How Does Platelet Dose Impact Clinical Outcomes After PRP Treatment?
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Western Ontario and McMaster University's Osteoarthritis Index (WOMAC)
研究概览
简要总结
The purpose of this study is to determine which platelet rich plasma (PRP) injection dosage provides the most improvement in a patient's knee pain level at 26 weeks post-injection.
详细描述
Knee osteoarthritis (OA) is a chronic progressive disease affecting more than 20% of people older than 45 years. A myriad of different treatments have been proposed in the scientific literature, and current treatment options include conservative and surgical procedures in which the main objective is to relieve pain and improve function.
Conservative nonsurgical interventions include weight management, physical therapy, analgesics, nonsteroidal anti-inflammatory drugs (NSAIDS), corticosteroid and hyaluronic acid injections. Although these agents have been beneficial in the short term, there is a lack of evidence that such interventions alter the progression of OA. More recently, platelet-rich plasma (PRP), a biological therapy, has become an emerging treatment option to improve the status of the joint for patients with OA.
PRP is an autologous blood product that is injected into the knee joint, which contains an elevated concentration of platelets above that of whole blood. However, the optimal PRP preparation is still unknown. Studies are needed that investigate optimal platelet count and how that is related to clinical outcome.
This study is designed as a double-blind randomized controlled study, where enrolled subjects are randomized to one of five treatment groups (in blocks of 10):
- a total PRP injection dose of less than 5 billion platelets;
- a total PRP injection dose between 5 and <10 billion platelets;
- a total PRP injection dose between 10 and <20 billion platelets;
- a total PRP injection dose of >20 billion platelets; and
- a saline injection 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40-80 years of age
- •Previous diagnosis of unilateral, primary osteoarthritis of the knee
- •Knee pain; duration of symptoms > 4 weeks
- •K-L grade 0-4
排除标准
- •Under 40 years of age; over 80 years of age
- •Bilateral knee pain
- •Duration of symptoms < 4 weeks
- •NSAID or clopidogrel use in the last 7 days
- •High risk of a thrombotic event if discontinuing NSAID or clopidogrel for four weeks.
- •Steroid use in the last 6 weeks
- •Active diagnosis of leukopenia/anemia/thrombocytopenia
结局指标
主要结局
Western Ontario and McMaster University's Osteoarthritis Index (WOMAC)
时间窗: Baseline to 26 weeks post injections
Patient-reported outcome measure: The scores for each subscale are summed up, with a possible score range of 0-20 for Pain. Higher scores indicate worse pain.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
时间窗: Baseline to 26 weeks post injections
Patient reported outcome measure: Consists of 5 subscales, one of which is "Pain". A normalized score (100 indicating no pain and 0 indicating extreme pain) is calculated for this subscale.
次要结局
- Visual Analog Scale (VAS)(Baseline, 6 weeks, 12 weeks, 26 weeks post injections)
研究者
Leon Scott
Assistant Professor
Vanderbilt University Medical Center