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

May 19, 2026 updated by: Ningbo No.2 Hospital

Bidirectional 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: 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.
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline, 6 months, 12 months, and 24 months after treatment or surgery
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).
Baseline, 6 months, 12 months, and 24 months after treatment or surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 6 months, 12 months, and 24 months after treatment or surgery
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
Baseline, 6 months, 12 months, and 24 months after treatment or surgery
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.
Baseline, 6 months, 12 months, and 24 months after treatment or surgery
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.
Baseline, 6 months, 12 months, and 24 months after treatment or surgery
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.
Baseline, 6 months, 12 months, and 24 months after treatment or surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ningbo No.2 Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

May 31, 2028

Study Registration Dates

First Submitted

May 2, 2026

First Submitted That Met QC Criteria

May 11, 2026

First Posted (Actual)

May 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PJ-NBEY-KY-2026-121-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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