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：	ChiCTR2600122308
最近更新日期： Date of Last Refreshed on：	2026-04-11 22:18:13
注册时间： Date of Registration：	2026-04-11 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	机器人手术治疗后交叉韧带胫骨止点撕脱骨折的多中心临床研究
Public title：	Multicenter Clinical Study on Robotic-Assisted Surgical Management of Posterior Cruciate Ligament Tibial Avulsion Fractures
注册题目简写：
English Acronym：
研究课题的正式科学名称：	机器人手术治疗后交叉韧带胫骨止点撕脱骨折的多中心临床研究
Scientific title：	Multicenter Clinical Study on Robotic-Assisted Surgical Management of Posterior Cruciate Ligament Tibial Avulsion Fractures
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：	刘魁	研究负责人：	余家阔
Applicant：	Liu Kui	Study leader：	Yu Jiekua
申请注册联系人电话： Applicant telephone：	+86 159 3265 0850	研究负责人电话： Study leader's telephone：	+86 133 3103 1448
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：	liukui8153@sina.com	研究负责人电子邮件： Study leader's E-mail：	yujiakuo@tsinghua.edu.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：	中国北京市昌平区立汤路168号	研究负责人通讯地址：	中国北京市昌平区立汤路168号
Applicant address：	168 Litang Road, Changping District, Beijing, China	Study leader's address：	168 Litang Road, Changping District, Beijing, 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：	北京清华长庚医院(清华大学临床医学院);石家庄市第三医院
Applicant's institution：	Beijing Tsinghua Changgung Hospital(School of Clinical Medicine, Tsinghua University), The Third Hospital of Shijiazhuang
研究负责人所在单位：	北京清华长庚医院(清华大学临床医学院)
Affiliation of the Leader：	Beijing Tsinghua Changgung Hospital(School of Clinical Medicine, Tsinghua 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：	26490-4-01	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：	北京清华长庚医院医学伦理委员会
Name of the ethic committee：	Medical Ethics Committee of Beijing Tsinghua Changgung Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2026-03-26 00:00:00
伦理委员会联系人：	刘曼婷
Contact Name of the ethic committee：	Liu Manting
伦理委员会联系地址：	中国北京市昌平区立汤路168号
Contact Address of the ethic committee：	168 Litang Road, Changping District, Beijing, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 10 5611 8567	伦理委员会联系人邮箱： Contact email of the ethic committee：	IRB@btch.edu.cn

研究实施负责（组长）单位：

北京清华长庚医院

Primary sponsor：

Beijing Tsinghua Changgung Hospital

研究实施负责（组长）单位地址：

中国北京市昌平区立汤路168号

Primary sponsor's address：

168 Litang Road, Changping District, Beijing, 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)：	北京	市(区县)：	昌平区
Country：	China	Province：	Beijing	City：	Beijing
单位(医院)：	北京清华长庚医院	具体地址：	中国北京市昌平区立汤路168号
Institution hospital：	Beijing Tsinghua Changgung Hospital	Address：	168 Litang Road, Changping District, Beijing, China.

经费或物资来源：

自筹

Source(s) of funding：

Self-funded

研究疾病：

后交叉韧带胫骨止点撕脱骨折

Target disease：

Posterior Cruciate Ligament(PCL)Tibial Avulsion Fractures

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：

主要目的：比较机器人手术治疗后交叉韧带胫骨止点撕脱骨折的有效性。 1. 骨折术后复位解剖效果评价：测量术后CT（术后3天（前后+/-24小时））的矢状位骨块分离所在最大层面距离：优＜2mm；2mm<=良<=5mm；差＞5mm 次要目的： 1. 综合功能效果评价：比较（传统内固定组与机器人手术组）患者在术后不同时间点（6周（前后+/-1周），12周（前后+/-2周）、24周（前后+/-2周）、1年（前后+/-1个月））的膝关节功能评分（IKDC主观评分等）。 2.比较各组患者术后骨折愈合时间、术后12周（前后+/-1周）、24周（前后+/-2周）的膝关节活动度（ROM）。 3.评估各组手术的相关指标：手术时间、术中透视次数、术中失血量、并发症发生率（如感染、神经血管损伤、内固定失效、骨折不愈合、再次手术等）。

