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：	ChiCTR2600125330
最近更新日期： Date of Last Refreshed on：	2026-05-25 17:34:17
注册时间： Date of Registration：	2026-05-25 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	动态超声观察髋关节撞击综合征发病机制的可行性研究
Public title：	Feasibility Study on Dynamic Ultrasound Observation of the Pathogenesis of Hip Impingement Syndrome
注册题目简写：
English Acronym：
研究课题的正式科学名称：	动态超声观察髋关节撞击综合征发病机制的可行性研究
Scientific title：	Feasibility Study on Dynamic Ultrasound Observation of the Pathogenesis of Hip Impingement Syndrome
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：	曾曾	研究负责人：	林剑浩
Applicant：	Zeng Zeng	Study leader：	Lin Jianhao
申请注册联系人电话： Applicant telephone：	+86 188 1118 6853	研究负责人电话： Study leader's telephone：	+86 10 8832 6666
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：	verazeng@stu.pku.edu.cn	研究负责人电子邮件： Study leader's E-mail：	linjianhao@pkuph.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：	西直门南大街11号北京大学人民医院	研究负责人通讯地址：	西直门南大街11号北京大学人民医院
Applicant address：	No.11 Xizhimen South Street, Xicheng District, Beijing, P.R.China	Study leader's address：	No.11 Xizhimen South Street, Xicheng District, Beijing, P.R.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：	北京大学人民医院
Applicant's institution：	Peking University People's Hospital‌
研究负责人所在单位：	北京大学人民医院
Affiliation of the Leader：	Peking University 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：	2026PHB337-001	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：	北京大学人民医院伦理审查委员会第二组
Name of the ethic committee：	Ethics Review Committee of Peking University People's Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2026-04-29 00:00:00
伦理委员会联系人：	丛翠翠
Contact Name of the ethic committee：	Cong CuiCui
伦理委员会联系地址：	西直门南大街11号北京大学人民医院
Contact Address of the ethic committee：	No.11 Xizhimen South Street, Xicheng District, Beijing, P.R.China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 10 8832 4516	伦理委员会联系人邮箱： Contact email of the ethic committee：	llwyh4516@163.com

研究实施负责（组长）单位：

北京大学人民医院

Primary sponsor：

Peking University People's Hospital

研究实施负责（组长）单位地址：

西直门南大街11号北京大学人民医院

Primary sponsor's address：

No.11 Xizhimen South Street, Xicheng District, Beijing, P.R.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	市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	北京大学人民医院	具体地址：	西直门南大街11号北京大学人民医院
Institution hospital：	Peking University People's Hospital	Address：	No.11 Xizhimen South Street, Xicheng District, Beijing, P.R.China

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-funded research project

研究疾病：

本研究的具体疾病为以慢性腹股沟区髋痛为主要症状的髋关节疼痛综合征，患者表现为持续3个月以上的腹股沟区疼痛及髋关节功能障碍，在FADIR动作、HEC试验及改良Thomas试验等标准化诱发体位下症状可被诱发或加重。研究对象的潜在病因考虑髋关节撞击综合征或髂腰肌撞击综合征，两者均可导致髋臼盂唇损伤，若未及时干预可进展为早发性髋关节骨关节炎。

Target disease：

The specific disease investigated in this study is hip pain syndrome characterized primarily by chronic groin pain, in which patients present with groin pain and hip functional impairment lasting more than 3 months, with symptoms reproducible or exacerbated under standardized provocative maneuvers including the FADIR maneuver, HEC test, and modified Thomas test. The underlying etiology in the stud

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：

其它

Study phase：

N/A

研究设计：

横断面

Study design：

Cross-sectional

研究目的：

本研究为横断面观察性可行性研究，旨在探索动态超声实时成像结合光学动态捕捉技术观察髋关节撞击综合征发病机制的可行性。招募髋痛患者30例及健康对照20例，对每例受试者分别行改良Thomas体位、HEC试验体位及FADIR动作下的动态超声检查，同步采集探头六自由度位姿数据。主要指标为髂腰肌腱-盂唇间距变化（Δd）、接触征象及盂唇形变。后处理阶段完成视频抽帧、盂唇图像标注（目标各≥500帧）、AI分割模型训练及超声图像三维重建；对有MRI资料的患者，进一步将超声三维重建结果与MRI三维重建图像进行配准对比，评估超声重建对盂唇解剖形态的还原精度。统计方法采用独立样本t检验、卡方检验及一致性分析，比较患者组与对照组差异，评估方法学可行性。

