NCT02713542已完成不适用
Autologous Conditioned Plasma (ACP) Intra-articular (IA) Injections for Knee Osteoarthritis (OA)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 8
- 主要终点
- Pain Scores Measured by Western Ontario and McMaster Universities Index (WOMAC) Survey
研究概览
简要总结
This study is primarily investigating the effectiveness of Autologous Conditioned Plasma (ACP) Intra-articular (IA) in patients with Osteoarthritis (OA) in the knee.
详细描述
This study is a prospective, multi center randomized double blind, two arm study.
90 subjects will be randomized to receive injections of either Autologous Conditioned Plasma Intra-articular or the control.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject is 18 to 70 years of age.
- •The subject presents with complaints of continued pain of primary knee for at least 6 weeks.
- •The subject has documented radiographs evidence of Osteoarthritis (OA) in the tibio-femoral or patella-femoral compartment of the target knee (Kellgren-Lawrence Grades II-III), using radiographs performed within 24 weeks of screening.
- •The subject has a WOMAC pain score of at least 8 out of 20 and at least moderate pain (a score of 2) for at least 2 questions on activities
排除标准
- •Grade I and IV on the knee Kellgren-Lawrence grading scale
- •Subject has clinically 3+ effusion of the target knee (stroke test grading system).
- •Subject has significant (> 10⁰) valgus or varus deformities as evidenced by standard of care X-ray.
- •Subject has had systemic or IA injection of corticosteroids in any joint within three months prior to screening.
- •Viscosupplementation in any joint in the past six months.
- •Subject has an increased risk for post- procedure bleeding (e.g., bleeding disorder or taking anticoagulants except low-dose aspirin).
- •Subject had prior open surgery on the target knee within 12 months or knee arthroscopy within 6 months
- •Subject has inflammatory disease of either knee other than OA.
- •Subject with underlying medical conditions that could interfere with the evaluation of the outcome.
- •Subject with positive pregnancy test, or breast feeding.
- •Subject with plans to participate in other clinical trial involving medical or surgical intervention in the next 12 months.
- •Subject with any condition (including cognitive impairment) that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
- •Subject has rheumatoid arthritis or gout
- •Subject has a history of or a current infection at the affected joint.
- •Subject with plans to undergo any elective orthopedic surgery in the next 12 months.
- •Subject requires pain management therapy (with the exception of acetaminophen) not related to the target knee.
研究组 & 干预措施
Normal Saline (NS)
Placebo Comparator
3 NS Intra-articular (IA) injections at 1 week intervals
干预措施: Placebo (Other)
Autologous Conditioned Plasma (ACP)
Experimental
3 Intra-articular (IA) injections at 1 week intervals
干预措施: ACP (Device)
结局指标
主要结局
Pain Scores Measured by Western Ontario and McMaster Universities Index (WOMAC) Survey
时间窗: 6 month visit
The WOMAC Pain score will be used to measure outcome, the score ranges from 0 to 20. The higher the score indicates greater pain.
次要结局
未报告次要终点
研究者
研究点 (8)
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