Cohort of Lower-Extremity Sports Injuries and Degeneration(Yongjiang Cohort)
ConditionOsteoarthritis (OA) of the Knee
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorNingbo No.2 Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Routine Clinical Care
Other interventionParticipants 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.
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Sports Injury Cohort1 intervention
Group B: Degenerative Knee Disease Cohort1 intervention
Trial outcomes
Primary outcomes
1
Change in Knee Function Scores(IKDC)
Change in knee function from baseline will be assessed using validated patient-reported outcome scores(IKDC)
Time frame
Baseline, 6 months, 12 months, and 24 months after treatment or surgery2
Change in Imaging-Based Knee Degeneration(T1/T2 mapping)
Progression of knee degeneration will be assessed using quantitative MRI sequences ( T1/T2 mapping).
Time frame
Baseline, 6 months, 12 months, and 24 months after treatment or surgerySecondary outcomes
1
Change in Knee Function Scores(KOOS)
Participants younger than 50 years will be assessed using KOOS scores
Time frame
Baseline, 6 months, 12 months, and 24 months after treatment or surgery2
Change in Knee Function Scores(WOMAC)
Participants aged 50 years or older will be assessed using WOMAC scores
Time frame
Baseline, 6 months, 12 months, and 24 months after treatment or surgery3
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.
Time frame
Baseline, 6 months, 12 months, and 24 months after treatment or surgery4
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.
Time frame
Baseline, 6 months, 12 months, and 24 months after treatment or surgerySponsors and contacts
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Source ClinicalTrials.gov