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Not yet recruiting NCT07592871

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

Observational Osteoarthritis (OA) of the Knee

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Routine Clinical Care.
Who it may be relevant to
Registry conditions: Osteoarthritis (OA) of the Knee. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • 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.

Primary outcome measures

  • Change in Knee Function Scores(IKDC) [Time frame: 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]
Secondary outcome measures (5)
  • Change in Knee Function Scores(KOOS) [Time frame: 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]
  • Change in Cartilage Morphology on 3D DESS MRI [Time frame: 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 Kellgren-Lawrence Grade on Knee X-ray [Time frame: Baseline, 6 months, 12 months, and 24 months after treatment or surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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. PMID 37936374
  • 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. PMID 38794906
  • 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. PMID 39743985

Identifiers

NCT: NCT07592871 · PJ-NBEY-KY-2026-121-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