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智能规划指导全膝关节置换术（TKA）治疗K-L Ⅳ期膝关节骨关节炎的研究
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注册号：

Registration number：

 ChiCTR2500104334 

最近更新日期：

Date of Last Refreshed on：

 2025-06-16 09:36:05 

注册时间：

Date of Registration：

 2025-06-16 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

智能规划指导全膝关节置换术（TKA）治疗K-L Ⅳ期膝关节骨关节炎的研究

Public title：

A study of intelligent planning guided total knee arthroplasty (TKA) for K-L stage Ⅳ knee osteoarthritis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

智能规划指导全膝关节置换术（TKA）治疗K-L Ⅳ期膝关节骨关节炎的多中心研究

Scientific title：

A multicenter study of intelligent planning guided total knee arthroplasty (TKA) for K-L stage Ⅳ knee osteoarthritis

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：

郭林 

研究负责人：

郭林 

Applicant：

Guo Lin 

Study leader：

Guo Lin 

申请注册联系人电话：

Applicant telephone：

 +86 13883007291

研究负责人电话：

Study leader's
telephone：

+86 23 68765797

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：

 guolin6212@163.com

研究负责人电子邮件：

Study leader's E-mail：

 guolin6212@163.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：

重庆市沙坪坝区高滩岩正街29号

研究负责人通讯地址：

重庆市沙坪坝区高滩岩正街29号

Applicant address：

No. 29, Gaotan Yan Zheng Street, Shapingba District, Chongqing

Study leader's address：

No. 29, Gaotan Yan Zheng Street, Shapingba District, Chongqing

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：

中国人民解放军陆军军医大学第一附属医院

Applicant's institution：

The First Affiliated Hospital of Army Medical University

研究负责人所在单位：

中国人民解放军陆军军医大学第一附属医院

Affiliation of the Leader：

The First Affiliated Hospital of Army Medical University

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：

 （A）KY2025115

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：

中国人民解放军陆军军医大学第一附属医院伦理委员会

Name of the ethic committee：

Ethics Committee of the First Affiliated Hospital of Army Medical University PLA

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-05-30 00:00:00

伦理委员会联系人：

贺莉

Contact Name of the ethic committee：

He Li

伦理委员会联系地址：

重庆市沙坪坝区高滩岩正街29号

Contact Address of the ethic committee：

No. 29, Gaotan Yan Zheng Street, Shapingba District, Chongqing

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 23 68754035

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 cqhl13@qq.com

研究实施负责（组长）单位：

中国人民解放军陆军军医大学第一附属医院

Primary sponsor：

The First Affiliated Hospital of Army Medical University

研究实施负责（组长）单位地址：

重庆市沙坪坝区高滩岩正街29号

Primary sponsor's address：

No. 29, Gaotan Yan Zheng Street, Shapingba District, Chongqing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

重庆

市(区县)：

Country：

China

Province：

Chongqing

City：

单位(医院)：

中国人民解放军陆军军医大学第一附属医院

具体地址：

重庆市沙坪坝区高滩岩正街29号

Institution
hospital：

The First Affiliated Hospital of Army Medical University

Address：

No. 29, Gaotan Yan Zheng Street, Shapingba District, Chongqing

经费或物资来源：

临床研究孵化项目

Source(s) of funding：

Clinical research incubation project

研究疾病：

膝关节骨关节炎  

Target disease：

Osteoarthritis of knee joint

研究疾病代码：

Target disease code：

研究类型：

诊断试验

Study type：

Diagnostic test

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

诊断试验诊断准确性 

Study design：

Diagnostic test for accuracy 

研究目的：

本项目通过多中心临床试验研究，评估TKA智能术前规划软件的准确度是否不劣于计算机辅助人工术前规划，验证TKA智能术前规划治疗K-L IV期重度膝关节骨关节炎的有效性，为推广智能术前规划在TKA中的应用提供临床证据。  

Objectives of Study：

This project evaluates whether the accuracy of TKA intelligent preoperative planning software is not inferior to computer-assisted artificial preoperative planning, verifies the effectiveness of TKA intelligent preoperative planning in the treatment of K-L stage IV severe knee osteoarthritis, and provides clinical evidence for promoting the application of intelligent preoperative planning in TKA.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

1.伴有下肢类风湿性关节炎；
2.伴有重度髋关节或踝关节骨性关节炎；
3.既往存在下肢骨折、畸形或先天性异常等；
4.曾有患侧膝关节手术史；
5.曾接受同侧髋关节或踝关节置换手术治疗；
6.曾接受改变下肢力线的其他手术治疗；
7.合并严重高血压、糖尿病、冠心病、精神疾病等影响手术的危险因素；

Exclusion criteria：

1.With rheumatoid arthritis of lower extremities;
2.With severe hip or ankle osteoarthritis;
3.Previous lower limb fractures, deformities or congenital anomalies;
4.Had a history of knee surgery on the affected side;
5.Has been treated with ipsilateral hip or ankle replacement surgery;
6.Had received other surgical treatments to change the force line of the lower limbs;
7.Risk factors associated with severe hypertension, diabetes, coronary heart disease, mental illness and other factors affecting surgery;

研究实施时间：

Study execute time：

从 From 2025-06-30 00:00:00至 To 2027-11-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-06-30 00:00:00 至 To 2027-11-30 00:00:00

诊断试验：

Diagnostic Tests：

金标准或参考标准（即可准确诊断某疾病的单项方法或多项联合方法，在本研究中用于诊断是否有该病的临床参考标准）：

参照2022年国家卫生健康委办公厅发布的《髋膝关节置换术操作规范（2022年版）》确定TKA术中关键技术操作标准专家共识，以各医院主刀医生严格按照专家共识在术中根据患者真实骨骼特点的实际截骨参数为参考标准，包括股骨远髁厚度差、股骨冠状面远端外翻角、股骨后髁截骨厚度差、股骨后髁旋转截骨角度、胫骨平台截骨厚度差、胫骨后倾角、股骨及胫骨假体型号。

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

Referring to the “Hip and Knee Arthroplasty Operation Standards (2022 Edition)” issued by the General Office of the National Health and Wellness Commission in 2022 to determine the expert consensus on the key technical operation standards for TKA, the actual osteotomy parameters in accordance with

指标试验（即本研究的待评估诊断试验，无论为方法、生物标志物或设备，均请列出名称）：

AI人工全膝关节置换术前规划软件

Index test:

AI Total Knee Replacement Preoperative Planning Software

目标人群（可以是某种疾病患者或正常人群，详细描述其疾病特征，注意应纳入符合分布特点的全序列病例，具有良好的代表性）

诊断为K-L Ⅳ期膝关节骨关节炎且达到行TKA手术指征的患者（行AI术前规划）

例数:

Sample size:

210

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

Patients diagnosed with K-L stage IV knee osteoarthritis and reaching the indication for TKA surgery (preoperative planning for AI)

容易混淆的疾病人群（即与目标疾病不易区分的一种或多种不同疾病，应避免采用正常人群对照的病例-对照设计）：

诊断为K-L Ⅳ期膝关节骨关节炎且达到行TKA手术指征的患者（行人工术前规划）

例数:

Sample size:

210

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

Patients diagnosed with K-L stage IV knee osteoarthritis and reaching the indication for TKA surgery (preoperative planning for manual)

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 重庆 

市(区县)：

  

Country：

China

Province：

Chongqing

City：

单位(医院)：

 中国人民解放军陆军军医大学第一附属医院 

单位级别：

 三甲 

Institution
hospital：

The First Affiliated Hospital of Army Medical University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

  

Country：

China

Province：

Guangdong

City：

单位(医院)：

 中山市中医院 

单位级别：

 三甲 

Institution
hospital：

Zhongshan Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 重庆 

市(区县)：

  

Country：

China

Province：

Chongqing

City：

单位(医院)：

 重庆医科大学附属第二医院 

单位级别：

 三甲 

Institution
hospital：

The Second Affiliated Hospital of Chongqing Medical University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 陕西 

市(区县)：

  

Country：

China

Province：

Shaanxi

City：

单位(医院)：

 西安交通大学第二附属医院 

单位级别：

 三甲 

Institution
hospital：

Xi'an Jiaotong University Second Affiliated Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

股骨冠状面远端外翻角（股骨机械轴和股骨远端解剖轴冠状面夹角）

指标类型：

次要指标

Outcome：

Valgus angle of distal femur in coronal plane (included angle between mechanical axis of femur and anatomical axis of distal femur in coronal plane)

Type：

Secondary indicator

测量时间点：

术前、术中

测量方法：

术前由AI术前规划组、计算机辅助人工术前规划组使用患者下肢CT图像进行重建模型，在模型上根据骨性标记点测量得出股骨冠状面远端外翻角；术中，手术医生会使用截骨工具对股骨远端进行截骨，截骨时所选取的角度即为术中实际股骨冠状面远端外翻角

