Comparison of Efficacy of Intraosseous vs Intra-articular Injections of PRP for Advanced Knee OA
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- PROM - PAIN
研究概览
简要总结
This is a prospective cohort clinical study. Due to logistic constraints at the sites of implementation, a randomized allocation will not be feasible (private clinic). Patients will be selected with the aim of matching for important confounders (sex and age) the grade of knee OA will be restricted to advance stages.
详细描述
A prospective cohort clinical study. The matched sample will be divided into two groups. Group 1 will receive two intraosseous injections of PRP and another intra-articular injection of PRP on the same day.
Group 2 will only receive two intra-articular injections of PRP, separated by one week. One week before the PRP injection, both groups will receive an intra-articular injection of 20 mg triamcinolone hexacetonide.
The PRP is obtained from an autologous blood sample. PRP production consists of a 54 mL (PRP intra-articular) and 80 mL (PRP intraosseous) sample of venous blood from the cubital vein of the patient's upper limb, using 6 x 9 ml tubes, containing a 3.2% sodium citrate solution. The tubes will be centrifuged at 2400 rpm for 12 minutes at room temperature. It is obtained a suspended concentration of PRP that is carefully extracted using a pipette to avoid aspiration of leukocytes from the buffy coat (leukocyte-poor PRP [LP-PRP]). For group 1, it will be injected 4 mL intraosseous, and 8 mL intra-articular. Group 2 will be injected 8 ml of PRP twice (one each week). A total of 8 ml of PRP will be injected into the knee.
A hemogram will be used to analyze the blood sample and the PRP to evaluate their characteristics (concentration of red blood cells, concentration of white blood cells, concentration of platelets, and mean platelet volume); with this analysis, it will be also calculated the platelet concentration growth factor (between baseline blood sample and PRP). Besides concentration, it will also be calculated the total volume of platelets injected into the knee.
All procedures will be carried out in a laminar flow chamber (0.34 m/s) to avoid contamination. Following preparation, the PRP will be injected with the minimum time elapsed since its preparation (maximum 30 minutes).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
In this study, blinding (masking) will be applied to the outcome assessors. Patients will notice which specific type of PRP injection (intraosseous or intra-articular) they are receiving. Outcome assessors who evaluate the VAS scores, KOOS, and MRI results will also be blinded to the group assignments to prevent bias in the assessment of the results.
入排标准
- 年龄范围
- 45 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult individuals with unilateral or bilateral symptomatic knee OA diagnosis according to the American College of Rheumatology
- •with symptoms for more than 3 months
- •confirmed with radiologic diagnosis (Kellgren-Lawrence grades III or IV).
- •Patients must be able to walk with a painful knee.
排除标准
- •previous history of knee surgery
- •systemic autoimmune or rheumatic disease
- •platelet diseases
- •use of NSAIDs 3 days prior the injections
- •previous history (last 3 months) of systematic use of corticosteroids
- •or other intra-articular injections in the knee in the past 6 months
结局指标
主要结局
PROM - PAIN
时间窗: baseline, and at follow-up of 3 months, 6 months and 12 months
Visual analogic Score - PAIN (VAS) -absolute value from the score (units). Min-Max (0-10) higher scores indicate worse outcomes
PROM - Knee related Qol
时间窗: baseline, and at follow-up of 3 months, 6 months and 12 months
Knee injury and Osteoarthritis Outcome Score (KOOS) - absolute value from the score (units). Min-Max (0-100) higher scores indicate better outcomes and a higher quality of life related to the knee
次要结局
- bone marrow edema -MRI(1 month prior to the injection; 1 month to one year after intervention)
研究者
João Rocha Neves
MD, MSC, MPH, PHD, FEBVS
Universidade do Porto
