Cohort of Lower-Extremity Sports Injuries and Degeneration(Yongjiang Cohort)
13 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Estimé)
500
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Yi Yuan, MD
- Numéro de téléphone: +86 18858234093
- E-mail: yct1124@alumni.sjtu.edu.cn
Lieux d'étude
-
-
Zhejiang
-
Ningbo, Zhejiang, Chine, 315000
- Recrutement
- Ningbo NO.2 Hospital,Wenzhou Medical University
-
Contact:
- Chenting Ying, MD
- Numéro de téléphone: +86 18858234093
- E-mail: yct1124@alumni.sjtu.edu.cn
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Knee Function Scores(IKDC)
Délai: 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)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Knee Function Scores(KOOS)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 juin 2026
Achèvement primaire (Estimé)
31 mai 2028
Achèvement de l'étude (Estimé)
31 mai 2028
Dates d'inscription aux études
Première soumission
2 mai 2026
Première soumission répondant aux critères de contrôle qualité
11 mai 2026
Première publication (Réel)
18 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PJ-NBEY-KY-2026-121-01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .