A Multicenter, Double-Blind, Randomized, Saline-Controlled Study of a Single, Intra-articular Injection of Autologous Protein Solution in Patients With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 332
- 试验地点
- 27
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert (LK) 3.1 Pain Subscale Change From Baseline to 12 Months
研究概览
简要总结
A double-blind, multicenter, randomized, controlled trial (RCT) that will evaluate the efficacy of a single dose of Autologous Protein Solution (APS) in patients with Osteoarthritis (OA) of the knee.
详细描述
A double-blind, multicenter, randomized, saline-controlled trial (RCT) that will evaluate the efficacy of a single dose of Autologous Protein Solution (APS) in patients with symptomatic osteoarthritis (OA) of the knee who have not been able to get satisfactory pain relief with prior treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 21 and ≤ 80 years old at the time of screening
- •Willingness and ability to comply with the study procedures and visit schedules and ability to follow oral and written instructions
- •A standing radiograph of the knee showing a Kellgren-Lawrence grade of 2 to 4 and an absence of severe osteoarthritis
- •Body Mass Index ≤ 40
- •A qualifying WOMAC LK 3.1 pain subscale total score
- •Has undergone at least one prior conservative osteoarthritis treatment
- •Signed an institutional review board approved informed consent
排除标准
- •Presence of clinically observed active infection in the index knee
- •Presence of symptomatic osteoarthritis in the non-study knee
- •Diagnosed with rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis, or arthritis secondary to other inflammatory diseases; HIV, viral hepatitis; chondrocalcinosis, Paget's disease, or villonodular synovitis
- •Diagnosed with leukemia, known presence of metastatic malignant cells, or ongoing or planned chemotherapeutic treatment
- •Untreated symptomatic injury of the index knee
- •Presence of surgical hardware or other foreign body intended to treat arthritis or cartilage-related pathology in the index knee
- •Previous cartilage repair procedure on the injured cartilage surface of the index knee
- •Arthroplasty or open surgery of the index knee within 6 months of screening
- •Intra-articular steroid injection in the index knee within 3 months of screening
- •Intra-articular hyaluronic acid injection in the index knee within 6 months of screening
- •Other intra-articular therapy in the index knee within 6 months prior to screening
- •Orally administered systemic steroid use within 2 weeks of screening
- •Planned/anticipated surgery of the index knee during the study period
- •Skin breakdown at the knee where the injection is planned to take place
- •Pregnant or nursing mothers or women planning on getting pregnant during the time they will be participating in the study
- •Participated in any investigational drug or device trial within 30 days prior to screening
- •Participated in any investigational biologic trial within 60 days prior to screening
研究组 & 干预措施
nSTRIDE APS
Autologous Protein Solution prepared using the nSTRIDE APS Kit
干预措施: nSTRIDE APS (Device)
Saline
Saline control
干预措施: Saline (Device)
结局指标
主要结局
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert (LK) 3.1 Pain Subscale Change From Baseline to 12 Months
时间窗: Baseline and 12 Months
The primary objective of this study was to determine whether nSTRIDE APS is superior to Saline with respect to the improvement in mean WOMAC Pain score (change from baseline to 12 Months post-injection raw score). The WOMAC pain subscale consisted of five questions scored from 0 to 4. The pain score has a range of 0 (no pain) to 20 (maximal pain).
次要结局
- Adverse Events(12 months)
- EQ-5D Change From Baseline to 12 Months(Baseline and 12 Months)
- Visual Analog Scale (VAS) Pain Change From Baseline to 12 Months(Baseline and 12 Months)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) LK 3.1 Stiffness Subscale Change From Baseline to 12 Months(Baseline and 12 Months)
- Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Responders(12 months)