 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):

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

None

盲法:

N/A

Blinding:

N/A

是否共享原始数据:

IPD sharing

Yes

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):

临床试验公共管理平台 ResMan(www.medresman.org)

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

ResMan website, a public platform for clinical trial management (www.medresman.org)

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:

临床试验公共管理平台 ResMan(www.medresman.org)

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

ResMan website, a public platform for clinical trial management (www.medresman.org)

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2021-06-22
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