Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Knee Function Scores(IKDC) | 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) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Knee Function Scores(KOOS) | 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Yuan, MD | Contact | +86 18858234093 | yct1124@alumni.sjtu.edu.cn |
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37936374 | Background | 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. | |
| 38794906 | Background | 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. |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 13, 2026 | May 11, 2026 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
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 | 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 | 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 | 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 |
| 39743985 | Background | 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. |