Cohort of Lower-Extremity Sports Injuries and Degeneration(Yongjiang Cohort)
2026년 8월 13일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
관찰
등록 (추정된)
500
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Yi Yuan, MD
- 전화번호: +86 18858234093
- 이메일: yct1124@alumni.sjtu.edu.cn
연구 장소
-
-
Zhejiang
-
Ningbo, Zhejiang, 중국, 315000
- 모병
- Ningbo NO.2 Hospital,Wenzhou Medical University
-
연락하다:
- Chenting Ying, MD
- 전화번호: +86 18858234093
- 이메일: yct1124@alumni.sjtu.edu.cn
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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.
|
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.
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Knee Function Scores(IKDC)
기간: 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)
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Knee Function Scores(KOOS)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
- 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.
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 6월 1일
기본 완료 (추정된)
2028년 5월 31일
연구 완료 (추정된)
2028년 5월 31일
연구 등록 날짜
최초 제출
2026년 5월 2일
QC 기준을 충족하는 최초 제출
2026년 5월 11일
처음 게시됨 (실제)
2026년 5월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 13일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .