中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2500113796
最近更新日期： Date of Last Refreshed on：	2025-12-03 10:42:48
注册时间： Date of Registration：	2025-12-03 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	人工可延长膝关节假体前瞻性、随机对照临床试验
Public title：	Prospective, Randomized Controlled Clinical Trial of an Artificial Extendable Knee Joint Prosthesis
注册题目简写：
English Acronym：
研究课题的正式科学名称：	人工可延长膝关节假体前瞻性、随机对照临床试验
Scientific title：	Prospective, Randomized Controlled Clinical Trial of Artificial Extendable Knee Joint Prosthesis
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：	沈嘉康	研究负责人：	沈嘉康
Applicant：	Jiakang Shen	Study leader：	Jiakang Shen
申请注册联系人电话： Applicant telephone：	+86 13761084197	研究负责人电话： Study leader's telephone：	+86 21 63240090
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：	shenjiakang2012@163.com	研究负责人电子邮件： Study leader's E-mail：	014187sjk@shgh.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：	上海市虹口区武进路86号	研究负责人通讯地址：	上海市虹口区武进路85号
Applicant address：	No. 86, Wujin Road, Hongkou District, Shanghai	Study leader's address：	No. 85, Wujin Road, Hongkou District, 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：	上海市第一人民医院
Applicant's institution：	Shanghai General Hospital
研究负责人所在单位：	上海市第一人民医院
Affiliation of the Leader：	Shanghai General 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：	院伦审【2025】254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：	上海市第一人民医院人体试验伦理审查委员会
Name of the ethic committee：	Shanghai General Hospital Institutional Review Board
伦理委员会批准日期： Date of approved by ethic committee：	2025-11-24 00:00:00
伦理委员会联系人：	耿雯倩
Contact Name of the ethic committee：	Geng Wenqian
伦理委员会联系地址：	上海市虹口区武进路85号
Contact Address of the ethic committee：	No. 85, Wujin Road, Hongkou District, Shanghai
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 21 36126254	伦理委员会联系人邮箱： Contact email of the ethic committee：	13262983906@163.com

研究实施负责（组长）单位：

上海市第一人民医院

Primary sponsor：

Shanghai General Hospital

研究实施负责（组长）单位地址：

上海市虹口区武进路85号

Primary sponsor's address：

No. 85, Wujin Road, Hongkou District, 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)：	上海市第一人民医院	具体地址：	上海市虹口区武进路85号
Institution hospital：	Shanghai General Hospital	Address：	No. 85, Wujin Road, Hongkou District, Shanghai

经费或物资来源：

青苗计划

Source(s) of funding：

Seedings Program

研究疾病：

原发性恶性骨肿瘤

Target disease：

Primary malignant bone tumors

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：

其它

Study phase：

N/A

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

通过收集临床数据评价山东威高医疗器械有限公司生产的可延长铰链膝关节假体系统在消除患者双下肢不等长的有效性。

Objectives of Study：

To evaluate the efficacy of the extendable hinged knee prosthesis system manufactured by Shandong Wego Medical Devices Co., Ltd. in eliminating limb-length discrepancy by collecting clinical data.

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.拟切除瘤段长度小于 14cm； 2.预期生存期小于 2 年； 3.有其他手术禁忌症者； 4.3 个月内参加过其他临床试验者； 5.研究者认为不适合参与试验的患者；

Exclusion criteria：

1.The length of the tumor segment to be removed is less than 14 cm. 2.Expected survival period is less than 2 years. 3.Those with other surgical contraindications; 4.Those who have participated in other clinical trials within the past 3 months; 5.The researchers consider that patients who is not suitable for participating in the trial.

研究实施时间：

Study execute time：

从 From 2025-12-01 00:00:00至 To 2027-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-01-01 00:00:00 至 To 2026-06-30 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	15
Group：	The experimental group	Sample size：	15
干预措施：	使用人工可延长膝关节假体进行保肢手术	干预措施代码：
Intervention：	Do limb salvage surgeries with artificial extendable knee joint endoprostheses.	Intervention code：

组别：	对照组	样本量：	15
Group：	The control group	Sample size：	15
干预措施：	使用常规膝关节假体进行保肢手术。	干预措施代码：
Intervention：	Do limb salvage surgeries with conventional knee joint endoprostheses.	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)：	上海市第一人民医院	单位级别：	三级甲等
Institution hospital：	Shanghai General Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	肌肉骨骼肿瘤协会评分	指标类型：	次要指标
Outcome：	Musculo-Skeletor tumor society score（MSTS）	Type：	Secondary indicator
测量时间点：	24、48、72、108周	测量方法：	问卷评分
Measure time point of outcome：	24、48、72、108 weeks	Measure method：	Questionnaire scoring.