Objectives of Study：

This study is a cross-sectional observational feasibility study aiming to explore the feasibility of using dynamic ultrasound real-time imaging combined with optical dynamic capture technology to observe the pathogenesis of hip impingement syndrome. Thirty patients with hip pain and 20 healthy controls were recruited. Each subject underwent dynamic ultrasound examinations under the modified Thomas position, HEC test position, and FADIR maneuver, with simultaneous collection of six-degree-of-freedom pose data of the probe. The primary outcomes were changes in iliopsoas tendon-labral distance (Δd), contact signs, and labral deformation. During the post-processing stage, video frame extraction, labral image annotation (with each target ≥500 frames), AI segmentation model training, and three-dimensional reconstruction of ultrasound images were completed; for patients with MRI data, the three-dimensional reconstruction results of ultrasound were further registered and compared with MRI three-dimensional reconstruction images to evaluate the accuracy of ultrasound reconstruction in restoring the anatomical morphology of the labrum. Statistical methods including independent samples t-test, chi-square test, and consistency analysis were used to compare the differences between the patient group and the control group and to evaluate the methodological feasibility.

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. 明确器质性髋关节疾病： (1) 患侧髋关节手术史； (2) 近6个月内急性创伤性髋关节损伤； (3) 严重骨关节炎（Toennis分级>=2级）； (4) 髋关节发育不良（CE角<20°，X线确认）； (5) 股骨头缺血性坏死（X线/MRI/骨扫描确认）； (6) 类风湿关节炎、强直性脊柱炎、痛风性关节炎等炎性关节病。 2. 腰椎/神经源性鉴别： (1) 腰椎间盘突出伴明确下肢放射痛（L2～L4皮节分布）； (2) 临床判断腹股沟区疼痛主要来源于腰椎（直腿抬高试验+Kemp试验>=2项阳性且髋关节体征均阴性）。 3. 影响检查质量： (1) 近6个月内患侧髋关节腔内或髂腰肌腱鞘内注射（糖皮质激素/透明质酸/局麻药）； (2) 预备动作测试中腹股沟区图像质量预评为3级（差）； (3) 腹股沟区皮肤破损或感染； (4) 妊娠/哺乳期； (5) 未通过预备动作测试； (6) 拒绝签署知情同意书。

Exclusion criteria：

1. Identify organic hip joint diseases: (1) surgical history of the affected hip joint; (2) acute traumatic hip joint injury within the past 6 months; (3) severe osteoarthritis (Toennis grade >=2); (4) hip dysplasia (CE angle <20°, confirmed by X-ray); (5) ischemic necrosis of the femoral head (confirmed by X-ray/MRI/bone scan); (6) inflammatory joint diseases such as rheumatoid arthritis, ankylosing spondylitis, and gouty arthritis. 2. Lumbar spine/neurogenic differentiation: (1) lumbar disc herniation with clear lower limb radiating pain (distribution of L2-L4 dermatomes); (2) Clinical judgment shows that the pain in the inguinal area mainly comes from the lumbar spine (with >=2 positive results in the straight leg elevation test and Kemp test, and negative hip joint signs). 3. Impact on examination quality: (1) Injection of corticosteroids/hyaluronic acid/local anesthetics into the affected hip joint cavity or iliopsoas tendon sheath within the past 6 months; (2) The pre-evaluation of the image quality of the groin area in the preparatory movement test is rated as level 3 (poor); (3) Skin damage or infection in the inguinal region; (4) Pregnancy/lactation period; (5) Failed to pass the preparatory action test; (6) Refusal to sign informed consent form.

