Efficacy Evaluation of Intraarticular Collagen-polyvinyl Pyrrolidone (Fibroquel®) vs Hylan G-F 20 (Synvisc®) in the Treatment of Knee Osteoarthritis. A Double-blind, Controlled, Randomised, Parallel-group Non-inferiority Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- International Knee Documentation Committee (IKDC).
研究概览
简要总结
Articular cartilage degradation is the main characteristic of osteoarthritis (OA), involving enzymatic and inflammatory mechanisms that change it into a chronic disease. Since articular cartilage shows limited regenerative ability, several intra-articular drugs have been developed in order to decrease inflammation and provide a better clinical outcome to the patient.
详细描述
This study aims to compare effectiveness of the treatment with intra-articular administration of collagen-PVP versus hylan GF 20, using the International Knee Documentation Committee (IKDC) score, 6 months after treatment. Hypothesis to test is: If effectiveness of intra-articular collagen-PVP is not lower than hylan GF 20 treatment in knee osteoarthritis subjects, then, statistically significant difference would not exist in IKDC score mean increase among treatment groups, after six months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double-blind masking.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 40 and 80 years old
- •Osteoarthritis in the knee rated II or III (Kellgren-Lawrence Grading Scale).
- •Pain intensity (MOS Pain Severity Scale) greater than
- •Subject able to understand, co-operative and reliable.
- •Written informed consent.
排除标准
- •Acute arthritis in the knee.
- •Ongoing anticoagulant therapy.
- •Skin infection at the injection site.
- •Systemic or intraarticular (target knee) corticosteroids in the past 3 months.
- •Viscosupplementation (target knee) in the past year
- •Arthroscopy/osteotomy/surgery in the past 5 months (target knee).
- •Any surgery scheduled in the next 6 months
- •Concomitant rheumatic disease (rheumatoid arthritis, spondyloarthritis, systemic lupus erythematosus, fibromyalgia).
- •Severe varus/valgus deformity (>15°).
- •Frontal deformity greater than 20 degrees
- •History of allergy or hypersensitivity to hyaluronic acid or avian proteins
- •History/present evidence of: metabolic joint diseases; crystal arthropaties; ochronosis; acromegaly; haemochromatosis; Wilson's disease; primary osteochondromatosis; heritable disorders.
研究组 & 干预措施
Collagen-PVP
Collagen-polyvinyl pyrrolidone (collagen-PVP).
干预措施: Collagen-PVP (Drug)
Hylan G-F 20
Hylan G-F 20.
干预措施: Hylan G-F 20 (Device)
结局指标
主要结局
International Knee Documentation Committee (IKDC).
时间窗: Evaluation will be conducted at Baseline and 6 months after first infiltration
Change from Baseline in International Knee Documentation Committee (IKDC) subjective score at 6 months. The IKDC subjetive form is a patient-reported outcome, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items).The IKDC is scored by summing the scores for the individual items and then transforming the score to a scale that ranges from 0 to 100 (add the score for each item and divide by the maximum possible). The transformed score is interpreted as a measure of function such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with activities of daily living or sports activities and the absence of symptoms.
次要结局
- Change in Pain Intensity(Evaluation will be conducted at Baseline, 2 months, 3 months and 6 months after first infiltration)
- Changes in Urine Collagen Type II C-telopeptide Fragments(Evaluation will be conducted at Baseline, and 6 months after first infiltration)
- Change in quality of life: EQS-5D(Evaluation will be conducted at Baseline, 2 months, 3 months and 6 months after first infiltration)