Measure time point of outcome：

Preoperative and intraoperative

Measure method：

Before operation, the AI preoperative planning group and the computer-assisted manual preoperative planning group used the patient's lower limb CT images to reconstruct the model, and the distal femoral valgus angle in the coronal plane was measured according to the bony marker points on the model; Intraoperatively, the surgeon will use the osteotomy tool to osteotomy the distal femur, and the angle selected during osteotomy is the actual intraoperative valgus angle of the distal femur in the co

指标中文名：

股骨后髁旋转截骨角度（股骨通髁线与后髁线夹角）

指标类型：

次要指标

Outcome：

Rotational osteotomy angle of posterior femoral condyle (included angle between femoral condylar line and posterior condylar line)

Type：

Secondary indicator

测量时间点：

术前、术中

测量方法：

术前由AI术前规划组、计算机辅助人工术前规划组使用患者下肢CT图像进行重建模型，在模型上根据骨性标记点测量得出股骨后髁旋转截骨角；术中，手术医生会使用截骨工具对股骨后髁进行截骨，截骨时所选取的角度即为术中实际股骨后髁旋转截骨角

Measure time point of outcome：

Preoperative and intraoperative

Measure method：

Before operation, the AI preoperative planning group and the computer-assisted manual preoperative planning group used the patient's lower limb CT images to reconstruct the model, and the rotational osteotomy angle of the posterior femoral condyle was measured according to the bony marker points on the model; Intraoperatively, the surgeon will use the osteotomy tool to osteotomy the posterior femoral condyle, and the angle selected during osteotomy is the actual intraoperative rotational osteoto

指标中文名：

股骨远端内外髁的截骨厚度差（股骨远端外髁厚度减去内髁厚度）

指标类型：

主要指标

Outcome：

The difference in osteotomy thickness between the medial and lateral condyles of the distal femur (the thickness of the lateral condyle of the distal femur minus the thickness of the medial condyle)

Type：

Primary indicator

测量时间点：

术前、术中

测量方法：

术前由AI术前规划组、计算机辅助人工术前规划组使用患者下肢CT图像进行重建模型，在模型上进行虚拟手术得到股骨内外髁的截骨厚度；术中则由手术医生直接使用游标卡尺测量，得到实际股骨内外髁的截骨厚度

Measure time point of outcome：

Preoperative and intraoperative

Measure method：

Before operation, the AI preoperative planning group and the computer-assisted manual preoperative planning group used the patient's lower limb CT images to reconstruct the model, and performed virtual surgery on the model to obtain the osteotomy thickness of the femoral medial and lateral condyles; During the operation, the surgeon directly measured the actual osteotomy thickness of the medial and lateral femoral condyles using a vernier caliper

指标中文名：

膝关节学会评分

指标类型：

次要指标

Outcome：

Knee Society Score, KSS

Type：

Secondary indicator

测量时间点：

术前、术后6周、3个月、半年、1年

测量方法：

术后根据时间（术前、术后6周、3个月、半年、1年）通过线上的方式对患者进行随访，随访的主要方式通过KSS问卷来进行，根据问卷上的内容来记录该患者的每个选项，根据评分规则得到膝关节功能评分

Measure time point of outcome：

Before operation, 6 weeks, 3 months, half a year and 1 year after operation

Measure method：

The patients were followed up online according to the time (Before operation, 6 weeks, 3 months, half a year and 1 year after operation). The main way of follow-up was through the KSS questionnaire. According to the content of the questionnaire, each option of the patient was recorded, and the knee function score was obtained according to the scoring rules

指标中文名：

视觉模拟量表

指标类型：

次要指标

Outcome：

Visual Analogue Scale, VAS

Type：

Secondary indicator

测量时间点：

术前、术后6周、3个月、半年、1年

测量方法：

术后根据时间（术前、术后6周、3个月、半年、1年）通过线上的方式对患者进行随访，随访的主要方式通过VAS问卷来进行，根据问卷上的内容来记录该患者的每个选项，根据评分规则得到膝关节功能评分

Measure time point of outcome：

Before operation, 6 weeks, 3 months, half a year and 1 year after operation

Measure method：

The patients were followed up online according to the time (Before operation, 6 weeks, 3 months, half a year and 1 year after operation). The main way of follow-up was through the VAS questionnaire. According to the content of the questionnaire, each option of the patient was recorded, and the knee function score was obtained according to the scoring rules

