The Effect of Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Pain
研究概览
简要总结
This is a non-surgical trial comparing the clinical and functional outcomes of patients with osteoarthritis treated with Intra-articular injection of Micro Fragmented Adipose Tissue versus conventional therapy of intra-articular injection of corticosteroid.
详细描述
This study will be a randomized controlled trial to compare outcomes between intra-articular injection of Micro Fragmented Adipose Tissue and intra-articular injection of corticosteroid in patients with mild to moderate osteoarthritis of the knee. Micro Fragmented Adipose Tissue will be harvested at the subcutaneous tissue by lipoaspiration. Once fat tissue is obtained, it will be processed with minimal manipulation in the clinic room.
To be considered for participation in this study, patients must have radiographic evidence of mild to moderate osteoarthritis of medial and/or lateral weight-bearing compartments (Kellgren-Lawrence Grade 2 or 3). In addition, patients must meet several inclusion/exclusion criteria to be randomized and included in this study.
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
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 35 and 75 years-old
- •Diagnosis of pre-existing osteoarthritis of the joint by Kellgren-Lawrence Grade 2 or
- •Working understanding of the English language and able to fully understand the procedure
- •Capable of providing informed consent
- •Able to complete online, in-person or phone surveys for the purposes of follow-up
- •Capable of understanding pre- and post-procedure care instructions
- •Ambulatory at baseline
- •Previous trial and failure of conservative therapy consisting of a minimum of 6 weeks of physical therapy and trial of anti-inflammatory medications if not contraindicated, with or without concomitant bracing and/or injections.
排除标准
- •Age < 35 or > 75 years old
- •Radiographs demonstrating either no, little or severe osteoarthritis (Kellgren-Lawrence Grade 0, 1 )
- •Prior total or partial joint replacement surgery or a surgery involving cartilage regeneration (microfracture, ACI, etc)
- •Previous cortisone and/or Hyaluronic acid intra-articular injection within the last 3 months
- •Co-morbidity with rheumatologic condition, inflammatory arthritis
- •Currently undergoing immunomodulatory therapy
- •Uncontrolled endocrine disorder
- •Current diagnosis of osteomyelitis, human immunodeficiency virus (HIV-1, -2) and/or hepatitis C (HCV), infection and poorly controlled diabetes (HgA1C >7.0)
- •Pregnancy or planned pregnancy
- •previous stem cell injection into treatment joint
- •Patient scheduled to undergo any concomitant surgical procedures.
- •Coagulopathy or anticoagulant treatment
- •Chronic pain involving multiple body parts or opioid medication management
研究组 & 干预措施
MFAT(Micro Fragmented Adipose Tissue)
Intra-articular knee injection of autologous Micro Fragmented Adipose Tissue harvested from the thigh using tumescent lipoaspiration and processing with minimal manipulation. This harvested tissue will then be injected into the patient's knee.
Micro Fragmented Adipose Tissue: Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection
干预措施: Micro Fragmented Adipose Tissue (Biological)
Conventional therapy
Intra-articular injection of corticosteroid (Triamcinolone 40mg).
Corticosteroid injection: Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid.
干预措施: Corticosteroid injection (Biological)
结局指标
主要结局
Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Pain
时间窗: Baseline, 3, 6, 12, and 24 months
Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms).
Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Symptoms
时间窗: Baseline, 3, 6, 12, and 24 months
Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms).
次要结局
- Lysholm Score(Baseline, 3, 6, 12, and 24 months)
- Veterans RAND 12 (VR-12) Score - Physical(Baseline, 3, 6, 12, and 24 months)
- Veterans RAND 12 (VR-12) Score - Mental(Baseline, 3, 6, 12, and 24 months)
研究者
Eugene Roh
Director, Sports Ultrasound Medicine, Orthobiologics
Stanford University