ChiCTR2500114704 版本V1.0 版本创建时间2025/12/16 17:18:09 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：

ChiCTR2500114704 

最近更新日期：

Date of Last Refreshed on：

2025-12-16 17:17:59 

注册时间：

Date of Registration：

2025-12-16 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

医护康一体化延续护理在膝关节前交叉韧带合并半月板损伤术后患者功能康复中的应用

Public title：

Application of integrated medical and nursing continuity care in functional rehabilitation of patients after anterior cruciate ligament and meniscus injury surgery

注册题目简写：

English Acronym：

研究课题的正式科学名称：

医护康一体化延续护理在膝关节前交叉韧带合并半月板损伤术后患者功能康复中的应用

Scientific title：

Application of integrated medical and nursing continuity care in functional rehabilitation of patients after anterior cruciate ligament and meniscus injury surgery

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：

陈欢欢 

研究负责人：

陈欢欢 

Applicant：

Chen Huanhuan 

Study leader：

Chen Huanhuan 

申请注册联系人电话：

Applicant telephone：

+86 137 8014 9899

研究负责人电话：

Study leader's telephone：

+86 137 8014 9899

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：

543727747@qq.com

研究负责人电子邮件：

Study leader's E-mail：

543727747@qq.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：

中国浙江省温州市永嘉县东瓯街道林垟大厦A栋2301室

研究负责人通讯地址：

中国浙江省温州市永嘉县东瓯街道林垟大厦A栋2301室

Applicant address：

Room 2301, Building A, Linyang Building, Dong'ou Street, Yongjia County, Wenzhou City, Zhejiang Province, China

Study leader's address：

Room 2301, Building A, Linyang Building, Dong'ou Street, Yongjia County, Wenzhou City, Zhejiang Province, China

申请注册联系人邮政编码：

Applicant postcode：

325000

研究负责人邮政编码：

Study leader's postcode：

325000

申请人所在单位：

温州医科大学附属第二医院育英儿童医院

Applicant's institution：

The Second A?liated Hospital and Yuying Children’s Hospital of Wenzhou Medical University

研究负责人所在单位：

温州医科大学附属第二医院育英儿童医院

Affiliation of the Leader：

The Second A?liated Hospital and Yuying Children’s Hospital of Wenzhou Medical University

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：

伦审(2025-K-338-02)

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：

温州医科大学附属第二医院 温州医科大学附属育英儿童医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the Second Affiliated Hospital of Wenzhou Medical University and Wenzhou Medical University Affiliated Yuying Children's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2025-11-10 00:00:00

伦理委员会联系人：

陈苑

Contact Name of the ethic committee：

Chen Yuan

伦理委员会联系地址：

中国浙江省温州市龙湾区温州大道东段1111号

Contact Address of the ethic committee：

No. 1111, East Section of Wenzhou Avenue, Longwan District, Wenzhou City, Zhejiang Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 137 5849 6849

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：

温州医科大学附属第二医院育英儿童医院

Primary sponsor：

The Second A?liated Hospital and Yuying Children’s Hospital of Wenzhou Medical University

研究实施负责（组长）单位地址：

中国浙江省温州市学院西路109号

Primary sponsor's address：

109, Xueyuanxi road, Wenzhou,Zhejiang,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)：

浙江省

市(区县)：

Country：

China

Province：

Zhejiang

City：

单位(医院)：

温州医科大学附属第二医院育英儿童医院

具体地址：

中国浙江省温州市学院西路109号

Institution
hospital：

The Second Affiliated Hospital and Yuying Children’s Hospital of Wenzhou Medical University

Address：

109, Xueyuanxi road, Wenzhou,Zhejiang,China

经费或物资来源：

自筹经费

Source(s) of funding：

Self-funded

Target disease：

anterior cruciate ligament and meniscus injury

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：

本研究针对接受膝关节前交叉韧带重建联合半月板修复术后患者，对不同延续护理模式的随访结果展开分析，进而构建出医护康一体化延续护理模式。该模式着重发挥护士的“桥梁”作用，充分拓展其职能的广度与深度，为术后患者在功能锻炼、切口照护、疼痛管理、饮食调控及高危并发症预防等方面，提供专业、全程且无缝衔接的延续护理服务。此举旨在填补患者出院后护理需求的“最后一公里”空白，切实满足患者需求，提高患者功能锻炼依从性，推动康复进程，提升患者满意度。  

