NCT02070224已完成不适用
Evaluation of the Prognostic Value of Biological Markers, Coll2-1 and Coll2-1NO2 in Patients With Symptomatic Knee Osteoarthritis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Artialis
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- MRI will be analysed with semiquantitative Whole-Organ Magnetic Resonance Imaging Scoring method (WORMS)
研究概览
简要总结
The purposes of this study are to assess the prognostic value of serum and urinary biomarkers Coll2-1 and Coll2-1NO2 at baseline, and their change over the first year, on the progression of knee osteoarthritis MRI scores at 12 months, on the progression of knee osteoarthritis clinical score at 12 months. Additionally, this study will search for correlations between serum and urinary biomarkers Coll2-1 and Coll2-1NO2 at baseline with the radiographic, MRI and clinical severity of knee osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 45 to 80 years with a BMI ≤ 40
- •With an uni- or bilateral femorotibial knee osteoarthritis associated or not with a femoro-patellar knee osteoarthritis
- •Responding to clinical and radiological criteria of the ACR
- •Symptomatic for more than 6 months (for the most painful knee)
- •K&L radiological grade of Felson II or III
- •With a cartilage lesion identified during MRI and either at least 1 out of 4 MRI severity criteria:
- •bone oedema
- •meniscal lesion in the central region of the medial compartment
- •effusion without answer to corticosteroids
- •zone without cartilage
- •or at least 1 out of 3 clinical severity criteria:
- •genu varum>3°
- •previous meniscal surgery
- •known polyarthritis
- •effusion on the target knee
- •Sign an informed consent after being informed
- •Able to follow the instructions of the study
- •With an agreement from the physicians having established the diagnosis of osteoarthritis (if any) to give relevant information to the investigator
- •With health insurance (for France).
排除标准
- •For osteoarthritis:
- •Isolated patellofemoral arthritis
- •Chondromatosis or villo-nodular synovioma of the knee
- •Recent trauma-induced knee pain
- •Joint disease due to joint dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, hemophilia, hemochromatosis, ...
- •inflammatory pathologies as rheumatoid polyarthritis, gout arthritis, infectious arthritis
- •Diseases that may interfere with the evaluation of osteoarthritis (radiculalgia of lower limbs, arteritis, ...)
- •Genu valgum (degree considered as pathological by the physician)
- •For previous treatments:
- •Treatment with strontium ranelate, bisphosphonates, SERM and PTH
- •For known associated diseases:
- •Serious associated diseases: severe liver or renal failure, uncontrolled cardiovascular disease, HIV, hepatitis B or C
- •Knee tumor
- •For patients:
- •Patient who participated to a therapeutic clinical trial 3 months before the T0 inclusion visit
- •Patient who are the subject of a judicial protection measure or under guardianship
- •Pregnant woman
- •For MRI contraindications:
- •Patient with a pacemaker, an implantable defibrillator, neurosurgical clips, a neurostimulator, cochlear implant, a stent, an insulin pump
- •Patient with a ferromagnetic splinter in the body, or having wire sutures
- •Serious mobility problem (Parkinson, tremors)
研究组 & 干预措施
Knee osteoarthritis
Other
干预措施: Serum and urine samples collections (Other)
Knee osteoarthritis
Other
干预措施: Imaging (x-rays and MRI) (Other)
结局指标
主要结局
MRI will be analysed with semiquantitative Whole-Organ Magnetic Resonance Imaging Scoring method (WORMS)
时间窗: 12 month
次要结局
- Knee injury and Osteoarthritis Outcome Score (KOOS) and Visual Analogue Scales (VAS) for mean knee pain and global patient assessment of disease activity(12 month)
研究者
研究点 (3)
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