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NCT Number: NCT07592871

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.

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Key information

Conditions

Osteoarthritis (OA) of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Routine Clinical Care

Other

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.

Primary outcomes

  1. Change in Knee Function Scores(IKDC)

    Time frame: 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)

  2. Change in Imaging-Based Knee Degeneration(T1/T2 mapping)

    Time frame: 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).

Secondary outcomes

  1. Change in Knee Function Scores(KOOS)

    Time frame: Baseline, 6 months, 12 months, and 24 months after treatment or surgery

    Participants younger than 50 years will be assessed using KOOS scores

  2. Change in Knee Function Scores(WOMAC)

    Time frame: Baseline, 6 months, 12 months, and 24 months after treatment or surgery

    Participants aged 50 years or older will be assessed using WOMAC scores

  3. Change in Cartilage Morphology on 3D DESS MRI

    Time frame: 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.

  4. Change in Proton Density Fat Fraction on Knee MRI

    Time frame: 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.

  5. Change in Kellgren-Lawrence Grade on Knee X-ray

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yi Yuan, MD

CONTACT

[email protected]

+86 18858234093

Sponsors and collaborators

Lead sponsor

Ningbo No.2 Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 18, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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