Effect of Platelet Rich Plasma Injections on Inflammatory and Chondrodegenerative Biomarkers in Patients With Acute Anterior Cruciate Ligament Tears
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in Synovial Interleukin (IL) -1 Receptor Antagonist Concentration
研究概览
简要总结
A potential long-term consequence of anterior cruciate ligament injuries is the development of post-traumatic osteoarthritis in the years following injury. There are no curative treatments for osteoarthritis, increasing the importance of minimizing the occurrence of post-traumatic osteoarthritis following anterior cruciate ligament injuries. Current literature has begun to indicate that biochemical changes in the knee joint cartilage, such as chondrocyte death, following injury can contribute to the development of post-traumatic osteoarthritis.
The main objective of this study is to determine if an early intervention of joint aspiration and platelet rich plasma injection will positively affect the biomarkers representative of chondral degeneration in patients with anterior cruciate ligament injuries. We hypothesize that the intervention will reduce the volume of inflammatory and chondrodegenerative biomarkers following anterior cruciate ligament injury.
详细描述
A non-surgical treatment option for the management of osteoarthritis include injectables such as corticosteroids and platelet rich plasma. These injectables work by positively affecting cartilage cells, also known as chondrocytes, and the cells of the joint lining tissue, also known as synoviocytes. Platelet rich plasma is an autologous derived blood product, i.e. a joint injectable made from the patient's own blood at the time and location of injection with simple blood centrifugation. Studies in the bench-top laboratory setting have provided in-vitro evidence that platelet rich plasma decreases synoviocyte production of metallometal proteases, an inflammatory protein with negative effects on cartilage and decreases the effects of inflammatory proteins.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No history of previous traumatic ipsilateral knee injury
- •Bone bruise visualized on MRI
- •No clinical evidence of posterior cruciate ligament injury with no more than grade 1 medial or lateral collateral ligament injury
排除标准
- •Patients without a palpable knee effusion
- •An injury occurring more than 10 days before enrollment
- •Previous ipsilateral knee surgery
- •Intra-articular cortisone or platelet rich plasma injection into either knee within 3 months of injury
- •Participation in another clinical drug trial within the 4 weeks before injury
- •A history of any inflammatory disease or immune-comprised
研究组 & 干预措施
Control Group
The control group will have a joint aspiration performed at an initial visit (within the first 10 days after injury), and at the time of surgery (within 4 weeks of injury).
干预措施: Control Group (Other)
Experimental Group
The experimental group will have a joint aspiration performed at an initial visit (within the first 10 days after injury) and receive an injection of leukocyte poor platelet rich plasma injection in their knee. At a second visit 5-12 days after the initial visit, the patient will receive a joint aspiration and platelet rich plasma injection. A final joint aspiration will be performed at the time of surgery (within 4 weeks of injury).
干预措施: Experimental Group (Drug)
结局指标
主要结局
Change in Synovial Interleukin (IL) -1 Receptor Antagonist Concentration
时间窗: Timepoint 1: initial visit (within 10 days of injury) Timepoint 2: at the time of surgery (within 4 weeks of injury)
The presence of the Synovial Interleukin (IL) -1 Receptor Antagonist biomarker in the synovial fluid will be assessed.
次要结局
未报告次要终点