指标中文名：	可视化疼痛评分	指标类型：	次要指标
Outcome：	Visual Pain Score	Type：	Secondary indicator
测量时间点：	24、48、72、108周	测量方法：	随访问卷评分。
Measure time point of outcome：	24、48、72、108 weeks	Measure method：	Questionnaire scoring.

指标中文名：	单纯膝关节功能评分	指标类型：	次要指标
Outcome：	Simple Knee Function Score	Type：	Secondary indicator
测量时间点：	24、48、72、108周	测量方法：
Measure time point of outcome：	24、48、72、108 weeks	Measure method：

指标中文名：	双下肢不等长	指标类型：	主要指标
Outcome：	Lower-limb discrepancy	Type：	Primary indicator
测量时间点：	108周	测量方法：	患者拍摄双下肢全长片，由第三方人员在PACS系统上测量对比双侧下肢总长度。
Measure time point of outcome：	108th weeks	Measure method：	The patient underwent full-length X-ray examinations of both lower limbs. A third-party researcher measured and compared the total lengths of the bilateral lower limbs on the PACS system.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	无	组织：
Sample Name：	NA	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	10	岁 years
最大 Max age	14	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）：

由中央随机系统产生随机数列。

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

Non-research team members are grouped using a central random

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：	开放标签
Blinding：	Open-label study