研究实施时间：

Study execute time：

从 From 2026-03-25 00:00:00至 To 2027-07-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-05-25 00:00:00 至 To 2027-07-01 00:00:00

干预措施：

Interventions：

组别：	髋痛患者组	样本量：	30
Group：	Hip Pain Patient Group	Sample size：	30
干预措施：	髋关节疼痛	干预措施代码：
Intervention：	Hip Pain	Intervention code：

组别：	健康对照组	样本量：	20
Group：	Healthy control group	Sample size：	20
干预措施：	无	干预措施代码：
Intervention：	None	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	市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	北京大学人民医院	单位级别：	三级甲等
Institution hospital：	Peking University People's Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	AI盂唇分割性能（AUC）	指标类型：	次要指标
Outcome：	AI labrum segmentation performance (AUC)	Type：	Secondary indicator
测量时间点：	AI模型训练完成后	测量方法：	以人工标注结果为金标准，评估模型对盂唇区域自动分割的AUC
Measure time point of outcome：	After the completion of AI model training	Measure method：	Using manually annotated results as the gold standard, evaluate the AUC of the model for automatic segmentation of the labrum region

指标中文名：	MRI配准精度	指标类型：	次要指标
Outcome：	MRI registration accuracy	Type：	Secondary indicator
测量时间点：	超声三维重建与MRI三维重建完成后	测量方法：	采用刚体配准方法计算Dice系数及Hausdorff距离
Measure time point of outcome：	After the completion of ultrasound 3D reconstruction and MRI 3D reconstruction	Measure method：	Using rigid body registration method to calculate Dice coefficient and Hausdorff distance

指标中文名：	髂腰肌腱-盂唇间距变化值（Δd）	指标类型：	主要指标
Outcome：	Changes in distance between iliopsoas tendon and labrum (Δ d)	Type：	Primary indicator
测量时间点：	三种标准化诱发体位（改良Thomas体位、HEC试验体位、FADIR动作）检查时	测量方法：	动态超声下由超声医师A手动测量静息位与最大诱发位的肌腱-盂唇间距差值，超声医师B独立复测，取两者均值，精度±1mm
Measure time point of outcome：	When examining three standardized induction positions (modified Thomas position, HEC test position,	Measure method：	Under dynamic ultrasound, ultrasound physician A manually measures the difference in tendon labrum distance between the resting position and the maximum evoked position. Ultrasound physician B independently retests and takes the average of the two with an accuracy of ± 1mm

指标中文名：	三维重建可行率	指标类型：	次要指标
Outcome：	Feasibility rate of 3D reconstruction	Type：	Secondary indicator
测量时间点：	全部50例现场采集完成后	测量方法：	统计动捕数据质量合格且成功完成超声图像三维重建的受试者比例
Measure time point of outcome：	After on-site collection is completed	Measure method：	Proportion of subjects with qualified quality of motion capture data and successful completion of 3D reconstruction of ultrasound images

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	18	岁 years
最大 Max age	60	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)：

