Intra-Articular Injections of Platelet-Rich Plasma in Knee Osteoarthritis: Unique Application Versus Triple Application
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Change in the Western Ontario and McMaster Universities (WOMAC) Ostearthritis Index (Therapeutic Effect)
研究概览
简要总结
The investigators include patients attending the outpatient clinic in the area of Orthopedics and Traumatology of the investigators hospital with a diagnosis of knee osteoarthritis, which treatment is medical. Patients will be divided into two groups. In both groups, they will be given verbal, clear and detailed information on the approach to follow, the intra-articular application of Platelet-Rich Plasma in the knee, plus rehabilitation exercises. In the first group will be held single application, while in the second group three applications will be made at an interval of two weeks each. Both groups will be assessed before and after application, together with outpatient follow-up by the SF-12 Health Survey (SF-12), Western Ontario and McMaster Universities Arthritis Index (WOMAC) and Visual Analogue Scale (VAS).
详细描述
Osteoarthritis (OA ) refers to a clinical syndrome of joint pain with a multifactorial etiology , with the gradual loss of articular cartilage, osteophytosis formation, subchondral bone remodeling and inflammation of the joint. Is the most common cause of knee pain, and one of the leading causes of disability and dependence of the adult population that generates large expenditures in the area of health.
The clinical diagnosis of OA is primarily clinical - radiological, based on a complete medical history and physical examination directed. No laboratory studies are routinely requested since there is no specific diagnostic test or pathognomonic for diagnosis. Physical examination is most important.
The ideal treatment is a multidisciplinary one, and must meet the objectives of achieving anesthesia, reduce disability and improve joint function and patient's quality life, with low toxicity of drugs. Several conservative treatments are recommended by clinical guidelines. Some nonpharmacologic measures are: patient education, exercise, weight loss, modification of footwear, using the local cryotherapy, acupuncture and electromagnetic therapy. Drug therapy can be summarized in paracetamol, NSAIDs, opioids, and slow-acting drugs. If these oral drugs do not work can be administered intra-articularly (corticosteroids, viscosupplementation products, and blood derivates).
Platelet-Rich Plasma (PRP) is a rich source of growth factors such as Platelet-derived growth factor (PDGF), transforming growth factor β (TGF- β ), vascular endothelial growth factor (VEGF), like growth factor type I insulin (IGF- I), vascular endothelial growth factor (EGF), among others. For these growth factors are released, the platelets need to be activated by substances such as calcium chloride, calcium gluconate or thrombin. Once activated , growth factors are secreted, reaching a peak concentration 10 minutes. It is known that GF, PDGF and TGF -B stimulate chondrogenesis helping solving clinical manifestations of patients studied.
The investigators include patients attending the outpatient clinic in the area of Orthopedics and Traumatology of our hospital with a diagnosis of knee osteoarthritis, which treatment is medical. Patients will be divided into two groups. In both groups, they will be given verbal, clear and detailed information on the approach to follow, the intra-articular application of Platelet-Rich Plasma in the knee, plus rehabilitation exercises. In the first group will be held single application, while in the second group three applications will be made at an interval of two weeks each. Both groups will be assessed before and after application, together with outpatient follow-up by the SF-12, WOMAC and Visual Analogue Scale.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 90 years
- •Patients with no previous treatment
- •Patients with Knee osteoarthritis grade 1-2 ( Kellgren-Lawrence based on radiographic findings)
排除标准
- •Age <18 and > 90 years
- •Patients with Knee osteoarthritis grade 3-4 ( Kellgren-Lawrence based on radiographic findings)
- •Patients with asociated Rheumatic syndromes
- •Patients with anticoagulant therapy
- •Patients with hepatic problems, Diabetes Mellitus, Coagulopathy, hearth conditions, immunodepressed, or infections
- •Pregnant patients
- •Patients with prosthetic or orthotic.
- •Patients with hemoglobin values < 11g/dl , platelets < 150,000/μL
研究组 & 干预措施
Triple application of PRP
Patients will be applied a triple application of platelet-rich plasma for knee osteoarthritis, with a interval of two weeks between each, and will be given rehabilitation exercises at home
干预措施: Platelet-Rich Plasma (Biological)
Unique application of PRP
Patients will be applied a unique application of platelet-rich plasma for knee osteoarthritis, and will be given rehabilitation exercises at home
干预措施: rehabilitation exercises (Behavioral)
Triple application of PRP
Patients will be applied a triple application of platelet-rich plasma for knee osteoarthritis, with a interval of two weeks between each, and will be given rehabilitation exercises at home
干预措施: rehabilitation exercises (Behavioral)
Unique application of PRP
Patients will be applied a unique application of platelet-rich plasma for knee osteoarthritis, and will be given rehabilitation exercises at home
干预措施: Platelet-Rich Plasma (Biological)
结局指标
主要结局
Change in the Western Ontario and McMaster Universities (WOMAC) Ostearthritis Index (Therapeutic Effect)
时间窗: Baseline,3 weeks, 6 weeks, 12 weeks, 24 weeks
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. It measures five items of pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68); thus, the total score range is 0-96. A higher value indicates a worst outcome. Only the final measures (at 24 weeks) are presented as part of the final analysis.
次要结局
- Change in the Visual Analog Scale (VAS) (Global Pain)(Baseline,3 weeks, 6 weeks, 12 weeks, 24 weeks)
- Change in the SF-12 Health Survey (Quality of Life)(Baseline,3 weeks, 6 weeks, 12 weeks, 24 weeks)
研究者
FELIX VILCHEZ CAVAZOS
Dr. med. Jose Felix Vilchez Cavazos
Universidad Autonoma de Nuevo Leon
