ChiCTR2600125374 版本V1.0 版本创建时间2026/05/26 11:30:17 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2600125374 

最近更新日期：

Date of Last Refreshed on：

2026-05-26 11:30:00 

注册时间：

Date of Registration：

2026-05-26 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

脊柱畸形多模态外观评估体系的建立和验证：基于三维立体摄影的体表形态量化与人工智能应用研究

Public title：

Development and Validation of a Multimodal Appearance Assessment System for Spinal Deformity: 3D Stereophotogrammetry–Based Surface Morphometrics and Artificial Intelligence Applications

注册题目简写：

脊柱畸形外观研究

English Acronym：

SCOPE study

研究课题的正式科学名称：

脊柱畸形多模态外观评估体系的建立和验证：基于三维立体摄影的体表形态量化与人工智能应用研究

Scientific title：

Development and Validation of a Multimodal Appearance Assessment System for Spinal Deformity: 3D Stereophotogrammetry–Based Surface Morphometrics and Artificial Intelligence Applications

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：

白卓松 

研究负责人：

王升儒 

Applicant：

Zhuosong Bai 

Study leader：

Shengru Wang 

申请注册联系人电话：

Applicant telephone：

+86 10 6915 2700

研究负责人电话：

Study leader's telephone：

+86 10 6915 2701

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：

baizhuosong@126.com

研究负责人电子邮件：

Study leader's E-mail：

wangshengru@foxmail.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：

北京市东城区帅府园1号

研究负责人通讯地址：

北京市东城区帅府园1号

Applicant address：

1st Shuaifuyuan, Dongcheng District, Beijing 100730, China.

Study leader's address：

1st Shuaifuyuan, Dongcheng District, Beijing 100730, China.

申请注册联系人邮政编码：

Applicant postcode：

100730

研究负责人邮政编码：

Study leader's postcode：

100730

申请人所在单位：

中国医学科学院北京协和医院

Applicant's institution：

Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences

研究负责人所在单位：

中国医学科学院北京协和医院

Affiliation of the Leader：

Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

I-26PJ0958

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：

中国医学科学院北京协和医院伦理审查委员会

Name of the ethic committee：

Ethics Review Committee of Peking Union Medical College and Chinese Academy of Medical Sciences

伦理委员会批准日期：

Date of approved by ethic committee：

2026-04-21 00:00:00

伦理委员会联系人：

李佳月

Contact Name of the ethic committee：

Jiayue Li

伦理委员会联系地址：

北京市东城区帅府园1号

Contact Address of the ethic committee：

1st Shuaifuyuan, Dongcheng District, Beijing 100730, China.

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10 6915 6874

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：

中国医学科学院北京协和医院骨科

Primary sponsor：

Department of Orthopedic Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences

研究实施负责（组长）单位地址：

北京市东城区帅府园1号

Primary sponsor's address：

1st Shuaifuyuan, Dongcheng District, Beijing 100730, 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)：

东城区

Country：

China

Province：

Beijing

City：

Beijing

单位(医院)：

中国医学科学院北京协和医院

具体地址：

北京市东城区帅府园1号

Institution
hospital：

Peking Union Medical College Hospital

Address：

1st Shuaifuyuan, Dongcheng District, Beijing 100730, China.

经费或物资来源：

国家重点研发计划：脊柱畸形精准诊疗体系构建及关键技术研究

Source(s) of funding：

National Key Research and Development Program of China

Target disease：

Spinal deformity

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：

连续入组 

Study design：

Sequential 

研究目的：

本研究旨在建立并验证一个以三维体表立体摄影为核心的脊柱畸形外观客观化评估平台，在统一的前瞻性队列基础上整合三维体表点云/网格信息、标准化二维摄影、脊柱影像学参数与患者报告结局（PROMs），构建可重复、可解释、可推广的客观化外观评估体系，并进一步开发基于体表三维重建的脊柱序列预测人工智能模型，实现免辐射或低辐射的脊柱畸形评估、风险分层与疗效预测，最终服务于以患者为中心的临床决策、术前沟通与随访管理。  

Objectives of Study：

This study aims to establish and validate an objective evaluation platform for spinal deformities based on three-dimensional body surface stereoscopic photography. On the basis of a unified prospective cohort, it integrates three-dimensional body surface point cloud/grid information, standardized two-dimensional photography, spinal imaging parameters, and patient-reported outcomes (PROMs), to construct a repeatable, interpretable, and scalable objective evaluation system. Furthermore, it develops an artificial intelligence model for predicting spinal sequences based on three-dimensional body surface reconstruction, enabling non-radiation or low-radiation assessment, risk stratification, and efficacy prediction of spinal deformities. Ultimately, it serves as a basis for patient-centered clinical decision-making, preoperative communication, and follow-up management.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

