Platelet Rich Plasma In Knee Osteoarthritis: A Prospective, Double-Blind Randomized, Placebo Controlled Clinical Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- VAS
研究概览
简要总结
The research questions of this study are;
- Is platelet rich plasma (PRP) treatment effective in knee osteoarthritis (OA)?
- What are the indications for PRP treatment?
- Which patients are the most suitable for the PRP treatment method?
- How does age, Body Mass Index (BMI), lower extremity mechanical axis angle and OA stages affect the success of the PRP treatment?
- Is there any advantage of multiple PRP doses?
- What is the therapeutic effect of placebo?
This study was designed to find answers of these questions.
The hypotheses of this study are; "PRP treatment is more effective than placebo; PRP treatment effectiveness decreases with age and advanced stages of OA; BMI is a factor that negatively affects the treatment effectiveness of the PRP; as the mechanical axis angle of the lower limb increases, it will adversely affect the effectiveness of PRP therapy; multiple dose of PRP affects the effectiveness and duration of PRP as positively compared to single dose of PRP".
The primary purpose of this study; to prove the effectiveness of PRP treatment on knee pain and functions in patients with knee OA by comparing it with the placebo control group. Secondary purposes of this study; to understand the effect of age, BMI, OA grade and lower limb mechanical axis angle on PRP effectiveness. This study, designed as a randomized, double-blind and placebo control group, with a high level of scientific evidence. Thus, it will be scientifically possible to find answers to the investigators research questions and to prove the investigators hypothesis.
详细描述
The power analysis of this study was calculated based on the sample size studies of previous studies. The difference of d = 3 units between the two means is to have a standard deviation of 6 units. The sample size 200 required to detect with 95% power in the 95% confidence interval to detect.
This study covers 324 patients. All patients were selected according to predefined and established inclusion and exclusion criteria.
Inclusion criteria were: stage 1-2-3 symptomatic OA patients according to Kellgren / Lawrence staging, age between 18 and 80 years, mean Visual Analogue Score (VAS) of >4 of 10 (worst possible pain) over the course of 7 days during the previous month were included on a voluntary basis. Only one knee injection was made to the patients.
Exclusion criteria were OA secondary to joint inflammatory diseases; patients with generalized OA, metabolic diseases of the bone, coexisting backache, the presence of hematological disease (coagulopathy), bilateral symptomatic lesions and advanced stages (grade 4) of OA; patients who had received intra-articular injections within three months or arthroscopic lavage in the previous one year or who were receiving immunosuppressive; patients with current use of anticoagulant medications or NSAIDs used in the five days before blood donation, major axis deviation (more than 15 degree of varus or more than 5 degree of valgus deviation); and patients with a hemoglobin level less than 11.5 g/dL and platelets level less than 100,000/μL or associated co-morbidities, infection, tumor, crystal arthropathies, anemia, tense joint effusion and pregnancy or possibility of pregnancy.
The voluntary patients included in this study were divided into four different groups with a computer-assisted randomization program. This groups; group A (n:67) were given a single injection of PRP, group B (n:69) were given a single injection of normal saline (physiological control/placebo), group C (n:66) were given three injection (one per month) of PRP, group D (n:65) were given three injection of normal saline (one per month) (physiological control/placebo).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stage 1-2-3 symptomatic OA patients according to Kellgren / Lawrence staging
- •mean VAS pain score of >4 of 10 (worst possible pain) over the course of 7 days during the previous month
排除标准
- •OA secondary to joint inflammatory diseases,
- •generalized OA,
- •metabolic diseases of the bone,
- •coexisting backache,
- •the presence of hematological disease (coagulopathy),
- •bilateral symptomatic lesions and advanced stages (grade 4) of OA,
- •patients who had received intra-articular injections within 3 months or arthroscopic lavage in the previous 1 year,
- •patients who were receiving immunosuppressive,
- •patients with current use of anticoagulant medications,
- •NSAIDs used in the 5 days before blood donation,
- •major axis deviation (more than 15 degree of varus or more than 5 degree of valgus deviation),
- •patients with a hemoglobin level less than 11.5 g/dL,
- •platelets level less than 100,000/μL,
- •associated comorbidities, infection, tumor, crystal arthropathies, anemia, tense joint effusion and pregnancy or possibility of pregnancy.
研究组 & 干预措施
PRP group
Intraarticular 5 ml single PRP injection
干预措施: PRP (Biological)
Saline group
Intraarticular 5 ml single saline injection
干预措施: Saline (Drug)
Multiple PRP group
Intraarticular 3 dose of 5 ml PRP injection (0, 1, 3 month injection)
干预措施: PRP (Biological)
Multiple saline group
Intraarticular 3 dose of 5 ml saline injection (0, 1, 3 month injection)
干预措施: Saline (Drug)
结局指标
主要结局
VAS
时间窗: VAS score at 24th months
Visual Analogue scale (0-10 higher scores mean a worse outcome)
Kujala
时间窗: Kujala score at 24th months
Kujala Patellofemoral Score (0-100 higher scores mean a better outcome)
KOOS
时间窗: KOOS score at 24th months
Knee injury and Osteoarthritis Outcome Score (0-100 higher scores mean a better outcome)
WOMAC
时间窗: WOMAC score at 24th months
Western Ontario and McMaster Universities Arthritis Index (0-100 higher scores mean a better outcome)
次要结局
- Knee movement(1st, 3rd, 6th, 12th and 24th months)
- mechanical axis angle(baseline)
- age(baseline)
- stage(baseline)
- BMI(baseline)
- patient global satisfaction(24 months)
- knee circumference(1st, 3rd, 6th, 12th and 24th months)
研究者
Ferhat Say
M.D. Associate Professor
Ondokuz Mayıs University