Role of Intra-articular and Intra-osseous injections of Platelet Rich Plasma in OA Knee
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Visual analogue pain Score (0-10cm)
研究概览
简要总结
Osteoarthritis (OA) Knee is a common debilitating condition, for which there is no cure. Although OA is not a life-threatening condition, the severity of this disease lies in the continuous pain and functional impairment.
It is evident from the literature, that cartilage loss is not only a pathologic process that triggers OA. Subchondral bone is identified as the starting place for pathologic changes, and cartilage is the victim of this process. In OA, the sub-chondral bone undergoes changes which include microcrack, structural defects and progressive replacement of the subchondral marrow with fibro neurovascular mesenchymal tissue. Hence, lesions in this subchondral tissue lead inevitably to the onset of OA, if they are not treated properly.
The popular biologic therapy, autologous platelet rich plasma (PRP), prepared from patients own blood, contains a pool of growth factors for cartilage repair. Biological analysis of PRP has also demonstrated an anti-inflammatory effect on the intra-articular environment. The use of platelet-rich plasma (PRP) for the treatment of osteoarthritis (OA) has demonstrated mixed clinical outcomes in randomized controlled trials.
As it is yet to establish which of the joint tissues, among synovial membranes, synovial fluid, articular cartilage or sub-chondral bones, is the primary driver of OA Knee, it is not clear whether we should target one or multiple tissues or structures during interventions. We can assume that targeting several joint tissues or structures at a time, can provide a better result.
Hence, we are planning to conduct this study to see whether the addition of intra-osseous injections of PRP directly into the subchondral bone to conventional intra-articular treatment would achieve a better positive effect in OA Knee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients aged 40-65 years, who are able to walk with a painful knee and fulfilled the criteria for knee OA of the medial femorotibial joint, as defined by the American College of Rheumatology (ACR).
- •2.Persisting Knee Pain due to OA Knee (Grade II/III, according to the radiological classification of knee OA defined by Kellgren and Lawrence) 3.Pain of at least 20 mm on a 0-100mm VAS when asked: “how painful is your knee during level walking?†4.If both knees involved, participants choose one or both knees to be treated.
- •5.Willing to participate in all assessment.
排除标准
- •Severe OA Knee (Grade IV, according to Kellgren and Lawrence classification) 2)Haemoglobin level < 10gm% 3)Inflammatory or post-infectious knee arthritis 4)History of prior knee replacement repair 5)Prior fracture of the knee joint 6)Any Knee injection within 3 months 7)Daily use of opioid medication 8)Coexisting Backache, other chronic pain disorder 9)Body mass index (BMI) greater than 40 kg/m2 10)Blood disorders, hematological, cardiac, hepatic or renal disorders.
- •Patients who had received either an oral, topical or intra-articular steroid during the four weeks before the study pregnancy 12)Co-morbidity severe enough to prevent participation in the study protocol including at-home exercise or attendance at scheduled injection appointments.
结局指标
主要结局
Visual analogue pain Score (0-10cm)
时间窗: 0 month (V1), 1.5 months (V2), 3 months (V3)
次要结局
- KOOS questionnaire (0-100)(Range of motion of affected knee joint)