Cohort of Lower-Extremity Sports Injuries and Degeneration(Yongjiang Cohort)
2026年8月13日 更新者：Ningbo No.2 Hospital
Bidirectional Cohort of Lower-Extremity Sports Injuries and Degeneration (Yongjiang Cohort)
This is an observational cohort study conducted at Ningbo No. 2 Hospital. The study will include patients with knee-related sports injuries or degenerative knee conditions who receive routine clinical care. The purpose is to build a standardized real-world clinical cohort and evaluate knee injury, degeneration, recovery, and long-term outcomes.
After informed consent, participants will undergo baseline data collection, including medical history, laboratory tests, questionnaires, X-ray and MRI imaging, and functional assessments. Patients younger than 50 years will mainly be assessed for sports injury and functional recovery, while patients aged 50 years or older will receive additional sarcopenia-related assessments such as grip strength, DXA testing, and gait evaluation.
No experimental treatment, randomization, or intervention will be assigned. Participants will be followed at about 6, 12, and 24 months after treatment or surgery to assess knee function, imaging changes, reinjury, reoperation, pain, quality of life, falls, and functional decline. The study plans to enroll about 500 participants.
研究概览
详细说明
This is a bidirectional observational cohort study.
Baseline and historical clinical information will be collected when available, and participants will also be followed prospectively at approximately 6, 12, and 24 months after treatment or surgery.
研究类型
观察性的
注册 (估计的)
500
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Yi Yuan, MD
- 电话号码：+86 18858234093
- 邮箱：yct1124@alumni.sjtu.edu.cn
学习地点
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Zhejiang
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Ningbo、Zhejiang、中国、315000
- 招聘中
- Ningbo NO.2 Hospital,Wenzhou Medical University
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接触：
- Chenting Ying, MD
- 电话号码：+86 18858234093
- 邮箱：yct1124@alumni.sjtu.edu.cn
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
The study population will include patients with knee-related diseases or injuries who receive routine clinical care through the orthopedic and sports medicine outpatient, emergency, and inpatient services at Ningbo No. 2 Hospital.
Eligible participants will include patients with sports injuries, degenerative knee conditions, or related knee disorders.
Participants will be managed according to routine clinical practice and followed as part of an observational cohort.
描述
Inclusion Criteria:
- Patients who plan to receive relevant clinical evaluation or treatment at Ningbo No. 2 Hospital and are able to complete baseline assessment.
- Patients with a clinical diagnosis of knee-related injury or degenerative knee disease.
- Patients who are willing to provide informed consent and participate in follow-up.
Exclusion Criteria:
- Patients who are unable to complete the core baseline assessments or have substantial missing key clinical information.
- Patients with severe comorbid conditions or cognitive impairment that may affect assessment of the main outcomes or prevent participation in follow-up.
- Patients who are considered by the investigator to be unsuitable for inclusion in this cohort.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Sports Injury Cohort
Participants with knee-related sports injuries as the main clinical condition.
This cohort will be observed for injury characteristics, treatment patterns, tissue repair, functional recovery, and subsequent degenerative changes during follow-up.
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Participants will receive routine clinical care as determined by their treating physicians according to usual clinical practice.
The study will not assign any treatment, randomization, or experimental intervention.
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Degenerative Knee Disease Cohort
Participants with degenerative knee conditions, including knee osteoarthritis or related degenerative disorders, as the main clinical condition.
This cohort will be observed for degeneration severity, symptom burden, imaging progression, body composition, gait changes, and clinical outcomes during follow-up.
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Participants will receive routine clinical care as determined by their treating physicians according to usual clinical practice.
The study will not assign any treatment, randomization, or experimental intervention.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Knee Function Scores(IKDC)
大体时间：Baseline, 6 months, 12 months, and 24 months after treatment or surgery
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Change in knee function from baseline will be assessed using validated patient-reported outcome scores(IKDC)
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Baseline, 6 months, 12 months, and 24 months after treatment or surgery
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Change in Imaging-Based Knee Degeneration(T1/T2 mapping)
大体时间：Baseline, 6 months, 12 months, and 24 months after treatment or surgery
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Progression of knee degeneration will be assessed using quantitative MRI sequences ( T1/T2 mapping).
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Baseline, 6 months, 12 months, and 24 months after treatment or surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Knee Function Scores(KOOS)
大体时间：Baseline, 6 months, 12 months, and 24 months after treatment or surgery
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Participants younger than 50 years will be assessed using KOOS scores
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Baseline, 6 months, 12 months, and 24 months after treatment or surgery
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Change in Knee Function Scores(WOMAC)
大体时间：Baseline, 6 months, 12 months, and 24 months after treatment or surgery
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Participants aged 50 years or older will be assessed using WOMAC scores
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Baseline, 6 months, 12 months, and 24 months after treatment or surgery
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Change in Cartilage Morphology on 3D DESS MRI
大体时间：Baseline, 6 months, 12 months, and 24 months after treatment or surgery
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Change in cartilage morphology will be assessed using three-dimensional double-echo steady-state magnetic resonance imaging.
Cartilage structural changes will be evaluated according to the study imaging protocol, with greater structural deterioration indicating more severe knee degeneration.
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Baseline, 6 months, 12 months, and 24 months after treatment or surgery
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Change in Proton Density Fat Fraction on Knee MRI
大体时间：Baseline, 6 months, 12 months, and 24 months after treatment or surgery
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Change in proton density fat fraction will be assessed using magnetic resonance imaging.
Proton density fat fraction values will be used to evaluate fat-related tissue changes around the knee according to the study imaging protocol.
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Baseline, 6 months, 12 months, and 24 months after treatment or surgery
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Change in Kellgren-Lawrence Grade on Knee X-ray
大体时间：Baseline, 6 months, 12 months, and 24 months after treatment or surgery
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Change in radiographic knee degeneration will be assessed using the Kellgren-Lawrence grading system on knee X-ray.
The Kellgren-Lawrence grade ranges from 0 to 4, with higher grades indicating more severe radiographic osteoarthritis.
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Baseline, 6 months, 12 months, and 24 months after treatment or surgery
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Williams AA, Koltsov JCB, Brett A, He J, Chu CR. Using 3D MRI Bone Shape to Predict Pre-Osteoarthritis of the Knee 2 Years After Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2023 Dec;51(14):3677-3686. doi: 10.1177/03635465231207615. Epub 2023 Nov 7.
- Nakanishi Y, Hegarty P, Vivacqua T, Firth A, Milner JS, Pritchett S, Willits K, Litchfield R, Bryant D, Getgood AMJ. Quantitative MRI Analysis of Patellofemoral Joint Cartilage Health 2 Years After Anterior Cruciate Ligament Reconstruction and Lateral Extra-Articular Tenodesis. Am J Sports Med. 2024 Jun;52(7):1773-1783. doi: 10.1177/03635465241248642. Epub 2024 May 25.
- Watanabe S, Joseph GB, Sato D, Lansdown DA, Brandao Guimaraes J, Link TM, Ma CB. Longitudinal Changes in Medial Meniscal Extrusion After ACL Injury and Reconstruction and Its Relationship With Cartilage Degeneration Assessed Using MRI-Based T1rho and T2 Analysis. Am J Sports Med. 2025 Feb;53(2):350-359. doi: 10.1177/03635465241305734. Epub 2025 Jan 2.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月1日
初级完成 (估计的)
2028年5月31日
研究完成 (估计的)
2028年5月31日
研究注册日期
首次提交
2026年5月2日
首先提交符合 QC 标准的
2026年5月11日
首次发布 (实际的)
2026年5月18日
研究记录更新
最后更新发布 (实际的)
2026年8月17日
上次提交的符合 QC 标准的更新
2026年8月13日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
IPD 计划说明
The plan for sharing individual participant data has not yet been determined.
This study involves clinical, imaging, laboratory, questionnaire, functional assessment, and follow-up data, and any future data sharing will need to comply with applicable laws, institutional policies, ethics committee requirements, and the informed consent obtained from participants.
The study team may consider sharing de-identified data with qualified researchers after completion of the study and publication of the main results, subject to institutional approval and a signed data use agreement.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.