指标中文名：

股骨及胫骨假体型号

指标类型：

次要指标

Outcome：

Size of femoral and tibial prostheses

Type：

Secondary indicator

测量时间点：

术前、术中

测量方法：

术前由AI术前规划组、计算机辅助人工术前规划组使用患者下肢CT图像进行重建模型，在模型上进行虚拟手术得到股骨、胫骨的假体型号；手术时则直接记录手术医生植入患者体内的假体型号大小

Measure time point of outcome：

Preoperative and intraoperative

Measure method：

Before operation, AI preoperative planning group and computer-assisted artificial preoperative planning group used the patient's lower limb CT images to reconstruct the model, and performed virtual surgery on the model to obtain the prosthesis models of femur and tibia; During the operation, the model and size of the prosthesis implanted into the patient by the surgeon were directly recorded

指标中文名：

膝关节损伤与骨关节炎结局评分

指标类型：

次要指标

Outcome：

Knee Injury and Osteoarthritis Outcome Score,KOOS

Type：

Secondary indicator

测量时间点：

术前、术后6周、3个月、半年、1年

测量方法：

术后根据时间（术前、术后6周、3个月、半年、1年）通过线上的方式对患者进行随访，随访的主要方式通过KOOS问卷来进行，根据问卷上的内容来记录该患者的每个选项，根据评分规则得到膝关节功能评分

Measure time point of outcome：

Before operation, 6 weeks, 3 months, half a year and 1 year after operation

Measure method：

The patients were followed up online according to the time (Before operation, 6 weeks, 3 months, half a year and 1 year after operation). The main way of follow-up was through the KOOS questionnaire. According to the content of the questionnaire, each option of the patient was recorded, and the knee function score was obtained according to the scoring rules

指标中文名：

股骨后髁截骨厚度差（股骨外后髁截骨厚度减去股骨内后髁截骨厚度）

指标类型：

次要指标

Outcome：

Difference in osteotomy thickness of posterior femoral condyle (osteotomy thickness of lateral femoral condyle minus osteotomy thickness of medial femoral condyle)

Type：

Secondary indicator

测量时间点：

术前、术中

测量方法：

术前由AI术前规划组、计算机辅助人工术前规划组使用患者下肢CT图像进行重建模型，在模型上进行虚拟手术得到股骨内外后髁的截骨厚度；术中则由手术医生直接使用游标卡尺测量，得到实际股骨内外后髁的截骨厚度

Measure time point of outcome：

Preoperative and intraoperative

Measure method：

Before operation, AI pre-operative planning group and computer-assisted manual pre-operative planning group used the patient's lower limb CT images to reconstruct the model, and performed virtual surgery on the model to obtain the osteotomy thickness of the internal and external posterior femoral condyles; During the operation, the surgeon directly measured the actual osteotomy thickness of the internal and external posterior condyles of the femur with a vernier caliper

指标中文名：

胫骨平台截骨厚度差（内侧胫骨平台截骨厚度减去外侧胫骨平台截骨厚度）

指标类型：

次要指标

Outcome：

Tibial plateau osteotomy thickness difference (medial tibial plateau osteotomy thickness minus lateral tibial plateau osteotomy thickness)

Type：

Secondary indicator

测量时间点：

术前、术中

测量方法：

术前由AI术前规划组、计算机辅助人工术前规划组使用患者下肢CT图像进行重建模型，在模型上进行虚拟手术得到胫骨内外侧平台的截骨厚度；术中则由手术医生直接使用游标卡尺测量，得到实际胫骨内外侧平台的截骨厚度

Measure time point of outcome：

Preoperative and intraoperative

Measure method：

Before operation, the AI preoperative planning group and the computer-assisted manual preoperative planning group used the patient's lower limb CT images to reconstruct the model, and performed virtual surgery on the model to obtain the osteotomy thickness of the medial and lateral tibial plateau; Intraoperative, the surgeon directly measured the actual osteotomy thickness of the medial and lateral tibial plateau using a vernier caliper

指标中文名：

人工术前规划和AI术前规划的时间及经济成本

指标类型：

次要指标

Outcome：

Time and economic costs of manual preoperative planning and AI preoperative planning

Type：

Secondary indicator

测量时间点：

术前

测量方法：

统计人工术前规划和AI术前规划分别消耗的时间和花费

Measure time point of outcome：

Preoperative

Measure method：

Statistics on time consumed and spent on manual preoperative planning and AI preoperative planning, respectively

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

N/A

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 40 岁 years
最大 Max age 80 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）：

