The Efficacy of Platelets Rich Plasma Injection With PRGF Method in the Treatment for Osteoarthritis of the Subtalar Joint
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement in function and activity level in subtalar joint with osteoarthritis
研究概览
简要总结
The investigators will try to find any efficacy of platelet rich plasma injection for the treatment of osteoarthritis (OA) in the subtalar joint. Autologous platelet-secreted growth factors (GFs) may have therapeutic effects in OA capsular joints via multiple mechanisms. The investigators aim is to examine the effect of a platelet-derived preparation rich in growth factors(PRGFs) in OA of the subtalar joint, using parameters of pain, function, quality of life and safety.
详细描述
The therapeutic use of autologous platelet-rich plasma (PRP) constitutes a relatively new biotechnology that has been a breakthrough in the stimulation and acceleration of soft-tissue and bone healing In this process PRGF (preparation rich in growth factors) combines the advantage of an autologous fibrin clot that will aid in hemostasis as well as provide growth factors in high concentrations to the site of a tissue defect. The platelet-rich plasma preparation encourages the release and slow delivery of growth factors from harvested platelets, activated by endogenous thrombin, and is used as a biological enhancer in the healing of fractures, lumbar fusions, cartilage defects, muscle tears and tendon lesions, thus promoting initiation and early maturation of bone and soft tissue formation which involves a more physiologic repair with less scar tissue.
Few tubes of whole blood are drowning from the patient in a sterile manner and go through a process of centrifugation and laboratory separation of the different plasma fractions. Then, to derive benefit from the described natural mechanism, Ca2+ is added to plasma enriched in platelets, triggering the formation of a fibrin matrix containing embedded platelets. The resulting PRGF allows the slow release of biologically active proteins that initiate and modulate wound healing in both soft and hard tissues .
The objective of this clinical trial is to evaluate the symptomatic efficacy of PRGF application in the treatment of OA of the Sub-Talar joint.
base on that knowledge here is the protocol briefly:
1st visit: Enrollment of patient
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female age 18-70
- •Diagnosed OA of subtalar joint
- •Patients who didn't benefit from other conservative treatments
- •Patients who are willing to participate in the trial
- •Exclusion criteria:
- •Non ambulatory
- •Pregnant or lactating women
- •Patient with containment disease that may affect joint
- •Patient with open wounds; or skin disease; suspected joint infection: in the treated area
- •Patients with a specific condition or poor general health status that will interfere with the functional assessments during the study or who had intraarticular injection or have had surgery within the previous 3 months
排除标准
- 未提供
结局指标
主要结局
Improvement in function and activity level in subtalar joint with osteoarthritis
时间窗: 1 year
function and activity levels -be leveled according to ANKLE HINDFOOT SCORE 1-100
improvement in pain in subtalar osteoarthritis
时间窗: 1 year
pain will be leveled according to VAS SCORE:1-10 POINTS (10 THE MOST IN PAIN)
次要结局
未报告次要终点