NCT07592871

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
24mo left

Started Jun 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

May 2, 2026

Last Update Submit

May 19, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (5)

  • Change in Knee Function Scores(KOOS)

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

  • Change in Knee Function Scores(WOMAC)

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

  • Change in Cartilage Morphology on 3D DESS MRI

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

  • Change in Proton Density Fat Fraction on Knee MRI

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

  • Change in Kellgren-Lawrence Grade on Knee X-ray

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

Study Arms (2)

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

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

Interventions

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 CohortSports Injury Cohort

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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: 37936374BACKGROUND
  • 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: 38794906BACKGROUND
  • 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: 39743985BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2026

First Posted

May 18, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

May 31, 2028

Last Updated

May 22, 2026

Record last verified: 2026-05