Objectives of Study：

This study focused on patients who underwent anterior cruciate ligament reconstruction combined with meniscus repair, analyzing the follow-up outcomes of different continuous care models, and subsequently establishing an integrated medical-nursing continuous care model. This model emphasizes the nurse's role as a 'bridge,' fully expanding the scope and depth of their functions to provide professional, comprehensive, and seamless continuous care services for postoperative patients in areas such as functional exercise, incision care, pain management, dietary regulation, and prevention of high-risk complications. The aim is to address the 'last mile' gap in care after patient discharge, effectively meet patient needs, improve compliance with functional exercises, promote the rehabilitation process, and enhance patient satisfaction.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.初次行单侧膝关节前交叉韧带重建合并半月板修复术，且均由本院运动医学科医师进行手术治疗者。 2.文化程度小学及以上且有网络和智能手机等设备，会使用微信者。 3.认知及表达能力正常者。 4.患者或家属知情同意并自愿参与本研究。

Inclusion criteria

1. Patients undergoing their first unilateral anterior cruciate ligament reconstruction combined with meniscus repair, with all surgeries performed by sports medicine physicians at our hospital. 2. Individuals with at least a primary school education who have access to the internet and a smartphone, and are able to use WeChat. 3. Individuals with normal cognitive and expressive abilities. 4. Patients or their family members who have provided informed consent and voluntarily agree to participate in this study.

排除标准：

1.合并后交叉韧带损伤或合并血管及神经损伤者。 2.合并严重心、肺、肝、肾等系统疾病者。 3.随访脱落者。

Exclusion criteria：

1. Those with combined cruciate ligament injuries or combined vascular and nerve injuries. 2. Those with severe diseases of the heart, lungs, liver, kidneys, or other systems. 3. Those lost to follow-up.

研究实施时间：

Study execute time：

从 From 2025-12-19 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-12-19 00:00:00 至 To 2026-12-31 00:00:00  

干预措施：

Interventions：

组别：

干预组

样本量：

47

Group：

Intervention group

Sample size：

干预措施：

采用基于德尔菲法构建的医护康一体化ACL合并半月板损伤术后延续护理方案 1.综合档案建立与动态评估 建立个人康复档案，指导患者使用康复日记记录每日功能变化。研究者定期随访，与患者共同解读Lysholm评分等报告，使其直观了解进展。 2.个性化渐进性功能锻炼 医护康团队依据动态评估结果，共同为患者制定包含明确时间、频率与进阶标准的个性化周锻炼计划。 3.康复信念构建与价值内化 采用动机性访谈技术，引导患者将康复目标与具体生活价值（如“独立上下班、无恐惧上下楼梯等”）相联结，共同设定可衡量的、与膝关节功能恢复直接相关的个性化阶段目标。 4.支持性关系与团队督导 构建医护康三方线上支持群提供即时答疑，并定期组织“康复榜样”进行线上经验分享。 5.治疗性投入与自我监控 在个性化锻炼计划中引入游戏化元素（如打卡、徽章），奖励患者完成每日必需的康复任务（如冰敷、角度训练、肌力训练等），并教授患者运用正念呼吸、疼痛接纳等技巧进行情绪调节，重点管理与“膝关节不稳感”和“再次受伤恐惧”相关的焦虑情绪，引导其关注积极体验。 6.进展性反馈与成就强化 在随访中系统梳理患者的打卡记录、功能进步数据与克服的困难，通过举行微型“康复庆功会”，对患者达到的每一个里程碑（如完全伸膝、无辅助行走、单腿站立稳定等）予以成就认可。

