NCT01543737终止不适用
Single-blind Randomised Pragmatic Trial Comparing the Effectiveness of Two Hyaluronic Acid Viscosupplements, DUROLANE® (Single Injection) Versus HYALGAN® (Three Injections) for Symptomatic Tibiofemoral Osteoarthritis of the Knee.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 290
- 试验地点
- 17
- 主要终点
- Patients assessment of WOMAC A1 pain when walking
研究概览
简要总结
The purpose of this study is to assess whether a single injection hyaluronic acid (HA) product is not inferior to a 3 injection HA product at 24 weeks (6 months), in terms of effectiveness in reducing pain when walking in patients suffering from symptomatic tibiofemoral osteoarthritis of the knee.
详细描述
non-inferiority study of two HA products commercially availalble
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)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 40 and < 85
- •Tibiofemoral osteoarthritis of the knee according to the American College of Rheumatology clinical criteria, in the Kellgren-Lawrence (KL) stages II-III, confirmed by radiology (< 3 months)
- •Unilateral symptomatic osteoarthritis of the knee causing pain when walking (WOMAC A1 scale), assessed over the previous 24 hours on a scale of 0 to 10: Pain when walking: ≤ 3 and < 8
- •Bilateral osteoarthritis of the knee, if pain in the other knee is < 3 (10-point numerical scale)
- •Patient: outpatient, capable of walking 50 metres without a walking stick, crutches or a walker, capable of reading, understanding, signing and dating the patient information sheet
- •Patient with social security cover
排除标准
- •Osteoarthritis of the knee in Kellgren-Lawrence (KL) stages I and IV
- •Bilateral symptomatic osteoarthritis of the knee causing pain when walking (WOMAC A1 scale), assessed on a scale of 0 to 10: Pain when walking > 3, in both knees
- •Predominant symptomatic patellofemoral osteoarthritis of the knee
- •Congestive manifestation of osteoarthritis of the knee defined according to the Knee Osteoarthritis Flare-Ups Score (KOFUS) criteria
- •Last viscosupplementation of the affected knee < 6 months before, last injection of corticosteroids < 2 months before
- •Known hypersensitivity to avian proteins and hyaluronic acids;
- •History of joint replacement or major surgery in the affected knee in the last six months
- •History of arthroscopy or surgery in the affected knee in the last three months
- •Symptomatic hip disease on the same side or other side of the body
- •Joint replacement or any other surgery planned in the next six months
- •History of septic arthritis of the affected knee
- •Skin complaint affecting the knee at the injection site
- •Haemorrhagic disease contraindicating, in the doctor's opinion, any intra-articular injection
- •In order to respect the pragmatic nature of the study:
- •Any medical and / or pathological condition that, in the investigator's opinion, makes the subject unsuitable for inclusion
- •Any medical and / or pathological condition that, in the investigator's opinion, would be a contraindication for an intra-articular injection
- •Any other complaint that, in the investigator's opinion, would impede the assessment of the effectiveness of the affected knee
- •Any treatment administered to the patient that may interfere with the interpretation of the study results
- •Use of glucocorticosteroids (except inhaled corticosteroids) during the previous month
- •Treatment with diacerein, avocado and soya unsaponifiables, glucosamine sulphate or chondroitin sulphate, started in the previous 3 months, or irregular doses over the previous 3 months
- •Hard of hearing (not being able to follow a telephone conversation properly)
- •Patient without a telephone
- •Pregnant women or nursing mothers
- •Participation in other clinical studies, within 30 days before inclusion
结局指标
主要结局
Patients assessment of WOMAC A1 pain when walking
时间窗: 24 weeks
次要结局
- OMERACT-OARSI responder rate(24 weeks)
- Patient Acceptable Symptom State (PASS)(24 weeks)
- Patients assessment of WOMAC C function(24 weeks)
- Adverse events observed or spontaneously reported by patients for each treatment(24 weeks)
- Patients assessment of WOMAC A pain(24 weeks)
- Patient global assessment(24 weeks)
- Minimal Clinically Important Improvement (MCII)(24 weeks)
研究者
研究点 (17)
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