Cohort of Lower-Extremity Sports Injuries and Degeneration(Yongjiang Cohort)
13. august 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Antatt)
500
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Yi Yuan, MD
- Telefonnummer: +86 18858234093
- E-post: yct1124@alumni.sjtu.edu.cn
Studiesteder
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Zhejiang
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Ningbo, Zhejiang, Kina, 315000
- Rekruttering
- Ningbo NO.2 Hospital,Wenzhou Medical University
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Ta kontakt med:
- Chenting Ying, MD
- Telefonnummer: +86 18858234093
- E-post: yct1124@alumni.sjtu.edu.cn
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Knee Function Scores(IKDC)
Tidsramme: 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)
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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)
Tidsramme: 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).
|
Baseline, 6 months, 12 months, and 24 months after treatment or surgery
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Knee Function Scores(KOOS)
Tidsramme: Baseline, 6 months, 12 months, and 24 months after treatment or surgery
|
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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juni 2026
Primær fullføring (Antatt)
31. mai 2028
Studiet fullført (Antatt)
31. mai 2028
Datoer for studieregistrering
Først innsendt
2. mai 2026
Først innsendt som oppfylte QC-kriteriene
11. mai 2026
Først lagt ut (Faktiske)
18. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PJ-NBEY-KY-2026-121-01
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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