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.
調査の概要
詳細な説明
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.
研究の種類
観察的
入学 (推定)
500
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Yi Yuan, MD
- 電話番号：+86 18858234093
- メール：yct1124@alumni.sjtu.edu.cn
研究場所
-
-
Zhejiang
-
Ningbo、Zhejiang、中国、315000
- 募集
- Ningbo NO.2 Hospital,Wenzhou Medical University
-
コンタクト：
- Chenting Ying, MD
- 電話番号：+86 18858234093
- メール：yct1124@alumni.sjtu.edu.cn
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
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.
|
|
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.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Knee Function Scores(IKDC)
時間枠：Baseline, 6 months, 12 months, and 24 months after treatment or surgery
|
Change in knee function from baseline will be assessed using validated patient-reported outcome scores(IKDC)
|
Baseline, 6 months, 12 months, and 24 months after treatment or surgery
|
|
Change in Imaging-Based Knee Degeneration(T1/T2 mapping)
時間枠：Baseline, 6 months, 12 months, and 24 months after treatment or surgery
|
Progression of knee degeneration will be assessed using quantitative MRI sequences ( T1/T2 mapping).
|
Baseline, 6 months, 12 months, and 24 months after treatment or surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Knee Function Scores(KOOS)
時間枠：Baseline, 6 months, 12 months, and 24 months after treatment or surgery
|
Participants younger than 50 years will be assessed using KOOS scores
|
Baseline, 6 months, 12 months, and 24 months after treatment or surgery
|
|
Change in Knee Function Scores(WOMAC)
時間枠：Baseline, 6 months, 12 months, and 24 months after treatment or surgery
|
Participants aged 50 years or older will be assessed using WOMAC scores
|
Baseline, 6 months, 12 months, and 24 months after treatment or surgery
|
|
Change in Cartilage Morphology on 3D DESS MRI
時間枠：Baseline, 6 months, 12 months, and 24 months after treatment or surgery
|
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.
|
Baseline, 6 months, 12 months, and 24 months after treatment or surgery
|
|
Change in Proton Density Fat Fraction on Knee MRI
時間枠：Baseline, 6 months, 12 months, and 24 months after treatment or surgery
|
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.
|
Baseline, 6 months, 12 months, and 24 months after treatment or surgery
|
|
Change in Kellgren-Lawrence Grade on Knee X-ray
時間枠：Baseline, 6 months, 12 months, and 24 months after treatment or surgery
|
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.
|
Baseline, 6 months, 12 months, and 24 months after treatment or surgery
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年6月1日
一次修了 (推定)
2028年5月31日
研究の完了 (推定)
2028年5月31日
試験登録日
最初に提出
2026年5月2日
QC基準を満たした最初の提出物
2026年5月11日
最初の投稿 (実際)
2026年5月18日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月17日
QC基準を満たした最後の更新が送信されました
2026年8月13日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。