A Randomised Control Trial of the Use of an Intraarticular Hydrogel Arthrosamid® vs. Steroid for the Non-operative Management of Knee Osteoarthritis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Western Ontario and McMaster Universities Arthritis Index (WOMAC).
研究概览
简要总结
This study will be a randomised control trial of the use of intra-articular Arthrosamid® a novel intraarticular hydrogel vs. standard of care (steroid and local anaesthetic) for the non-operative management of knee osteoarthritis.
详细描述
The authors aim is to study the effect of this intra-articular medication by randomising approximately 100 patients to the treatment arm of the study Arthrosamid, and 100 patients to the control arm (which will be the current standard of care currently provided at CNOH: intra-articular steroid and bupivacaine).
Patients will be referred from Orthopedic clinics and will be eligible if have symptomatic knee pain and arthritis show on prior imaging.
Patients will be given information about the study and given time to choose to be enrolled. They will sign consent forms prior to the study.
They will be randomized into 2 groups. Both will get single knee joint injections into 1 knee. Either Arthrosamid or intra-articular steroid and bupivacaine. They will be blinded to what they have gotten. They will be followed up at 3, 6 , 12 and 18 months with MRI imaging and functional assessment to assess which is better.
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)
盲法说明
Patients blinded to treatment,
Radiologists not blinded to which drug they are giving as they are prepared in distinct different ways.
Radiologists reporting the MRI of the knee is blinded and will not to know which patient got what injection.
Investigator using the data will be blinded with each patient given a unique identifier number.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Symptomatic single side knee pain.
- •Patients with diagnosis of knee osteoarthritis radiographic Kellgren and Lawrence system OA grade II-III-IV on x ray or MRI.
排除标准
- •Inflammatory conditions,
- •acute infection,
- •pregnancy and breastfeeding.
- •Uncontrolled diabetes mellitus,
- •Joint diseases in the knee, such as rheumatoid arthritis or gout, history of knee surgery with metallic implant.
- •If patient has undergone knee arthroscopy in past 6 months.
- •Intra-articular injection of corticosteroids during the previous 3 months, intra-articular injection of other drugs, such as hyaluronic acid over the previous 1 year.
- •Contraindications for intra-articular injection, such as thrombocytopenia, coagulopathy, articular infection of knee, impairment of immunity.
研究组 & 干预措施
Arthrosamid
Patient with knee osteoarthritis
Arthrosamid Injection. This is a non-biodegradable 2.5% iPAAG injectable implant. It is given once.
干预措施: Arthrosamid® 2.5% iPAAG injectable implant (Device)
Steroid
Patient with knee osteoarthritis
Steroid arm is as follow with one injection containing:
Dexamethasone 8mg and methylprednisolone 80mg and bupivacaine 0.25% 5 mls.
干预措施: Steroid Drug (Drug)
结局指标
主要结局
Western Ontario and McMaster Universities Arthritis Index (WOMAC).
时间窗: Before the onset of treatment, then 3, 6, 12 months after with possibility of follow up 18 months.
Self-administered questionnaire (24 items) assessing pain, stiffness, and physical function in patients with hip or knee osteoarthritis. Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
次要结局
- Visual numerical pain rating scale (VNS)(Before the onset of treatment, then 3, 6, 12 months after with possibility of follow up 18 months.)
- EuroQol-5 Dimension-5 Level health questionnaire.(Before the onset of treatment, then 3, 6, 12 months after with possibility of follow up 18 months.)
- MRI knee(Before the onset of treatment, then 3, 6, 12 months after with possibility of follow up 18 months.)
- EQ-5DL Health Questionnaire(Before the onset of treatment, then 3, 6, 12 months after with possibility of follow up 18 months.)
研究者
Sean-Tee Lim
Radiology Registrar
Cappagh National Orthopaedic Hospital