NCT04045431已完成不适用
A Multi-centre Randomized, Controlled, Double-blind Clinical Investigation of Intra-articular Polyacrylamide Hydrogel in Subjects With Knee Osteoarthritis Followed by an Open Label Extension Study
Contura3 个研究点 分布在 1 个国家目标入组 238 人开始时间: 2019年5月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 238
- 试验地点
- 3
- 主要终点
- Comparing one injection of PAAG-OA with one injection of Synvisc-One on pain over 6 months in subjects with knee osteoarthritis
研究概览
简要总结
This is a multi-center, randomized, double-blind clinical investigation to compare the effectiveness of intra-articular polyacrylamide hydrogel (PAAG-OA) and a hyaluronic acid, Synvisc-One to induce symptomatic benefit in subjects with knee osteoarthritis.
详细描述
The trial is designed as a multi-center, randomised, controlled, double-blind, and parallel-group trial spanning over 12 months with outcome assessments at baseline, 1, 3, 6 and 12 months incl. follow-up period between 2-5 years. Primary endpoint at 6 months. The trial is designed to compare effectiveness and safety of injection of PAAG-OA and Synvisc-One® in participants with knee OA.
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, Investigator)
盲法说明
The subject and study staff will not know the treatment received. Only the unblinded injector will know the treatment.
入排标准
- 年龄范围
- 40 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 ≥ 40 years
- •Clinical diagnosis of knee OA American College of Rheumatology criteria confirmed by radiology
- •Definite radiographic OA in the most symptomatic knee (target knee) at mild to moderate-stage (Kellgren-Lawrence grades 2 or 3)
- •Stable dose of analgesics for the past four weeks
- •NRS (11 points (0-10) pain intensity numerical rating scale) ≥ 4 in target knee, during the past week when walking
- •Body Mass Index (BMI) between 20-35
- •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
- •Contraindications to PAAG-OA or Synvisc-One®, according to IB or Instruction for Use (IFU)
- •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
- •Other diseases in target knee than osteoarthritis
- •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
- •Infected or severely inflamed knees
- •History of sepsis in any joint or any clinical concern for a subacute 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 or lymphatic stasis present in the legs
- •Clinically apparent tense effusion or inflammation in the target knee
- •Suffering from any unstable or severe cardio-vascular disease
- •Any contraindication to intra-articular e.g. anticoagulant therapy or clinical concern for potential coagulopathy (e.g. liver disease)
- •Any foreign material in the target joint
- •Any significant medical condition (e.g. significant psychiatric or neurological disorders or active alcohol/drug abuse), any medical condition that is unstable/poorly controlled or other factors that may interfere with study participation
- •Treatment with systemic steroids
- •History of drug/alcohol abuse, mental dysfunction of other factors limiting their ability to cooperate fully
- •Change in physiotherapy within the previous month
- •Fibromyalgia
- •Inflammatory or other disease/condition which may affect joints (e.g. rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis among others)
- •Haemophilia
- •Any other condition that in the opinion of the investigator put a potential participant at risk or otherwise precludes participation in the trial
- •Known allergic reactions to components of Synvisc-One (avian protein)
- •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
研究组 & 干预措施
Synvisc-One
Active Comparator
Intra-articular injection with Synvisc-One (hyaluronic acid)
干预措施: Synvisc-One (Device)
PAAG-OA
Experimental
Intra-articular injection with PAAG-OA (polyacrylamide hydrogel)
干预措施: PAAG-OA (Device)
结局指标
主要结局
Comparing one injection of PAAG-OA with one injection of Synvisc-One on pain over 6 months in subjects with knee osteoarthritis
时间窗: 6 months
Change in WOMAC (WOMAC Osteoarthritis Index) pain subscale. Pain is reported in each of five response categories (0=none, 4=extreme)
次要结局
- PGA (Patient Global Assessment)(1, 3, 6 and 12 months)
- WOMAC(1, 3, 6 and 12 months)
- EQ-5D-5L, QoL(1, 3, 6 and 12 months)
- OMERACT-OARSI responder criteria(1, 3, 6 and 12 months)
研究者
研究点 (3)
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