Prospective, Open-label Clinical Investigation of Intra-articular Polyacrylamide Hydrogel Injection in Subjects With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 4
- 主要终点
- PGA
研究概览
简要总结
This is a multi-centre, prospective, open-label, uncontrolled, clinical investigation followed by an open-label extension clinical investigation to evaluate PAAG-OA in patients with knee osteoarthritis.
详细描述
This is a multi-centre, prospective, open-label clinical trial consisting of a main study followed by an extension study. The study will evaluate the effectiveness and safety of intra-articular polyacrylamide hydrogel (PAAG-OA) in subjects with knee OA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged ≥ 18 years
- •Clinical diagnosis of knee OA according to American College of Rheumatology criteria
- •Definite radiographic OA in target knee at mild to severe stage (Kellgren-Lawrence 2-4)
- •Stable dose of analgesics for the past four weeks
- •Score of 2 or more (0-4 scale) on WOMAC question A1 (pain while walking on flat surface)
- •Body Mass Index (BMI) <35
- •For females of reproductive potential: use of adequate contraception must be used throughout the trial
排除标准
- •Female participants who are pregnant, lactating or planning pregnancy during the course of the clinical investigation
- •Previous intra-articular injection of polyacrylamide gel in the target knee
- •Previous intra-articular injection with hyaluronic acid or derivatives in target knee in the previous 6 months
- •Significant valgus/varus deformity of the knee, ligamentous laxity or meniscal instability
- •Diseases in target knee other than OA
- •Intra-articular injection of any substance other than hyaluronic acid (e.g. corticosteroids) in the target knee within the last 3 months
- •Acute serious infection of any region that required hospital care or intravenous antibiotic treatment within the last 30 days, or oral antibiotic treatment within the last 14 days
- •Skin disease or infections in the area of the injection site
- •History of sepsis in any joint or any clinical concern for an infectious process in the target knee
- •History of surgery in the target knee within the past 6 months
- •Symptomatic osteoarthritis of the hips, spine or ankle, that interferes with the evaluation of the target knee
- •Planned surgery on any lower extremity
- •Clinically significant venous of lymphatic stasis present in the legs
- •Suffering from any unstable or severe cardio-vascular disease
- •Any other contraindication to intra-articular injection
- •Any foreign material in the target joint
- •Any significant medical condition (e.g. significant psychiatric or neurological disorders or active alcohol/drug abuse) that is unstable/poorly controlled or other factors that may interfere with study participation
- •Treatment with systemic steroids with daily doses equivalent of >7,5 mg prednisolone
- •Significant change in physiotherapy in lower extremities related to OA within the previous month
- •Fibromyalgia
- •Inflammatory or other disease/condition which may affect the knee joint (e.g. rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis among others)
- •Haemophilia
- •Any other condition that in the opinion of the investigator puts a potential participant at risk or otherwise precludes participation in the investigation
- •Known allergic reactions to antibiotics (azithromycin and moxifloxacin) or local anaesthesia
- •Participation in any experimental device study within 6 months prior to enrolment, or participation in an experimental drug study within 1 month prior to enrolment
结局指标
主要结局
PGA
时间窗: 1 and 3 months
To evaluate the effectiveness of one injection of PAAG-OA on knee OA Patient Global Assessment (PGA). PGA is reported on a 10 cm Visual Analogue Scale
WOMAC
时间窗: 1 and 3 months
To evaluate the effectiveness of one injection of PAAG-OA on knee OA-related subject reported symptoms, function during activities of daily living. Change in WOMAC (WOMAC Osteoarthritis Index) pain subscale where a score of 0=none, and 4=extreme
Change in the WOMAC pain subscale
时间窗: 3 months
To evaluate the effectiveness of one injection of PAAG-OA on pain over 3 months in subjects with mild to severe knee OA. Change in WOMAC (WOMAC Osteoarthritis Index) pain subscale where a score of 0=none, and 4=extreme
次要结局
- Change in WOMAC(6 and 12 months)
- Change in PGA(6 and 12 months)