无

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

无

Blinding：

None

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）：

无

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：

1、研究者填写病例报告表的要求 1.1 研究者必须保证数据库录入的数据及时、完整、准确、真实。 1.2原则上数据填报后，将不能对数据进行任何修改。如确实存在错误，则需由提出人提出申请，备案后由数据管理员进行修改。 2、监查员对数据记录的监查 2.1监查员在研究过程中要定期登陆数据库检查受试者的知情同意及筛选纳入情况。 2.2监查员进行数据溯源，进行有关内容的核实，确认数据库记录及时、准确、规范、完整。 3、数据库建立 根据研究方案及病例报告表（CRF）的观察项目建立相应的录入程序，并设定录入时的逻辑审查限定条件，对数据库进行试运行，进而建立本研究专用的数据库系统。 4、数据录入、数据审核及疑问表递送 4.1 CRF的进一步检查：已经监查员审核的CRF交数据管理员，数据管理员对其进行全面检查，如有疑问，填写疑问表返回监查员，交研究者对疑问表中的问题进行书面解答并签名，交回数据管理员修正数据。疑问表应妥善保管。数据管理员无权修改原始数据。 4.2数据录入：对数据录入员培训后进行数据录入。 4.3数据的逻辑审核和合理性审核：根据方案要求和变量间的逻辑关系，对各类日期、受试者基本信息、入选标准、排除标准、病例脱落情况、数据缺失情况、主要指标极端值情况、衍生数据正确性、不良事件发生情况等进行程序性核查。如有疑问，同上类似，需填写疑问表返回监查员，交研究者对疑问表中的问题进行书面解答并签名，交回数据管理员修正数据。疑问表递送回收批量进行，直至所有问题得到解决。 5、数据库锁定 5.1数据库锁定：审核经确认的数据库可考虑锁定，交由统计人员进行统计分析。所谓的锁定系指将数据库由多方保存的形式。锁定的数据库任何一方一旦修改，通过交叉核对即可发现。 5.2数据锁定后原则上不得修改，如确属问题，需按照程序经临床研究单位确认后才可在统计分析程序中进行修正。数据管理及统计分析报告完成后，提交临床研究单位核查确认，撰写总结报告。

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

1. Requirements for researchers to fill in the case report form 1.1 the researcher must ensure that the data entered in the database is timely, complete, accurate and authentic. 1.2 in principle, no data can be modified after data filling. If there is any error, the applicant shall submit an application and the data administrator shall modify it after filing. 2. Supervisor's inspection of data records 2.1 during the study, the supervisor should regularly log in the database to check the informed consent and screening of the subjects. 2.2 the supervisor shall trace the data, verify the relevant contents, and confirm that the database records are timely, accurate, standardized and complete. 3. Database establishment According to the research protocol and the observation items of the case report form (CRF), the corresponding input procedures were established, and the logical review limiting conditions were set during the input. The database was commissioned, and then the special database system for this study was established. 4. Data entry, data review and query form delivery 4.1 further inspection of CRF: the CRF reviewed by the supervisor shall be submitted to the data administrator, who shall conduct a comprehensive inspection. If there is any doubt, fill in the question form and return it to the supervisor. The researcher shall answer the questions in the question form in writing and sign, and return it to the data administrator to correct the data. The query form should be kept properly. The data administrator does not have permission to modify the original data. 4.2 data entry: conduct data entry after training the data entry personnel. 4.3 logical review and rationality review of data: according to the requirements of the scheme and the logical relationship between variables, the procedural verification of various dates, basic information of subjects, inclusion criteria, exclusion criteria, case dropout, missing data, extreme values of main indicators, correctness of derivative data, occurrence of adverse events, etc. If there is any question, it is similar to the above. It is necessary to fill in the question form and return it to the supervisor, submit it to the researcher for written answers to the questions in the question form and sign, and return it to the data administrator to correct the data. The query form shall be delivered and recycled in batches until all problems are solved. 5. Database lock 5.1 database locking: the reviewed and confirmed database can be locked and submitted to the statistician for statistical analysis. The so-called locking refers to the form of keeping the database by multiple parties. Once any party of the locked database is modified, it can be found by cross checking. 5.2 in principle, the data cannot be modified after being locked. If it is a problem, it can only be modified in the statistical analysis program after being confirmed by the clinical research unit according to the procedure. After the completion of the data management and statistical analysis report, submit it to the clinical research unit for verification and confirmation, and write a summary report.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-06-16 09:35:53
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