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临床试验/NCT02923310
NCT02923310Unknown1 期

Evaluation of Two Types of PRP in Knee Osteoarthritis

University of Campinas, Brazil1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
发起方
入组人数
120
试验地点
1
主要终点
Womac

研究概览

简要总结

OOsteoarthritis (OA) is a chronic joint disease characterized by progressive degeneration of cartilage and bone tissue, leading to the appearance of subchondral cysts, osteophyte formation and synovial inflammation. Although the causes of OA are still poorly understood, biomechanical stresses able to reach the articular cartilage and subchondral bone, biochemical changes in cartilage and synovial membrane, as well as genetic factors are important items in its pathogenesis. Although there is no cure for OA, treatment is directed to each individual patient, seeking to minimize pain, maintain or improve joint range of motion and limit disability. New therapies able to accelerate regeneration and tissue repair process are being discussed. The viscosupplementation with hyaluronic acid (HA) have been shown to be an effective and safe treatment alternative in the fight against knee OA, in addition to HA, worth highlighting the therapeutic effects of growth factors derived from autologous platelets. The platelet-rich plasma (PRP) appears as an autologous therapy, non-immunogenic, able to induce healing and repair of bone soft tissue. This study aims to evaluate the clinical efficacy, comparing treatment with PRP and the combination of HA and PRP in the treatment of knee OA. To this, 120 will be selected OA patients with mild, moderate and severe (Grade II, III and IV). Selected patients will be scheduled for the procedures and randomly assigned randomly. In PRP be determined concentrations of the growth factor PDGF, TGFb 1, VEGF, EGF, by the method Bio Plex®.\. Functional evaluations will be conducted through questionnaires (WOMAC and SF-36) as measures of function and quality of self-reported life. The walking and strength test will be performed before and during periods of 90.180 and 360 days after the first application. The main motivation for the development of this study is the lack of randomized, double-blind clinical studies in the literature, and also based on the favorable results researchers have obtained, both with the use of HA, as the use of PRP in accelerating the process scar, preventing the development of arthrosis above. Therefore, we believe that the PRP, with its growth factors associated with synthetic HA play a synergistic action that should be studied in detail, in order to establish an effective therapeutic approach in the treatment of patients with knee OA.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

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

入选标准

  • Patients with Osteoarthrits

排除标准

  • diabetes, rheumatoid arthritis, axial deviation (varus> 10 degrees valgus> 10 degrees), blood disorders (coagulopathy and platelet changes), cardiovascular diseases, infections, immunosuppression, patients on anticoagulant therapy or antiplatelet use of nonsteroidal anti-inflammatory 5 days before blood collection, patients with hemoglobin concentrations <11 and platelet count <150,000 mm³.

研究组 & 干预措施

Osteoarthrits G II and III

Experimental

Group of treatment

干预措施: Platelets Rich Plasma (Biological)

Osteoarthrits G II and III

Experimental

Group of treatment

干预措施: Leucocyte - Platelets Rich Plasma (Biological)

Osteoarthrits G II and III

Experimental

Group of treatment

干预措施: Hialuronic Acid (Drug)

Osteoarthrits GIV

Experimental

Group of treatment

干预措施: Platelets Rich Plasma (Biological)

Osteoarthrits GIV

Experimental

Group of treatment

干预措施: Leucocyte - Platelets Rich Plasma (Biological)

Osteoarthrits GIV

Experimental

Group of treatment

干预措施: Hialuronic Acid (Drug)

结局指标

主要结局

Womac

时间窗: 1 year

次要结局

未报告次要终点

研究者

发起方
University of Campinas, Brazil
申办方类型
Other
责任方
Principal Investigator
主要研究者

Joyce Maria Annichino Bizzacchi

Professor

University of Campinas, Brazil

研究点 (1)

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