脊柱畸形患者队列： 1.不限性别 2.年龄 8-50 岁； 3.临床诊断为以下之一： ? 青少年特发性脊柱侧凸（AIS）； ? 成人脊柱畸形（ASD，包括退变性/特发性成人侧凸等）； ? 先天性脊柱畸形（如半椎体、分节障碍等）； ? 综合征性脊柱畸形（如 NF1、Marfan 等，基于临床或遗传学诊断）； 4.能够配合完成至少背部/躯干的标准化 3D 体表扫描及问卷采集；二维临床大体照及面部/乳房相关采集按模块化同意实施，受试者可选择退出特定摄影模块而不影响其余研究流程； 5.能够配合完成标准化 3D 体表扫描、2D临床大体照拍摄及问卷采集； 6.同意研究数据的去标识化存储与分析，并签署知情同意书； 7.具备可用于研究目的的常规临床影像学资料（如全脊柱 X 线、CT等）。 8.若拟行脊柱畸形矫正手术，承诺参加所有计划的随访。 对照组受试者（健康受试者/非脊柱畸形人群） 1.年龄 8-50 岁； 2.无临床明确脊柱畸形史、无已知中重度躯干不对称体征； 3.能够配合完成至少背部/躯干的标准化 3D 体表扫描及问卷采集；二维临床大体照及面部/乳房相关采集按模块化同意实施，受试者可选择退出特定摄影模块而不影响其余研究流程； 4.同意研究数据的去标识化存储与分析，并签署知情同意书。 说明：针对因隐私顾虑导致的模块参与差异（例如女性受试者对面部/乳房采集的选择性退出），研究将系统评估潜在选择偏倚：比较“完成 vs 未完成”特定模块采集的受试者在性别、年龄、BMI、弯型与严重度等基线特征上的差异，并在必要时采用多重插补（multiple imputation）或逆概率加权（inverse probability weighting）进行敏感性分析，以评估该偏倚对主要结论的影响。

Inclusion criteria

Cohort of patients with spinal deformities: 1. No gender restrictions 2. Age 8 - 50 years old 3. Clinically diagnosed with one of the following: ? Juvenile Idiopathic Scoliosis (AIS) ? Adult Spinal Deformity (ASD, including degenerative/idiopathic adult scoliosis, etc.) ? Congenital Spinal Deformity (such as hemivertebra, segmentation disorder, etc.) ? Syndromic Spinal Deformity (such as NF1, Marfan, etc., based on clinical or genetic diagnosis) 4. Able to cooperate and complete at least standardized 3D surface scans of the back/trunk and questionnaire collection; two-dimensional clinical general radiographs and facial/mastoid-related collection are implemented according to modular consent, and subjects can choose to exit specific photography modules without affecting the rest of the research process 5. Able to cooperate and complete standardized 3D surface scans, 2D clinical general radiographs, and questionnaire collection 6. Agree to the de-identification storage and analysis of research data and sign the informed consent form 7. Have conventional clinical imaging data (such as full spine X-rays, CT, etc.) that can be used for research purposes 8. If undergoing spinal deformity correction surgery, promise to participate in all planned follow-ups Control group subjects (healthy subjects/non-spinal deformity population) 1. Age 8 - 50 years old 2. No clinical history of definite spinal deformity, no known moderate to severe trunk asymmetry signs 3. Able to cooperate and complete at least standardized 3D surface scans of the back/trunk and questionnaire collection; two-dimensional clinical general radiographs and facial/mastoid-related collection are implemented according to modular consent, and subjects can choose to exit specific photography modules without affecting the rest of the research process 4. Agree to the de-identification storage and analysis of research data and sign the informed consent form. Note: To address the module participation differences due to privacy concerns (such as female subjects' selective withdrawal from facial/mastoid collection), the study will systematically assess potential selection bias: compare the differences in baseline characteristics such as gender, age, BMI, curvature and severity between "completed vs. uncompleted" specific module collections, and conduct sensitivity analysis using multiple imputation or inverse probability weighting when necessary to evaluate the impact of this bias on the main conclusions.

排除标准：

1.无法安全或稳定保持标准化站立位完成采集（例如严重眩晕、无法站立、严重神经系统功能障碍导致明显跌倒风险）； 2.关键采集区域存在无法避免的遮挡因素或严重皮肤问题导致采集失败（大面积敷料、严重皮损/感染等；可延期重新采集者不视为排除）； 3.除脊柱畸形矫正手术外的既往躯干手术史，如涉及乳房、胸部、腹部、腰背部及双下肢； 4.明确拒绝任何形式的摄影/3D 采集（若仅拒绝乳房或面部采集，可作为模块退出而非整体排除）； 5.研究者判断存在显著心理不适或其他原因导致不宜参与外观相关采集者； 6.不能完成随访； 7.患有严重的系统性疾病或精神性疾病。

Exclusion criteria：

1. Unable to safely or stably maintain the standardized standing position to complete the collection (such as severe vertigo, inability to stand, severe neurological dysfunction resulting in a significant risk of falling); 2. There are unavoidable obstructions or severe skin problems in the key collection area that lead to collection failure (large dressings, severe skin lesions/infections, etc.; those who can be postponed for re-collection are not considered excluded); 3. Previous history of trunk surgeries other than spinal deformity correction surgery, such as those involving the breasts, chest, abdomen, lower back, and both lower limbs; 4. Clearly refuse any form of photography/3D collection (if only refusing collection of the breasts or face, it can be regarded as module exit rather than overall exclusion); 5. The researcher determines that there is significant psychological discomfort or other reasons that make it inappropriate to participate in appearance-related collection; 6. Unable to complete follow-up; 7. Suffering from severe systemic diseases or mental disorders.

研究实施时间：

Study execute time：

从 From 2026-05-01 00:00:00至 To 2028-05-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-06-01 00:00:00 至 To 2028-05-01 00:00:00  

干预措施：

Interventions：

组别：

脊柱畸形组

样本量：

1000

Group：

Spinal deformity group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

组别：

对照组

样本量：

250

Group：

Control group

Sample size：

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(区县)：

 东城区 

Country：

China 

Province：

Beijing 

City：

Dongcheng 

单位(医院)：

中国医学科学院北京协和医院 

单位级别：

三级甲等 

Institution
hospital：

Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

信度

指标类型：

主要指标

Outcome：

reliability

Type：

Primary indicator

测量时间点：

T0：术前；T1：术后1周；术后3个月；T2：术后 12个月；T3：术后 24个月

测量方法：

对关键 3D 指标与综合评分（如 SDI/子域评分）评估 test–retest reliability（ICC），并计算 SEM、MDC；对重复测量采用 Bland–Altman 方法评估一致性与系统偏倚

Measure time point of outcome：

T0: Before the operation; T1: One week after the operation; Three months after the operation; T2: Twelve months after the operation; T3: Twenty-four months after the operation

Measure method：

Evaluate the test-retest reliability of key 3D indicators and comprehensive scores (such as SDI/sub-domain scores) by assessing them, and calculate SEM and MDC; Use the Bland–Altman method to evaluate the consistency and systematic bias for repeated measurements

指标中文名：

效度

指标类型：

主要指标

Outcome：

validity

Type：

Primary indicator

测量时间点：

T0：术前；T1：术后1周；术后3个月；T2：术后 12个月；T3：术后 24个月

测量方法：

开展结构效度（因子分析/降维）、收敛效度（与外观相关 PROMs 的相关性）、区分效度（与非外观领域 PROMs 的低相关性）、已知组效度（known-groups validity：不同严重度/弯型或患者 vs 健康对照的差异）

Measure time point of outcome：

T0: Before the operation; T1: One week after the operation; Three months after the operation; T2: Twelve months after the operation; T3: Twenty-four months after the operation

Measure method：

Carry out structural validity (factor analysis/dimension reduction), convergent validity (correlation with appearance-related PROMs), discriminant validity (low correlation with PROMs in non-appearance domains), and known-groups validity (known-groups validity: differences between different severity/curvature or patients vs healthy controls)

指标中文名：

响应度与可解释性

指标类型：

次要指标

Outcome：

responsiveness/interpretability

Type：

Secondary indicator

测量时间点：

T0：术前；T1：术后1周；术后3个月；T2：术后 12个月；T3：术后 24个月

测量方法：

评估术前术后变化的效应量（effect size、SRM），并采用锚定法（anchor-based）结合患者满意度变化或外观评分变化估计临床意义阈值（如 MCID）

Measure time point of outcome：

T0: Before the operation; T1: One week after the operation; Three months after the operation; T2: Twelve months after the operation; T3: Twenty-four months after the operation

Measure method：

Evaluate the effect size (effect size, SRM) of preoperative and postoperative changes, and use the anchor-based method to estimate the clinical significance threshold (such as the minimal clinically important difference, MCID) by combining the changes in patient satisfaction or appearance scores.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 8 岁 years
最大 Max age 50 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:

公开/Public

盲法：

无

Blinding：

None

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

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）：

不共享原始数据

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

Do not share the original data

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：

受试者的研究相关资料（病例摘要、问卷、2D 照片、3D 点云/网格、影像学测量结果等）将以研究编号去标识化后存储与分析。研究者将建立受试者代码鉴认表（研究编号-身份信息对应表），由指定人员在院内加密环境中单独保管。除经授权的研究人员外，任何个人不得访问可识别受试者身份的信息。

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

The relevant research data of the subjects (case summaries, questionnaires, 2D photos, 3D point clouds/girds, imaging measurement results, etc.) will be anonymized by using study numbers and stored and analyzed. The researchers will establish a subject code identification table (a table correlating study numbers with identity information), which will be kept separately by designated personnel in an encrypted environment within the hospital. No individual, except authorized researchers, is allowed to access information that can identify the identity of the subjects.

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：

  2026-05-26 11:30:00