NCT02667756Unknown不适用
Identification of Prognostic Biomarkers for Osteoarthritis Risk Following Knee Injury: the Knee Injury Cohort @ the Kennedy Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS)-4 score at 2 years
研究概览
简要总结
This observational study seeks to identify and validate novel soluble biomarkers (within blood, synovial fluid, urine) which contribute to the prognostic assessment of an individual with an acute knee injury, a group of individuals in which ~50% will progress to symptomatic radiographic knee osteoarthritis (OA).
150 individuals will be followed over 5 years with clinical assessment including validated questionnaires, biological sampling and radiological imaging (X ray, magnetic resonance imaging (MRI)).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically significant acute knee injury within 8 weeks of recruitment
- •Aged 16-50
- •Knee effusion, evident clinically or by MRI
- •Evidence on MRI of structural injury (from list of relevant injuries)
- •Informed written consent
排除标准
- •Knee injured more than 8 weeks prior to recruitment
- •Pre-existing advanced radiographic OA (Kellgren Lawrence (KL) grade 3-4) of same side knee at baseline
- •Known history of inflammatory/septic arthritis of same side knee
- •Knee replacement - previous or planned within 2 years of study start
- •Active other (treated) inflammatory disease or infection
- •Positive pregnancy test
- •Not consenting, or contraindication to provide blood samples:
- •Bilateral mastectomy
- •Bilateral fistulae for renal dialysis
- •Unable to give informed written consent in English
结局指标
主要结局
Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS)-4 score at 2 years
时间窗: 2 years
Summary score for KOOS questionnaire
次要结局
- Change from baseline in Whole Organ MRI Score (WORMS) at 2 years(2 years)
- Change from baseline in Kellgren Lawrence grade at 5 years(5 years)
- Change from baseline in Kellgren Lawrence grade at 2 years(2 years)
- Change from baseline in KOOS-4 score at 3 months(3 months)
- Change from baseline in KOOS-4 score at 5 years(5 years)
- Change from baseline in MRI WORMS score at 5 years(5 years)
- Change from baseline in physical activity level (International Physical Activity Questionnaire, IPAQ) at 2 years(2 years)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
New Biomarkers and Therapeutic Targets in Osteoporosis Via Omics TechnologiesOsteoporosis, PostmenopausalOsteoporosis FractureOsteoporosis, SevereNCT06525688National and Kapodistrian University of Athens60
已完成
不适用
The Prognostic Value of Serum Biomarkers in OsteosarcomaOsteosarcomaNCT05093101Istituto Ortopedico Rizzoli600
招募中
不适用
Biomarkers Related to Bone in Pediatric Gaucher DiseaseBone DiseasesGaucher DiseaseNCT06116071Lysosomal and Rare Disorders Research and Treatment Center, Inc.20
已完成
4 期
Evaluation of Bone Markers as Diagnostic Tools for Early Detection of Bone Metastases in Patients With High Risk Prostate CancerProstate CancerNCT00391690Novartis99
进行中（未招募）
不适用
Novel Serum Biomarkers for Identifying Plaque Erosion in ACS and Predicting PrognosisPlaque RuptureAcute Coronary SyndromesNCT06763835Xuebo Liu301