NCT02197026已完成4 期
A Multicentre, Open-label and Randomized Clinical Trial to Compare in Patient With Knee Osteoarthritis the Medicoeconomic Benefits as Well as Effectiveness and Safety of Synvisc® Versus Usual Treatments.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 518
- 主要终点
- Cost of knee OA treatment including cost of side effect related to OA treatment
研究概览
简要总结
Comparison of treatment cost of knee osteoarthritis (OA) in patients treated with Synvisc® versus usual treatments as well as evaluation of safety and effectiveness of these treatments.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatient aged at least 18 years
- •Patient suffering from predominant femoro-tibial knee osteoarthrosis with or without effusion. The diagnosis must be based on American College of Rheumatology (ACR) criteria. Radiological grade will be assess according to Kellgren-Lawrence scale
- •Assessment of pain on active movement (i.e. walking) (by the patient) must be at least 40 mm on a 100 mm VAS
- •Patient who received at least two courses of at least ten days within the last three months with non-steroidal antiinflammatory drugs (NSAID) and/or who are treated continuously for the last two month with slow-acting anti-osteoarthritis drugs
- •Patient's informed written consent obtained in accordance with French legislation
排除标准
- •Patient suffering from acute congestive osteoarthritis flare of the target knee (at the time of inclusion) which means that concomitantly to knee effusion at least 2 of the following criteria are present:
- •nocturnal disturbances due to knee pain
- •morning stiffness over 45 minutes
- •increase of knee pain more than 50% within the last week
- •articular reddening
- •articular heat
- •Intra-articular administration of hyaluronic acid in the target knee within the previous year
- •Intra-articular administration of hyaluronic acid in the target knee within the three previous months
- •Any other intra-articular injection in the target knee within the last 6 months
- •Any contraindication to intra-articular injections
- •Present or past history of infected target knee joint
- •Previous prosthesis knee surgery, tibial osteotomy, synovectomy or synoviorthese of the target knee
- •Arthroscopy, articular lavage, debridement, menisectomy of the target knee within the previous year
- •Planned knee surgery within the nine following month
- •Any other musculoskeletal disorders that can interfere with osteoarthritis diagnosis or the evaluation of its severity
- •Known hypersensitivity to avian products
- •Presence of lymphatic or venous stasis
- •Pregnancy or breastfeeding
- •Clinical evidence of or known severe cardiac, hepatic, renal, metabolic, haematological disease, mental disturbance
- •Participation in another clinical trial during this study or during the previous month
- •Previous participation in this trial
- •Patient who requires help concerning shopping or house keeping
- •Patient unable to comply with the protocol (e.g. patient unable to attend each trial visit or to fill the diary booklet or the quality of life questionnaire)
研究组 & 干预措施
Synvisc group
Experimental
injection of Synvisc® at day 1, day 8 and day 15; in the mean time it will be recommended to decrease or stop all other OA treatments
干预措施: Hylan G-F 20 (Drug)
Osteoarthritis standard treatment group
Active Comparator
Treatment will be left to the discretion of the investigator who could prescribe any therapies, except viscosupplementation product
干预措施: Standard treatment (Drug)
Osteoarthritis standard treatment group
Active Comparator
Treatment will be left to the discretion of the investigator who could prescribe any therapies, except viscosupplementation product
干预措施: Physiotherapy (Procedure)
Osteoarthritis standard treatment group
Active Comparator
Treatment will be left to the discretion of the investigator who could prescribe any therapies, except viscosupplementation product
干预措施: Hydrotherapy (Procedure)
结局指标
主要结局
Cost of knee OA treatment including cost of side effect related to OA treatment
时间窗: up to 274 days
Area under the curve (AUC) Lequesne index
时间窗: Day 1, 29, 91, 182 and 274
Index of severity
次要结局
- Incidence and intensity of adverse events(up to day 274)
- Acute congestive OA flares assessed through a questionnaire(Day 1, 29, 91, 182 and 274)
- Assessment of Western Ontario and McMaster Universities (WOMAC) index by patient(Day 1, 91, 182 and 274)
- Final global assessment of efficacy by patient and investigator on a four-point verbal rating scale (VRS)(Day 274)
- Number of withdrawals due to adverse event(up to day 274)
- Patient's assessment of pain on movement and rest on a visual analogue scale (VAS) through WOMAC question 1 and 3(Day 1, 91, 182 and 274)
- Disease activity assessment by patient and investigator on a VAS(Day 1, 29, 91, 182 and 274)
- Assessment of state of health of the patients with a quality of life questionnaire (SF 12)(Day 1, 91, 182, 274)
- Final global assessment of tolerability by patient and investigator on a four-point VRS(Day 274)
研究者
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