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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Change in Knee Function Scores(IKDC) [Срок оценки: Baseline, 6 months, 12 months, and 24 months after treatment or surgery]
• Change in Imaging-Based Knee Degeneration(T1/T2 mapping) [Срок оценки: Baseline, 6 months, 12 months, and 24 months after treatment or surgery]

Вторичные конечные точки (5)

• Change in Knee Function Scores(KOOS) [Срок оценки: Baseline, 6 months, 12 months, and 24 months after treatment or surgery]
• Change in Knee Function Scores(WOMAC) [Срок оценки: Baseline, 6 months, 12 months, and 24 months after treatment or surgery]
• Change in Cartilage Morphology on 3D DESS MRI [Срок оценки: Baseline, 6 months, 12 months, and 24 months after treatment or surgery]
• Change in Proton Density Fat Fraction on Knee MRI [Срок оценки: Baseline, 6 months, 12 months, and 24 months after treatment or surgery]
• Change in Kellgren-Lawrence Grade on Knee X-ray [Срок оценки: Baseline, 6 months, 12 months, and 24 months after treatment or surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 37936374
• 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. PMID 38794906
• 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. PMID 39743985

Идентификаторы

NCT: NCT07592871 · PJ-NBEY-KY-2026-121-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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