干预措施代码：

Intervention：

Adopted a post-operative continuous care program for ACL combined with meniscus injury recovery, integrating medical, nursing, and rehabilitation care based on the Delphi method: 1. Comprehensive Record Establishment and Dynamic Assessment Establish personal rehabilitation records and guide patients to use a rehabilitation diary to track daily functional changes. Researchers conduct regular follow-ups and interpret reports such as the Lysholm score with patients, allowing them to visually understand their progress. 2. Personalized Progressive Functional Exercise The medical-nursing-rehabilitation team formulates a personalized weekly exercise plan with clear timing, frequency, and progression standards based on dynamic assessment results. 3. Building Rehabilitation Belief and Internalizing Value Using motivational interviewing techniques, guide patients to link rehabilitation goals with specific life values (e.g., "independently commuting, fearlessly climbing stairs"), and co-set measurable, personalized stage goals directly related to knee function recovery. 4. Supportive Relationships and Team Supervision Create an online support group involving medical, nursing, and rehabilitation staff to provide immediate answers, and regularly organize online experience-sharing sessions with "rehabilitation role models." 5. Therapeutic Engagement and Self-Monitoring Introduce gamification elements (such as check-ins and badges) in the personalized exercise plan to reward patients for completing daily essential rehabilitation tasks (e.g., ice therapy, range-of-motion training, muscle-strengthening exercises). Teach patients techniques such as mindful breathing and pain acceptance to regulate emotions, focusing on anxiety related to "knee instability" and "fear of re-injury," guiding them to focus on positive experiences. 6. Progressive Feedback and Achievement Reinforcement During follow-ups, systematically summarize patients' check-in records, functional progress data, and difficulties overcome. Conduct mini "rehabilitation celebration meetings" to recognize every milestone achieved by patients (e.g., full knee extension, walking without assistance, stable single-leg stance).

Intervention code：

组别：

对照组

样本量：

47

Group：

Control group

Sample size：

干预措施：

向患者发放出院患者健康教育及康复指导，为出院患者提供纸质指导；医护人员设置微信群，便于患者或家属在线咨询；出院1个月内完成电话随访；患者按时于出院时、干预后2周、1个月、3个月及6个月至医院，完成门诊复查。

干预措施代码：

Intervention：

Provide discharged patients with health education and rehabilitation guidance, offering printed instructions; medical staff set up WeChat groups to facilitate online consultations for patients or their families; conduct telephone follow-ups within one month after discharge; patients return to the hospital on time for outpatient check-ups at discharge, 2 weeks, 1 month, 3 months, and 6 months after intervention.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 温州市 

市(区县)：

 温州市 

Country：

China 

Province：

Wenzhou 

City：

 

单位(医院)：

温州医科大学附属第二医院育英儿童医院 

单位级别：

三甲 

Institution
hospital：

The Second Affiliated Hospital and Yuying Children’s Hospital of Wenzhou Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

膝关节功能

指标类型：

主要指标

Outcome：

Knee joint function

Type：

Primary indicator

测量时间点：

出院时、干预后2周、1个月、3个月及6个月

测量方法：

Lysholm 膝关节评分

Measure time point of outcome：

At discharge, 2 weeks, 1 month, 3 months, and 6 months after intervention

Measure method：

Lysholm Knee Scoring Scale

指标中文名：

运动功能

指标类型：

次要指标

Outcome：

Motor function

Type：

Secondary indicator

测量时间点：

出院时、干预后2周、1个月、3个月及6个月

测量方法：

Tegner 运动功能评分

Measure time point of outcome：

At discharge, 2 weeks, 1 month, 3 months, and 6 months after intervention

Measure method：

Tegner Activity Level Scale

指标中文名：

膝关节自我效能

指标类型：

次要指标

Outcome：

Knee Joint Self-Efficacy

Type：

Secondary indicator

测量时间点：

出院时、干预后2周、1个月、3个月及6个月

测量方法：

膝关节自我效能量表

Measure time point of outcome：

At discharge, 2 weeks, 1 month, 3 months, and 6 months after intervention

Measure method：

the Knee Self-Efficacy Scale,K-SES

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 65 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）：

采用便利抽样的方法，按照出院顺序给与1—100数字编号，奇数者纳入干预组，偶数者纳入对照组。

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

Using a convenience sampling method, numbers from 1 to 100 were assigned according to the discharge order, with odd numbers included in the intervention group and even numbers in the control group.

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：

对数据收集者、录入者及评估者实施盲法

Blinding：

Implement blinding for data collectors, data entry personnel, and evaluators

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

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）：

2025.12.16中国临床试验注册中心

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

December 16, 2025, Chinese Clinical Trial Registry

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：

病例报告书及SPSS22.0软件

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

Case Report Form and SPSS 22.0 Software

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：

  2025-12-16 17:17:59