Efficacy of Autologous Micro-fragmented Adipose Tissue Intra-articular Injection for Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Visual Analog Pain Scale (VAS) Over Time
研究概览
简要总结
Knee osteoarthritis (OA) is characterized by loss of cartilage leading to instability, reduced range of motion, and functional limitations. Current treatment has various limitations so that alternative options to restore function and alleviate joint pain, with the ultimate goal of healing damaged articular cartilage are needed. Mesenchymal stem cells (MSCs) therapy has shown promising results. However, MSCs are limited by complex regulatory issues. Lipogems is a technique to harvest, process, and inject minimally manipulated adipose tissue through mild mechanical force. This procedure is enzyme free and requires no clonal expansion or manipulation. The goal of this study is to evaluate the possible benefits of reduced joint pain and increased joint functionality in patients with knee osteoarthritis after the injection of Lipogems.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age of eighteen or older
- •Diagnosis of symptomatic knee osteoarthritis
- •Radiographic evidence of knee osteoarthritis
- •Failure of conservative treatment
排除标准
- •Treatment with any intra-articular knee injection within 8 weeks before surgery
- •Any disease or condition potential to interfere study outcome
- •Under 18 years of age
结局指标
主要结局
Change in Visual Analog Pain Scale (VAS) Over Time
时间窗: Pre-op, then post-op: 1 month, 3 months, 6 months, 1 year, 2 years
Scaled pain score to assess change in a patient's knee pain over time. Pain level is marked on a 100 mm line with the 0 mm corresponding to "no pain" and the 100 mm corresponding to 10/10 pain. Using a ruler, the score is determined by measuring the distance (mm) on the 100 mm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
次要结局
- Change in the knee injury and osteoarthritis score (KOOS) Over Time(Pre-op, then post-op: 1 month, 3 months, 6 months, 1 year, 2 years)