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Osteoarthritis (OA) of the KneeNCT07592871

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

An observational study of Osteoarthritis (OA) of the Knee, run by Ningbo No.2 Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Osteoarthritis (OA) of the Knee
What is being tested?
Routine Clinical Care
How many people
500 participants
Where
1 siteChina
Study dates
1 Jun 2026to 31 May 2028
How long will I take part?
2 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yi Yuan, MD contact

+86 18858234093

yct1124@alumni.sjtu.edu.cn

China1 site, 1 recruiting

  • Ningbo NO.2 Hospital,Wenzhou Medical University

    Ningbo, Zhejiang, 315000

    Chenting Ying, MD, +86 18858234093, yct1124@alumni.sjtu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Routine Clinical Care
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Routine Clinical CareOther

    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.

Study groups in NCT07592871
Study groupRoleWhat they receive
Sports Injury CohortParticipants 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.
Receives: Other: Routine Clinical Care
Degenerative Knee Disease CohortParticipants 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.
Receives: Other: Routine Clinical Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Knee Function Scores(IKDC)

    Change in knee function from baseline will be assessed using validated patient-reported outcome scores(IKDC)

    Measured: Baseline, 6 months, 12 months, and 24 months after treatment or surgery

  2. Change in Imaging-Based Knee Degeneration(T1/T2 mapping)

    Progression of knee degeneration will be assessed using quantitative MRI sequences ( T1/T2 mapping).

    Measured: Baseline, 6 months, 12 months, and 24 months after treatment or surgery

Secondary outcomes (5)

  1. Change in Knee Function Scores(KOOS)

    Participants younger than 50 years will be assessed using KOOS scores

    Measured: Baseline, 6 months, 12 months, and 24 months after treatment or surgery

  2. Change in Knee Function Scores(WOMAC)

    Participants aged 50 years or older will be assessed using WOMAC scores

    Measured: Baseline, 6 months, 12 months, and 24 months after treatment or surgery

  3. 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.

    Measured: Baseline, 6 months, 12 months, and 24 months after treatment or surgery

  4. 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.

    Measured: Baseline, 6 months, 12 months, and 24 months after treatment or surgery

  5. 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.

    Measured: Baseline, 6 months, 12 months, and 24 months after treatment or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2026
  2. Study start1 Jun 2026
  3. Primary completion31 May 2028 (estimated)
  4. Study completion31 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
500 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07592871
Sponsor's protocol ID
PJ-NBEY-KY-2026-121-01
Status last verified
Aug 2026
First submitted
2 May 2026
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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.

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.

    PubMed 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.

    PubMed 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.

    PubMed 39743985

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoarthritis (OA) of the Knee, run by Ningbo No.2 Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yi Yuan, MD (+86 18858234093, yct1124@alumni.sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Knee Function Scores(IKDC) (time frame: Baseline, 6 months, 12 months, and 24 months after treatment or surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07592871, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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