A Double-Blind, Randomized, Feasibility Controlled Study to Assess the Safety and Efficacy of MM-II, an Injectable Intraarticular Medical Device, Intended to the Treatment of Symptomatic Knee Osteoarthritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of participants with an acute inflammatory reaction in the injected knee
研究概览
简要总结
The purpose of this study is to determine whether MM-II is effective in the treatment of osteoarthritis, in direct comparison with an approved hyaluronic acid preparation.
详细描述
Osteoarthritis (OA) is the commonest form of joint disease, characterized by articular cartilage degradation with an accompanying periarticular bone response and a synovial membrane inflammation. Clinical manifestations of OA in the knee include pain in and around the joint, stiffness of the joint after rest, crepitus on motion and limited joint. MM-II medical device was designed to reduce wear and lower friction in knees of osteoarthritis patients by creating a lubricating layer onto cartilage surfaces upon injection. The purpose of this study is to determine whether a medical device MM-II is effective in the treatment of osteoarthritis, in direct comparison with an approved hyaluronic acid preparation.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic unilateral knee tibiofemoral OA
- •Radiographic evidence of knee OA of Kellgren-Lawrence Grade II or III in one or both knees on a recent 3 months time X-Ray
- •Knee pain within the last 24 hours before assessment more than 40mm on VAS
- •Pain on most days in the last month
排除标准
- •Knee pain equal or more than 80mm on a 100mm VAS.
- •Pain in the contra lateral knee; more than 30mm on a 100 VAS.
- •Concomitant inflammatory joint disease (e.g. gout, rheumatoid arthritis, history of Reiter's syndrome, psoriatic arthritis and ankylosing spondylitis.
- •Any condition that may interfere with the measure of pain in the targeted knee
- •Concomitant meaningful synovial fluid effusion
- •Post trauma OA
- •Gross ligamentous instability of the knee
结局指标
主要结局
Number of participants with an acute inflammatory reaction in the injected knee
时间窗: up to 7 days
An acute inflammatory reaction in more than 5% of the participants will be considered as manifestation of treatment related intolerance
Change from baseline in blood count
时间窗: 3 days and 7 days
Number of participants with adverse events
时间窗: Up to 90 days after the treatment
次要结局
- Maximum global pain in the target knee(Days -21, 0, 1, 3, 7, 14, 30, 90th)
- The Western Ontario and McMaster University OA index (WOMAC)(Days 0, 7, 14, 30, 90)
- The patient global assessment of treatment by Likert-scale questionnaire(Days 0, 7, 14, 30, 90)
- The patients acceptance of symptoms state (PASS)(Days 7, 14, 30, 90)
- Omeract-ORASI responders index(Days 7, 14, 30)
- The number of tablets of rescue medications used between visits(During the study)