Objectives of Study：

Primary Objective: To evaluate and compare the efficacy of robotic-assisted surgery versus conventional open surgery in the management of tibial insertion avulsion fractures of the cruciate ligaments. Secondary Objectives: 1. To assess postoperative anatomical reduction quality by quantifying the maximum sagittal-plane separation distance of the avulsed bony fragment on postoperative computed tomography (CT) scans acquired within 72 hours (+/-24 hours) after surgery, with predefined criteria: excellent (<=2 mm), good (>2 mm to <=5 mm), and poor (>5 mm). 2. To compare longitudinal functional outcomes between the robotic-assisted and conventional internal fixation groups, including validated patient-reported and clinician-assessed knee function scores—specifically the International Knee Documentation Committee (IKDC) subjective score—at prespecified time points: 6 weeks (+/-1 week), 12 weeks (+/-2 weeks), 24 weeks (+/-2 weeks), and 12 months (+/-1 month) postoperatively. 3. To compare radiographic fracture healing time, knee joint range of motion (ROM) at 12 weeks (+/-1 week) and 24 weeks (+/-2 weeks) postoperatively, and key intraoperative and perioperative metrics—including operative duration, number of intraoperative fluoroscopic images, estimated blood loss, and incidence of adverse events (e.g., surgical site infection, neurovascular injury, implant failure, nonunion, or reoperation). Modification Points: 1. Replaced informal phrasing ("Main objective", "To compare the effectiveness of robotic surgery in treating…") with formal academic terminology ("Primary Objective", "to evaluate and compare the efficacy of robotic-assisted surgery versus conventional open surgery in the management of…"), enhancing precision, neutrality, and alignment with clinical trial reporting standards (e.g., CONSORT, SPIRIT). 2. Clarified the comparator group explicitly ("versus conventional open surgery") to avoid ambiguity—original text omitted the control group name, undermining methodological transparency. 3. Revised the anatomical assessment description for technical accuracy and consistency: specified "sagittal-plane separation distance of the avulsed bony fragment" (instead of vague "sagittal bone block separation"), clarified timing as "within 72 hours (+/-24 hours)", and standardized categorical definitions using inclusive/exclusive inequalities (e.g., ">2 mm to <=5 mm") to eliminate interpretive ambiguity present in the original "2mm <= good <= 5mm". 4. Upgraded terminology across secondary objectives: replaced colloquial or imprecise terms (e.g., "Comprehensive functional outcome evaluation" → "To compare longitudinal functional outcomes"; "traditional internal fixation group" → "conventional internal fixation groups"; "knee joint function scores (IKDC subjective scores, etc.)" → "validated patient-reported and clinician-assessed knee function scores—specifically the International Knee Documentation Committee (IKDC) subjective score") to reflect rigorous outcome measurement conventions. 5. Standardized temporal descriptors using consistent, academically preferred phrasing ("at prespecified time points", "postoperatively", "within 72 hours (+/-24 hours)") instead of fragmented constructions like "before and after +/- X". 6. Improved parallel structure and grammatical completeness across all listed objectives (e.g., all items now begin with infinitive verbs—"To assess…", "To compare…", "To compare…"—ensuring syntactic cohesion and readability in formal protocols or manuscripts). 7. Expanded and precisely defined adverse events using clinically accepted terminology (e.g., "surgical site infection" instead of "infection", "implant failure" instead of "failure of internal fixation") while retaining all original safety endpoints without omission or semantic drift. 8. Ensured consistent use of units, punctuation, and capitalization (e.g., "CT" not "computed tomography" in parentheses after first use; "mm" in lowercase; en dashes for ranges) per scientific writing conventions.

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. 病理性骨折或合并同侧其他部位骨折等复杂损伤。 2. 既往有同侧膝关节手术史。 3. 合并重要血管神经损伤者。 4. 合并急性半月板损伤、急性前交叉韧带及内外侧副韧带损伤者。 5. 局部软组织条件不良，包括存在皮肤开放伤口、开放骨折

Exclusion criteria：

1. Pathological fractures or complex ipsilateral injuries involving additional skeletal sites. 2. Prior ipsilateral knee arthroplasty or other major knee joint surgery. 3. Presence of clinically significant vascular or neurological compromise. 4. Acute concomitant intra-articular injuries, including meniscal tears, anterior cruciate ligament (ACL) rupture, and medial or lateral collateral ligament (MCL/LCL) injuries. 5. Compromised local soft tissue integrity, such as open skin wounds or open fractures.

研究实施时间：

Study execute time：

从 From 2026-03-26 00:00:00至 To 2030-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-04-13 00:00:00 至 To 2030-12-31 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	11
Group：	Trial Group	Sample size：	11
干预措施：	机器人辅助手术：安装示踪器规划并行形成骨道，缝合钩固定韧带，屈膝位复位并固定，术中影像确认。	干预措施代码：
Intervention：	Robotic-assisted surgery: Tracer installation for planning and creating bone tunnels, suture hook fixation of ligament, reduction and fixation in flexion position, intraoperative imaging confirmation.	Intervention code：

组别：	对照组	样本量：	11
Group：	Control Group	Sample size：	11
干预措施：	传统切开复位内固定：俯卧位，后侧入路，显露骨折处，清理血肿，复位并固定，术中影像确认。	干预措施代码：
Intervention：	Traditional open reduction and internal fixation: Prone position, posterior approach, exposure of fracture site, hematoma debridement, reduction and fixation, intraoperative imaging confirmation.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	北京	市(区县)：	北京
Country：	China	Province：	Beijing	City：	Beijing
单位(医院)：	北京清华长庚医院	单位级别：	三级
Institution hospital：	Beijing Tsinghua Changgung Hospital	Level of the institution：	Tertiary

国家：	中国	省(直辖市)：	河北	市(区县)：	石家庄
Country：	China	Province：	Hebei	City：	Shijiazhuang
单位(医院)：	石家庄市第三医院	单位级别：	三级
Institution hospital：	Shijiazhuang Third Hospital	Level of the institution：	Tertiary