No

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）：	本研究原始数据涉及受试者个人健康信息及影像资料，出于隐私保护及数据安全考虑，原始数据不对外共享。
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	The raw data generated in this study are not publicly available due to privacy and confidentiality restrictions, as they contain personal health information and imaging data of study participants.
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.病例报告表及数据库设计研究启动前统一设计纸质版病例报告表（CRF），涵盖受试者基本信息、预备动作测试结果、体征检查记录、超声测量数值（Δd）及接触征象/盂唇形变判读结论等全部数据字段。同步建立电子数据库（Excel或REDCap），字段设计与CRF保持一致，所有字段设置合理值域范围及逻辑核查规则。受试者以研究编号（如P001～P050）代替姓名，编号与身份信息的对应表单独加密保存，仅课题负责人持有。 2.数据采集与录入现场采集阶段，超声视频与动捕数据实时导出至加密服务器，按“受试者编号-检查日期-体位编号”规则归档，采集当日完成归档核查。纸质CRF由操作员于检查结束后当日填写完毕，48小时内由第二人将CRF数据双录入电子数据库，以核查录入一致性。 3.数据核查与审核每完成10例，由课题负责人对已录入数据进行一次阶段性核查，内容包括：字段完整性核查（是否存在缺失值）、逻辑一致性核查（如排除标准与入组记录是否矛盾）及超声视频与CRF记录的一致性抽查。超声医师B的盲法复评结论于24小时内录入独立评估表，与医师A的结论分开保存，直至全部采集完成后方可合并比较，以保障盲态完整性。 4.数据库锁定全部50例现场采集完成、所有CRF数据录入核查无误、盲法复评及事后影像学分型均完成后，由课题负责人确认数据库完整性并正式锁定，锁定后不再进行任何修改。如需更正，须填写数据更正记录表并注明原因及操作人员信息。 5.数据导出、传输与归档统计分析数据集由课题负责人从锁定数据库中导出，以加密方式传输至统计分析人员。后处理所需图像数据（PNG帧序列及对应时间戳文件）通过加密存储介质传输，传输前后均核查文件完整性（MD5校验）。对有MRI资料的患者，其原始MRI影像数据由临床研究者统一导出并脱敏处理，以加密方式归档保存，用于后续超声-MRI三维配准分析。研究完成后，全部原始数据（超声视频、动捕数据、CRF、电子数据库、标注文件）在加密服务器及备份硬盘中保存不少于5年，保存期满后按规定销毁。受试者身份识别信息与研究数据全程分离保存，研究成果发表时不披露任何可识别个人身份的信息。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	1. Case Report Form and Database DesignBefore the start of the study, a unified paper-based Case Report Form (CRF) was designed, covering all data fields such as the subject's basic information, pre-action test results, physical examination records, ultrasound measurement values (Δd), and interpretation conclusions of contact signs/ labral deformation. An electronic database (Excel or REDCap) was simultaneously established, with field design consistent with the CRF, and all fields were set with reasonable value ranges and logical verification rules. Subjects were identified by study numbers (e.g., P001 - P050) instead of names, and the correspondence table between numbers and identity information was separately encrypted and stored, accessible only to the project leader.2. Data Acquisition and EntryDuring the on-site data acquisition phase, ultrasound videos and motion capture data are exported in real time to an encrypted server, archived according to the rule of "subject number - examination date - position number", and the archiving verification is completed on the day of acquisition. The paper CRF is filled out by the operator on the day after the examination is completed, and within 48 hours, a second person double-enters the CRF data into the electronic database to verify the consistency of the entry. 3. Data Verification and ReviewAfter every 10 cases are completed, the project leader shall conduct a phased review of the entered data, including: field completeness review (whether there are missing values), logical consistency review (such as whether the exclusion criteria contradict the enrollment records), and spot checks on the consistency between ultrasound videos and CRF records. The blind reevaluation conclusion of Ultrasound Physician B shall be entered into the independent evaluation form within 24 hours, stored separately from Physician A's conclusion, and only merged and compared after all data acquisition is completed to ensure the integrity of the blind state. 4. Database LockingAfter all 50 cases of on-site Data Acquisition are completed, all CRF data entry is verified without errors, blind reevaluation and post hoc imaging classification are all completed, the project leader shall confirm the integrity of the database and officially lock it. No further modifications will be made after locking. If corrections are needed, a Data Correction Record Form must be filled out, indicating the reason and operator information. 5. Data Export, Transmission, and ArchivingThe statistical analysis dataset is exported from the locked database by the project leader and transmitted to the statistical analyst in an encrypted manner. The image data required for post-processing (PNG frame sequences and corresponding timestamp files) is transmitted via encrypted storage media, with file integrity verified (MD5 check) both before and after transmission. For patients with MRI data, the original MRI image data is uniformly exported and desensitized by the clinical researcher, then archived and stored in an encrypted manner for subsequent ultrasound-MRI three-dimensional registration analysis. After the study is completed, all original data (ultrasound videos, motion capture data, CRF, electronic databases, annotation files) will be stored in encrypted servers and backup hard drives for no less than 5 years, and will be destroyed as required after the storage period expires. The subject's identification information and research data are stored separately throughout the process, and no personally identifiable information will be disclosed when the research results are published.
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2026-05-25 17:34:12