Osteoarthritis (OA) of the Knee
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Knee Function Scores(IKDC) | 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) |
| Change in Imaging-Based Knee Degeneration(T1/T2 mapping) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Knee Function Scores(WOMAC) | Baseline, 6 months, 12 months, and 24 months after treatment or surgery | Participants aged 50 years or older will be assessed using WOMAC scores |
| Change in Cartilage Morphology on 3D DESS MRI | 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. |
| Change in Proton Density Fat Fraction on Knee MRI | 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. |
| Change in Knee Function Scores(KOOS) | Baseline, 6 months, 12 months, and 24 months after treatment or surgery | Participants younger than 50 years will be assessed using KOOS scores |
| Change in Kellgren-Lawrence Grade on Knee X-ray | 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. |
Countries
China