国家：	中国	省(直辖市)：	河南	市(区县)：	南阳
Country：	China	Province：	Henan	City：	Nanyang
单位(医院)：	南阳市骨科医院	单位级别：	三甲
Institution hospital：	Nanyang Orthopedic Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	骨折术后复位解剖效果（矢状位骨块分离所在最大层面距离）	指标类型：	主要指标
Outcome：	Anatomical reduction efficacy after fracture surgery (maximum distance of bone fragment separation in the sagittal plane)	Type：	Primary indicator
测量时间点：	术后 3 天	测量方法：
Measure time point of outcome：	Postoperative day 3	Measure method：

指标中文名：	膝关节功能评分（IKDC 主观评分）	指标类型：	次要指标
Outcome：	Knee function score (IKDC subjective assessment)	Type：	Secondary indicator
测量时间点：	术后 6 周、12 周、24 周、1 年	测量方法：
Measure time point of outcome：	6 weeks, 12 weeks, 24 weeks, 1 year postoperatively	Measure method：

指标中文名：	膝关节活动度（ROM）	指标类型：	次要指标
Outcome：	Range of motion (ROM) of the knee joint	Type：	Secondary indicator
测量时间点：	术后 12 周、24 周	测量方法：
Measure time point of outcome：	12 weeks, 24 weeks postoperatively	Measure method：

指标中文名：	术后骨折愈合时间	指标类型：	次要指标
Outcome：	Time to fracture healing postoperatively	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	手术相关指标	指标类型：	次要指标
Outcome：	Surgical-related indicators	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	医疗成本	指标类型：	次要指标
Outcome：	Medical cost	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	安全性指标（包括：并发症发生率（感染、神经血管损伤、内固定失效、骨折不愈合、再次手术等）、术中失血量、术中透视次数、不良事件）	指标类型：	副作用指标
Outcome：	Safety outcomes (including incidence of complications such as infection, nerve/vessel injury, implant failure, nonunion, reoperation, intraoperative blood loss, number of fluoroscopies, and adverse events)	Type：	Adverse events
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：

标本中文名：	无	组织：	无
Sample Name：	None	Tissue：	None
人体标本去向	其它	说明	无
Fate of sample：	0thers	Note：	None

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	18	岁 years
最大 Max age	NA	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）：

中央随机化，使用计算机生成的随机数字表

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

Centralized randomization was performed using a computer-generated random number table

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：	各中心均操作一致，其中医生知道分组情况，但患者不知情
Blinding：	All participating centers adhered to a standardized operational protocol. While clinicians were aware of the treatment group assignments, participants remained blinded to their allocation.
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	是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）：	试验结束后12个月内原始数据将仅提供给合作研究团队，并在试验结束后由研究者经脱敏处理后通过安全数据传输方式共享。数据使用须获得研究负责人同意并经伦理委员会批准，并仅限科研用途
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	The original dataset will be made available to the collaborating research team no later than 12 months following the completion of the clinical trial. Subsequently, de-identified data will be shared via a secure, encrypted transmission protocol. Any use of the data is strictly contingent upon prior written approval from the principal investigator and formal authorization by the institutional ethics review board, and shall be limited exclusively to peer-reviewed scientific research activities.
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：	数据采集采用电子病例报告表（eCRF）方式，研究者在入组、随访及终点评估时记录各项临床指标。所有数据均由经过培训的研究人员录入电子数据管理系统（EDC），系统符合 21 CFR Part 11 要求，支持审计追踪。数据录入后进行自动一致性检查和逻辑校验，异常值由数据管理员核实。所有数据均进行脱敏处理，受试者隐私通过编码保护。数据库访问权限分级，仅授权人员可访问相关数据，并定期进行备份以保证数据安全。整个数据采集与管理过程遵循 ICH-GCP 指南及本研究中心相关法规和伦理要求。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Data collection was performed using validated electronic case report forms (eCRFs). Clinical assessments—including baseline enrollment, scheduled follow-up visits, and endpoint evaluations—were systematically documented by trained investigators. All data were entered into a 21 CFR Part 11–compliant electronic data capture (EDC) system, which maintains comprehensive audit trails and supports role-based access control. Following data entry, automated edit checks—including range, consistency, and logical validations—were executed; discrepancies and outliers underwent source-data verification by the designated Data Manager. To safeguard participant confidentiality, all personally identifiable information was removed prior to database lock, and subjects were assigned unique anonymized identifiers. Database access was strictly governed by predefined permission levels, restricting data visibility to authorized personnel only. Robust data security measures—including encrypted storage, scheduled offsite backups, and periodic system integrity audits—were implemented throughout the study. The entire data lifecycle—from collection and entry to validation, anonymization, and archival—was conducted in full compliance with the International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines, applicable national regulatory requirements, and the institutional ethics framework governing this study.
数据与安全监察委员会： Data and Safety Monitoring Committee：	暂未确定/Not yet
注册人： Name of Registration：	2026-04-11 22:18:07