NCT05829798已完成不适用
An Efficacy and Safety 6-months Study of SYNOLIS VA 80/160 and SYNOLIS VA 40/80 in the Treatment of Symptomatic Knee Osteoarthritis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aptissen SA
- 入组人数
- 82
- 试验地点
- 3
- 主要终点
- Difference in Western Ontario and McMaster Universities Arthritis index (WOMAC) score total between D168 and inclusion visit
研究概览
简要总结
Multicentre, independent assessment study on SYNOLIS VA 80/160 and SYNOLIS VA 40/80 over a period of 24 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient between 35 and 75 years old
- •Patients with knee osteoarthritis. The diagnosis is based on the following American College of Rheumatology (ACR) classification:
- •Knee pain
- •Positive radiography (presence of osteophytes)
- •Morning stiffness < 30 min and/or crepitus while walking
- •Symptoms related to knee osteoarthritis for at least 6 months
- •Treatment failure (i.e. ineffective response) with analgesics and/or NSAIDs or intolerance to NSAIDs or low-grade opioids
- •Kellgren-Lawrence radiographic stage: I - III (pre-inclusion radiography)
- •WOMAC pain index score ≥ 40 mm (VAS 0-100 mm) on the knee to be treated
- •Contralateral knee pain < 10 mm (VAS) compared to treated knee
- •Patient signed inform consent form-
排除标准
- •Inability to understand the study or language used to be informed/sign the consent
- •Participation in another clinical trial within 4 weeks prior to the start of the trial, and commitment to non-participation within 4 weeks following the end of the trial
- •Intraarticular injection of hyaluronic acid in target knee within the 6 months prior to inclusion
- •Patient who has received an intra-articular (IA) or intra-muscular (IM) steroid injection within the 3 months prior to inclusion or has taken oral corticosteroids within the month prior to inclusion
- •Joint, bone, ligament, or any local or loco-regional surgery of the leg involved, arthroscopic operation on the target knee within the 3 months prior to inclusion
- •Any recent trauma to the leg involved, including a sprain, dislocation within the 3 months prior to inclusion
- •Rheumatoid arthritis, joint condition or any other inflammation and arthritis
- •Dermatological disorder or any epidermal conditions that prevent an intraarticular injection
- •Visible joint effusion of the target knee during physical examination evidenced by a protuberance or positive ballottement of the patella
- •Evidence of a subchondral fracture, meniscal lesion, presence of bone or cartilage fragments, horizontal meniscal lesion tear (FLAP) in the target knee
- •Osteonecrosis (1 or both knees)
- •Daily dosage > 101 mg of acetylsalicylic acid as part of cardiovascular preventive treatment (antithrombotic). If dose < 101 mg, must be maintained during the study
- •Known intolerance/hypersensitivity/allergy to any of the components in either product, SYNOLIS VA
- •Fibromyalgia
- •Patient of childbearing potential, pregnant or breast-feeding known at inclusion or in the planning phase during the study unless willing to use contraceptives through the whole duration of the study
- •Excessive and repeated consumption of alcohol or illicit substances
- •Any medical condition that may interfere with the proper conduct of the study (including any surgery or hospitalisation)
研究组 & 干预措施
SYNOLIS VA 80/160
Experimental
SYNOLIS VA 80/160 (hyaluronic acid 80 mg, sorbitol 160 mg) Intra-articular injection
干预措施: SYNOLIS VA 80/160 (Device)
SYNOLIS VA 40/80
Experimental
SYNOLIS VA 40/80 (hyaluronic acid 40 mg, sorbitol 80 mg) Intra-articular injection
干预措施: SYNOLIS VA 40/80 (Device)
结局指标
主要结局
Difference in Western Ontario and McMaster Universities Arthritis index (WOMAC) score total between D168 and inclusion visit
时间窗: 168 days
The Western Ontario and McMaster Universities Arthritis index (WOMAC) is a 24-item, condition-specific questionnaire available in a 5-point Likert and 100 mm visual analog scale (VAS) as well as an 11-box numerical rating scale, composed of three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). VAS was used in this study, with a score of 0 for no pain and 100 mm for the worst pain one can image)
次要结局
- Change in pain measurements, assessed using the Western Ontario and McMaster Universities Arthritis index (WOMAC) pain severity index, as compared to D0(up to 168 days)
- Percentage of subjects using analgesics(up to 168 days)
- Change in the Western Ontario and McMaster Universities Arthritis index (WOMAC) functional severity index, as compared to D0(up to 168 days)
- Change in the Western Ontario and McMaster Universities Arthritis index (WOMAC) stiffness severity index, as compared to D0(up to 168 days)
- Measurement of relief satisfaction by the patient(168 days)
- Measurement of therapeutic efficacy by the investigator (assessor)(168 days)
研究者
研究点 (3)
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