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Cohort of Lower-Extremity Sports Injuries and Degeneration(Yongjiang Cohort)

13 augusti 2026 uppdaterad 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

500

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Kina
    • Zhejiang
      • Ningbo, Zhejiang, Kina, 315000
        • Rekrytering
        • Ningbo NO.2 Hospital,Wenzhou Medical University
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / 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.
Övrig: Routine Clinical Care
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.
Övrig: Routine Clinical Care
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Knee Function Scores(IKDC)
Tidsram: 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)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Knee Function Scores(KOOS)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Ningbo No.2 Hospital

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juni 2026

Primärt slutförande (Beräknad)

31 maj 2028

Avslutad studie (Beräknad)

31 maj 2028

Studieregistreringsdatum

Först inskickad

2 maj 2026

Först inskickad som uppfyllde QC-kriterierna

11 maj 2026

Första postat (Faktisk)

18 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

17 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

13 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • PJ-NBEY-KY-2026-121-01

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

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