A Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of a Single Injection Cross-Linked Sodium Hyaluronate to Provide Symptomatic Relief of Osteoarthritis of the Knee
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 369
- 试验地点
- 62
- 主要终点
- Percentage of Subjects Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score (ITT) >=40% and 15 mm From Baseline Through 12 Weeks
研究概览
简要总结
The purpose of this study is to determine whether intra-articular injection of Monovisc® hyaluronic acid provides symptomatic relief of osteoarthritis of the knee.
详细描述
This randomized, double-blind, placebo controlled prospective study will assess the safety and effectiveness of a single intra-articular injection of Monovisc® in providing symptomatic relief of pain caused by idiopathic osteoarthritis (OA) of the knee as compared to a placebo comparator injection of sterile saline.
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)
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
- •Male or Female
- •Age 35 to 75 years
- •Body Mass Index (BMI) 20 to 40 kg/m2
- •Willing and able to provide informed consent
- •Willing to limit analgesic use to acetaminophen 7 days prior to and 12 weeks after injection
- •Not pregnant or lactating
- •Previous conservative treatment regimen for osteoarthritis (OA)
- •Diagnosis of idiopathic OA of the index knee
- •OA symptoms for >= 6 months
- •Index knee Kellgren-Lawrence (K-L) grade of II or III
- •Index knee Baseline Summed WOMAC Pain Score >= 200mm and < 400mm after NSAID washout
- •Contralateral Knee K-L grade 0, I or II
- •Contralateral Knee Baseline WOMAC Pain Score < 150mm after NSAID washout
排除标准
- •Joint disorders which could interfere with treatment effectiveness
- •Joint disorders which could interfere with study assessments
- •Arthroscopy of either knee within 3 months of screening
- •Open surgery of index knee within 12 months of screening
- •Open surgery of contralateral knee within 3 months of screening
- •Injection of Hyaluronic Acid (HA) in either knee within 6 months of screening
- •Injection of steroid in index knee within 3 months of screening
- •Any pre-treatment contraindication for injection or aspiration of the index knee, including cutaneous infection, intra-articular infection, knee deformity or condition which may jeopardize sterility or delivery of injection
- •Synovial fluid aspirate volume > 20 milliliters (mL)
- •Visual appearance of synovial fluid that contraindicates injection
- •Index knee range of motion < 90 degrees
- •Subject participation in other research study within 30 days of screening
- •Subject unwilling to maintain active lifestyle, exercise program and body weight similar to that during 3 months prior to screening for duration of study
- •Unwilling to maintain constant dosage of oral glucosamine or chondroitin sulfate for duration of study, if applicable
- •Other medication or treatments that could interfere with study injection or assessments
- •Allergy to gram positive bacterial products or intolerance of acetaminophen
- •Active fibromyalgia
- •Peripheral neuropathy severe enough to interfere with evaluation of either knee
- •Vascular insufficiency severe enough to interfere with evaluation of the subject
- •Hemiparesis involving either lower extremity
- •Systemic bleeding disorder
- •Other conditions which may adversely affect the success of the procedure
结局指标
主要结局
Percentage of Subjects Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score (ITT) >=40% and 15 mm From Baseline Through 12 Weeks
时间窗: 12 Weeks
The primary endpoint measures the percentage of subjects (Monovisc vs. saline) who achieved \>= a 40% improvement (reduction) in the WOMAC Pain Score and show at least 15 mm improvement (reduction) in the WOMAC Pain Score from baseline through 12 weeks. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score is a validated scale from 0 to 100 mm, where a higher score is equal to a higher pain level. The primary endpoint uses the ITT population that has data available for both baseline and 12 week time points.
次要结局
- Evaluator Global Assessment Change From Baseline Through Week 12 (ITT)(12 Weeks)
- WOMAC Physical Function Score Change From Baseline Through Week 12 (ITT)(12 Weeks)
- Patient Global Assessment Change From Baseline Through Week 12 (ITT)(12 Weeks)
- Range of Motion Change From Baseline Through Week 12 (ITT)(12 Weeks)