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)：	N/A
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：	本随机对照试验采用纸质病例报告表（CRF）收集数据，后续通过电子录入方式建立研究数据库。数据管理员根据研究方案要求设计标准化的纸质CRF，确保表格逻辑清晰、易于填写，特别设计随机化记录表、治疗分配表、依从性评估表、主要终点评估表、不良事件报告表等RCT专用表格，包含所有研究变量的规范录入格式和编码规则。随机化程序采用独立的中央随机化系统或随机化信封，确保分配隐藏的完整性。研究者或临床研究协调员负责在纸质CRF上及时、真实、完整地记录每位受试者在研究中的所有相关资料，包括筛选入组过程、随机化信息、治疗执行情况、疗效评估、安全性监测、依从性评价和脱落退出等关键信息，确保字迹清晰、信息准确。数据录入采用双人独立录入模式，由经过GCP培训的数据录入员根据纸质CRF进行数据录入。录入过程特别关注随机化序号的准确性、治疗分配的一致性、主要终点数据的完整性和不良事件的准确分类。两人独立完成后进行一致性核查，对不一致的数据项进行核实和纠正，确保关键数据的准确性。数据管理员建立针对本研究的标准化质量控制程序，通过数据库查询或统计软件脚本定期执行质量检查，重点关注随机化平衡性检查、基线特征可比性验证、主要终点数据完整性评估、治疗依从性分析、不良事件报告完整性检查、脱落模式分析和缺失数据影响评估。质量控制特别关注可能影响试验结果解释的关键数据质量问题。当发现数据问题时，数据管理员生成标准化的数据疑问表，详细列出需要澄清的问题，包括随机化程序执行、治疗分配准确性、主要终点事件判定、不良事件因果关系评估、治疗依从性评价、脱落原因分析等关键问题。研究者收到疑问表后进行书面解答并签名确认，对于涉及终点事件判定的复杂问题，可由独立的终点事件评估委员会进行裁决。数据录入员根据研究者的答疑结果进行相应的数据修改和录入。整个疑问处理过程建立完整的书面记录，包括疑问内容、解答过程、临床判断依据和最终处理结果，确保数据修改的可追溯性和科学性。特别关注影响主要疗效分析和安全性评价的关键数据疑问处理。所有数据疑问解决后，数据管理人员对数据进行最终清理，生成"清洁"数据集和数据质量报告。质量报告包括随机化执行情况、基线特征平衡性、主要终点数据完整率、治疗依从性分布、不良事件发生情况、脱落退出分析等临床试验关键质量指标。随后组织数据审核会议，由主要研究者、统计分析人员、数据管理人员、临床试验监查员和质量控制人员共同参与。数据审核会议全面审核随机化质量、治疗执行情况、主要终点数据质量、安全性数据完整性、缺失数据对不同分析集的影响，并对异常值和缺失数据处理做出决策。确认数据质量符合ITT分析、PPS分析和安全性分析的要求。各方代表在充分讨论基础上签署数据审核决议，特别确认主要疗效分析和安全性分析所需数据的质量和完整性。数据审核通过后，数据管理人员执行数据库锁定程序，建立最终分析数据集的版本控制记录，分别生成ITT分析集、PPS分析集和安全性分析集，并将锁定数据提交统计分析团队。纸质CRF作为原始资料妥善保存，建立完整的试验文档管理体系，包括随机化记录、治疗分配文档、数据收集表、疑问处理记录、终点事件裁决记录等。数据库锁定后如需进行任何数据变更，必须有充分的科学依据和临床合理性，经主要研究者、统计学家、数据管理员和监查员共同签署同意书后方可执行，并详细记录变更的完整过程和对分析结果的潜在影响。研究建立严格的数据安全保密措施，维护盲法试验的盲法完整性，限制数据访问权限，对涉及个人身份信息的数据进行去标识化处理，确保符合相关要求和相关法规。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	This randomized controlled trial (RCT) collected data using paper Case Report Forms (CRFs) and subsequently established a study database through electronic data entry. The data manager designed standardized paper CRFs in accordance with the study protocol to ensure that the forms were logically clear and easy to complete. Specifically, dedicated RCT forms such as randomization record forms, treatment allocation forms, adherence assessment forms, primary endpoint assessment forms, and adverse event reporting forms were designed. These forms included standardized entry formats and coding rules for all study variables.The randomization procedure used an independent central randomization system or randomization envelopes to ensure the integrity of allocation concealment. Investigators or clinical research coordinators were responsible for recording all relevant information of each participant in the study on the paper CRFs in a timely, accurate, and complete manner. This included the screening and enrollment process, randomization information, treatment implementation, efficacy evaluation, safety monitoring, adherence assessment, and dropout or withdrawal status. They ensured that the handwriting was clear and the information was accurate.Data entry was conducted using a dual-independent entry mode by data entry staff who had undergone Good Clinical Practice (GCP) training, based on the paper CRFs. During the entry process, special attention was paid to the accuracy of randomization numbers, consistency of treatment allocation, completeness of primary endpoint data, and accurate classification of adverse events. After both individuals independently completed the entry, a consistency check was performed. Any inconsistent data items were verified and corrected to ensure the accuracy of key data.The data manager established a standardized quality control procedure for this study. Regular quality checks were conducted through database queries or statistical software scripts, focusing on randomization balance checks, comparability of baseline characteristics, completeness assessment of primary endpoint data, treatment adherence analysis, adverse event reporting completeness, dropout pattern analysis, and missing data impact assessment. Quality control particularly focused on key data quality issues that might affect the interpretation of trial results.When data issues were identified, the data manager generated a standardized data query form, detailing the questions that needed clarification. These included key issues such as randomization procedure execution, accuracy of treatment allocation, primary endpoint event determination, causality assessment of adverse events, treatment adherence evaluation, and dropout reason analysis. Investigators were required to provide written answers and sign off on the responses. For complex issues involving endpoint event determination, an independent endpoint event adjudication committee could make the final decision.Data entry staff made corresponding data modifications and entries based on the investigators’ responses to the queries. The entire query handling process was documented in writing, including the content of the queries, the response process, clinical judgment basis, and final resolution, to ensure the traceability and scientific nature of data modifications. Special attention was given to the handling of key data queries affecting primary efficacy analysis and safety evaluation.After all data queries were resolved, the data manager conducted the final data cleaning and generated a “clean” dataset and a data quality report. The quality report included key clinical trial quality indicators such as randomization execution, baseline characteristic balance, primary endpoint data completion rate, treatment adherence distribution, adverse event occurrence, and dropout analysis. Subsequently, a data review meeting was organized, involving the principal investigator, statisticians, data managers, clinical trial monitors, and quality control personnel.The data review meeting comprehensively reviewed the quality of randomization, treatment implementation, primary endpoint data quality, safety data completeness, and the impact of missing data on different analysis sets. Decisions were made on the handling of outliers and missing data. The data quality was confirmed to meet the requirements for Intention-to-Treat (ITT) analysis, Per-Protocol Set (PPS) analysis, and safety analysis. All representatives signed off on the data review resolution after full discussion, particularly confirming the quality and completeness of data required for primary efficacy and safety analyses.After the data review was passed, the data manager executed the database lock procedure, established version control records for the final analysis dataset, and generated ITT analysis set, PPS analysis set, and safety analysis set. The locked data were then submitted to the statistical analysis team. The paper CRFs were properly preserved as original documents, and a complete trial document management system was established, including randomization records, treatment allocation documents, data collection forms, query handling records, and endpoint event adjudication records.After the database was locked, any data changes required sufficient scientific justification and clinical rationality. Such changes could only be executed after obtaining the joint approval of the principal investigator, statistician, data manager, and monitor, with detailed documentation of the entire change process and its potential impact on the analysis results. The study established strict data security and confidentiality measures to maintain the integrity of blinding in blinded trials, restricted data access, and de-identified personal information to ensure compliance with relevant requirements and regulations.
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2025-12-03 10:42:34