Pilot Exploration of Platelet Characterization of Platelet Rich Plasma Created by Two Different Systems
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Cellular composition and quantity using Horiba Cell counter
研究概览
简要总结
The investigators would like to study the differences in the quality of Platelet Rich Plasma (PRP) between two different machines in those with knee osteoarthritis. Knee osteoarthritis means your cartilage has been worn down, and it affects your knee joint. Both machines, the APEX Biologix XCELL PRP System and the Emcyte PurePRP Supraphysiologic Concentrating System, are FDA approved, commercially available, and makes PRP. The investigators will check if the platelets in the PRP have different amounts or work differently. The investigators will also assess participants symptoms after the injection and compare the two different preparation systems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Kellgren-Lawrence (KL) Grade 1-3 knee osteoarthritis
- •Symptoms of knee osteoarthritis for at least 3 months before presentation in one knee
- •Will be able to attend and perform physical therapy
排除标准
- •Received injection therapy for knee osteoarthritis in the past 6 months
- •Have severe arthritis diagnosed in ≥1 major joint by radiology criteria
- •History of septic arthritis
- •Underwent knee surgery for osteoarthritis or osteochondral defects within 1 year before randomization (e.g., autograft or allograft surgery)
- •Have had high tibial osteotomy, partial knee replacement, patellar resurfacing, total knee replacement, or have existing surgical hardware in the knee
- •Received a platelet-rich plasma injection elsewhere in the body within the past 3 months
- •Have a platelet disorder or bleeding disorder
- •Have a rheumatologic disease, autoimmune disorder, immunocompromised status, or active history of cancer
- •Are taking chemotherapy, require regular prednisone, or require regular anti-inflammatory use
- •Are pregnant, breastfeeding, or unwilling to practice birth control during the study
- •If both knees have osteoarthritis and the other knee has KL score equal to or greater than
- •Have uncontrolled illness, physical disability, or other contraindication to aerobic exercise training
研究组 & 干预措施
APEX Biologix XCELL PRP System
Participants in this group will receive Platelet Rich Plasma made by the APEX Biologix XCELL PRP System.
干预措施: APEX Biologix XCELL PRP System (Device)
APEX Biologix XCELL PRP System
Participants in this group will receive Platelet Rich Plasma made by the APEX Biologix XCELL PRP System.
干预措施: Platelet Rich Plasma (Biological)
Emcyte PurePRP Supraphysiologic Concentrating System
Participants in this group will receive Platelet Rich Plasma made by Emcyte PurePRP Supraphysiologic Concentrating System.
干预措施: Platelet Rich Plasma (Biological)
Emcyte PurePRP Supraphysiologic Concentrating System
Participants in this group will receive Platelet Rich Plasma made by Emcyte PurePRP Supraphysiologic Concentrating System.
干预措施: Emcyte PurePRP Supraphysiologic Concentrating System (Device)
结局指标
主要结局
Cellular composition and quantity using Horiba Cell counter
时间窗: Day 1
Compare cellular composition and quantifying PRP products between EmCyte PurePRP versus APEX Biologix XCELL PRP manufacturing systems using a Horiba Cell counter.
次要结局
- Platelet Activation(Day 1)
- Patient Reported Outcomes: Western Ontario and McMaster Universities Arthritis Index (WOMAC)(Enrollment to 6 months.)
- Patient Reported Outcome: Short Form-12 Health Survey(Enrollment to 6 months)
- Activity Monitor & PRP Characteristics(Enrollment to 6 months)
- Patient Reported Outcomes: Visual Analog Scale(Enrollment to 6 months)