Does Arthrocentesis and PRP For Acute ACL Tears With Hemarthrosis Decrease Inflammatory Cytokines At Time Of Surgery: A Prospective Randomized Control Trial (RCT)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Concentration of Collagen Type II Cytokine
研究概览
简要总结
The purpose of this study is to determine what effects the withdrawal of excess knee joint fluid or the injection of a factor from the blood has on swelling after a sudden anterior cruciate ligament (ACL) rupture of the knee.
详细描述
The body responds to different stresses by releasing factors in the blood and fluids in response to stressors like injury, surgery or certain treatments. Some of these factors help heal and some make the injury and body swell (inflammation). In this study we want to see if the intervention of withdrawing fluid the knee or the addition of an enriched healing factor called platelet rich plasma (PRP) injected in the knee influences the body to produce healing factors in the knee joint fluid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 50
- •English-speaking
- •Clinical evidence of ACL rupture with swelling
- •Participant must be undergoing ACL reconstruction surgery
排除标准
- •Age <18 or >50
- •Presentation >3 weeks after initial injury
- •Previous traumatic ipsilateral (same side) knee injury consistent with chronic ACL tear or prior ACL surgery
- •> Kellgren-Lawrence grade 2 changes on preoperative x-ray
- •History of hemophilia or inflammatory arthropathy (e.g., rheumatoid arthritis)
研究组 & 干预措施
Two Synovial Fluid Withdrawals
Subjects randomized to Arm 1 will have 2 synovial fluid withdrawals; one at the preoperative clinic visit and one at the time of surgery
干预措施: Synovial Fluid withdrawal at the preoperative clinic visit (Procedure)
Two Synovial Fluid Withdrawals
Subjects randomized to Arm 1 will have 2 synovial fluid withdrawals; one at the preoperative clinic visit and one at the time of surgery
干预措施: Synovial fluid withdrawal at the time of surgery (Procedure)
Platelet-Rich Plasma (PRP) and Two Synovial Fluid Withdrawals
Subjects randomized to ARM 2 will have 2 synovial fluid withdrawals one at the preoperative visit and one at the time of surgery. Platelet-Rich Plasma (PRP) preparation and injection will happen at the preoperative clinic visit.
干预措施: Synovial Fluid withdrawal at the preoperative clinic visit (Procedure)
Platelet-Rich Plasma (PRP) and Two Synovial Fluid Withdrawals
Subjects randomized to ARM 2 will have 2 synovial fluid withdrawals one at the preoperative visit and one at the time of surgery. Platelet-Rich Plasma (PRP) preparation and injection will happen at the preoperative clinic visit.
干预措施: Platelet-Rich Plasma (PRP) preparation and injection (Procedure)
Platelet-Rich Plasma (PRP) and Two Synovial Fluid Withdrawals
Subjects randomized to ARM 2 will have 2 synovial fluid withdrawals one at the preoperative visit and one at the time of surgery. Platelet-Rich Plasma (PRP) preparation and injection will happen at the preoperative clinic visit.
干预措施: Synovial fluid withdrawal at the time of surgery (Procedure)
3mL Synovial Fluid Withdrawal and Synovial Fluid Withdrawal at the Time of Surgery
Subjects randomized to Arm 3 will have 3mL withdrawal of synovial fluid at the preoperative visit and 1 synovial fluid withdrawal at the time of surgery
干预措施: Synovial fluid withdrawal at the time of surgery (Procedure)
3mL Synovial Fluid Withdrawal and Synovial Fluid Withdrawal at the Time of Surgery
Subjects randomized to Arm 3 will have 3mL withdrawal of synovial fluid at the preoperative visit and 1 synovial fluid withdrawal at the time of surgery
干预措施: 3mL synovial fluid withdrawn at the preoperative visit (Procedure)
结局指标
主要结局
Concentration of Collagen Type II Cytokine
时间窗: Enrollment up to surgery
Breakdown cytokine found in damaged cartilage
次要结局
未报告次要终点