NCT00556608已完成4 期
Efficacy Evaluation of Intra-articular Hyaluronic Acid (Sinovial®) vs Synvisc® in the Treatment of Symptomatic Knee Osteoarthritis. A Double-blind, Controlled, Randomised, Parallel-group Non-inferiority Study
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 381
- 试验地点
- 20
- 主要终点
- Improvement in WOMAC pain subscore from baseline
研究概览
简要总结
The purpose of this study is to prove the non-inferiority of the intra-articular injection of hyaluronic acid (Sinovial®) in the symptomatic treatment of knee OA in comparison to Synvisc®.
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, Investigator)
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
- •Age between 40 and 80 years
- •Primary knee OA of the medial or lateral femoro-tibial compartment
- •Symptoms for at least 3 months
- •Diagnosis according to ACR criteria
- •Kellgren & Lawrence radiological grade 2-3
- •Patients who failed to respond sufficiently (not responders) to analgesics and/or NSAIDs taken regularly or responders intolerant to the regular use of analgesics and/or NSAIDs.
- •Mean WOMAC pain subscore at the target knee >= 40 mm and < 80 mm on a VAS at baseline after wash-out from analgesics/NSAIDs· If bilateral knee OA: definition of the most symptomatic joint at screening based on patient's evaluation and Investigator's clinical judgment and mean WOMAC pain subscore at baseline in the contra-lateral knee < 30 mm
- •Written informed consent
- •Subject able to understand, co-operative and reliable
排除标准
- •BMI >= 32 kg/m2
- •Secondary (post-traumatic) knee OA
- •Predominantly patello-femoral pain/syndrome
- •No remaining joint space width
- •Symptomatic hip OA or other interfering health condition
- •Severe varus/valgus deformity (>15°)
- •History/present evidence of (target knee): inflammatory, infective or metabolic joint diseases; recurrent clinical chondrocalcinosis; crystal arthropaties; osteo-articular pathologies differing from arthrosis; articular fracture; ochronosis; acromegaly; haemochromatosis; Wilson's disease; primary osteochondromatosis; heritable disorders; collagen gene mutations.
- •Concomitant rheumatic disease
- •Significant injury to the target knee in the last 6 months
- •Previous joint replacement/arthroplasty (target knee)
- •Arthroscopy/osteotomy/surgery in the past 1 year (target knee)
- •Any surgery scheduled in the next 6 months
- •Venous or lymphatic stasis in the relevant limb
- •Skin infection/disease/trauma at the injection site
- •Systemic or i.a. (target knee) corticosteroids in the past 3 months
- •I.a. corticosteroids (non-target joint) in the past 4 weeks
- •Viscosupplementation (target knee) in the past year
- •Recently started (in the last 3 months) physical therapy (target knee)
- •Recently (in the last 3 months) started therapy or change in dosage of SYSADOAs
- •Ongoing anticoagulant therapy
- •Chronic or recurrent use of NSAIDs/analgesics/narcotics because of diseases different from OA of the target knee
- •History of allergy or hypersensitivity to hyaluronic acid or paracetamol or avian proteins
- •Participation in a clinical study in the last 3 months
- •Pregnant or lactating women, and women of childbearing potential not willing to use adequate contraception
- •Patients unable to stay in the study for 6 months, non-cooperating, not able to understand
研究组 & 干预措施
Sinovial
Experimental
3 intra-articular injections of Sinovial®
干预措施: Sinovial® (syringe containing sodium hyaluronate solution) (Device)
Sinvisc
Active Comparator
干预措施: Synvisc® ( syringe containing Hylan G-F 20 solution) (Device)
结局指标
主要结局
Improvement in WOMAC pain subscore from baseline
时间窗: to week 26
次要结局
- Change in WOMAC OA Index total score and pain, function and stiffness subscores;Change in Lequesne's algofunctional index; Change in global pain (visit assessment); Change in global status by the patient;Change in global status by the Investigator;SPID%(26 weeks)
研究者
研究点 (20)
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