Effect of Different Injection Regimens of Autologous Conditioned Plasma for the Treatment of Symptomatic Knee Osteoarthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Western Ontario and McMaster University's Osteoarthritis Index (WOMAC)
研究概览
简要总结
The clinical efficacy of hyaluronic acid or corticosteroid injections has been reported, but effects are short lived. This has led to the development of additional injection options such as autologous derived blood products which have been documented to alleviate symptoms related to knee osteoarthritis, with recent comparative studies suggesting a greater, long-lasting effect with these blood derived products like platelet rich plasma (PRP) [2-8]. One clinically-developed preparation of platelet rich plasma, named autologous conditioned plasma (ACP), has randomized controlled trial data proving efficacy [4,9]. Clinical use of platelet rich plasma for knee arthritis typically involves a 3-injection series over 3 weeks, i.e. an injection once a week for three weeks. The main objective of this study is to determine if hyaluronic acid (HA) injected at the same time as autologous conditioned plasma (ACP), a leukocyte-poor platelet rich plasma product, will improve the performance of ACP in the treatment of symptomatic knee osteoarthritis. It is hypothesized that the injection of hyaluronic acid will improve the efficacy of ACP.
详细描述
Patients between the ages of 30 and 80 who have documented radiographic evidence of OA in the tibiofemoral or patellofemoral compartment of the target knee (Kellgren-Lawrence grades 1-4) will be screened for participation in this study. Patients must have a documented diagnosis of primary OA for at least six weeks. 80 patients will be recruited through the Andrews Institute physician practices. The study design will be a randomized control trial. Participants who meet the inclusion criteria will have the study explained in detail, and informed consent will be obtained as outlined above. Participants will complete patient-reported outcome questionnaires prior to their injection. The questionnaires will include the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC), Knee Injury and Osteoarthritis Outcome Score (KOOS). Participants will also complete these questionnaires at 1, 3, 6, 12, 18, and 24 months after the final injection. A trained medical professional will draw blood from the patient's arm, and the blood will be spun in a centrifuge for 5 minutes at 1500 RPM. The platelets will then be separated for injection into the patient's knee. The treating physician will then inject the ACP into the involved knee joint following standard aseptic technique per the physician's standard of care. This entire process will be completed in a single patient visit. Any unused portion of a sample in the physician's office will be disposed of through standard biohazard waste disposal systems as required by law. Group 1 [ACP]: Will receive three intra-articular injections of autologous conditioned plasma dosed once a week for three weeks. Group 2 [ACP-HA]: Will receive two intra-articular injections of autologous conditioned plasma and hyaluronic acid once a week for two weeks and a third injection on the third week of ACP.
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
- Single (Participant)
盲法说明
Participants will be blinded to the type of injection that they receive.
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between the ages of 30 and 80
- •Documented radiographic evidence of OA in the tibiofemoral or patellofemoral compartment of the involved knee (Kellgren-Lawrence grades 1-4)
- •Patients must have a documented diagnosis of primary OA for at least 6 weeks.
排除标准
- •Patients who have had viscosupplementation in the involved knee in the past 6 months.
- •Any patient who has had a corticosteroid injection in any joint within 3-months prior to screening will be excluded.
- •Patients with gout or rheumatologic disease will be excluded. Patients who have had a previous negative experience with HA.
- •Any patient who will have difficulty obtaining internet access, does not have an active e-mail address, or is unable to comprehend study documents or give informed consent will be excluded.
研究组 & 干预措施
Autologous conditioned plasma group
Participants in this group will receive a three-injection series of autologous conditioned plasma over the course of 3 consecutive weeks.
干预措施: Autologous conditioned plasma (Biological)
Autologous conditioned plasma with hyaluronic acid group
Participants in this group will receive a two-injection series of autologous conditioned plasma and hyaluronic acid (Hymovis, Fidia Pharmaceuticals) and a third injection on the third week of autologous conditioned plasma.
干预措施: Hyaluronan (Drug)
结局指标
主要结局
Western Ontario and McMaster University's Osteoarthritis Index (WOMAC)
时间窗: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months post injections
Patient reported outcome measure; The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total score. Higher scores indicate worse pain, stiffness, and functional limitations.
International Knee Documentation Committee Subjective Knee Evaluation Form
时间窗: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months post injections
Patient reported outcome measure; Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function.
Knee Injury and Osteoarthritis Outcome Score
时间窗: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months post injections
Patient reported outcome measure; A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated.
次要结局
未报告次要终点