Autologous Intra-Articular Micro-Fragmented Adipose Transfer for the Treatment of Thumb Carpometacarpal Joint Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Percent Change in Score on Pain Visual Analog Scale (VAS)
研究概览
简要总结
32 patients with Eaton-Glickel stage 2-3 CMC arthritis will be randomized to receive intraarticular MFAT or intraarticular corticosteroid injection. Patients with inflammatory arthritis or prior thumb base trauma or surgery will be excluded. Autologous adipose tissue will be harvested from the outer thigh or lower abdomen using local anesthesia. Tissue will be processed to remove oil and debris in-office using an FDA-approved commercially available device. The processed adipose will be immediately injected into the thumb CMC joint under fluoroscopic guidance. Visual analogue score (VAS), grip/pinch strength, Kapandji range of motion score, thumb disability examination, and QuickDASH score will be assessed pre-procedure and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months.
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
- 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
- 否
入选标准
- •18 years old or older; male and female patients
- •Eaton-Glickel stage 2-3 thumb CMC arthritis
- •Failed conservative treatment (i.e. hand therapy, pain medications, splinting)
- •Able to provide informed consent
排除标准
- •Pregnancy/breastfeeding
- •Inflammatory or posttraumatic arthritis
- •Prior thumb base trauma or surgery
- •Evidence of skin infection or soft tissue loss at the thumb CMC joint or adipose harvest site
- •Active local or systemic malignancy
- •Known allergy to any study drug
研究组 & 干预措施
MFAT
干预措施: Micro-Fragmented Adipose Tissue (MFAT) (Biological)
Steroid (Control)
干预措施: Triamcinolone Acetonide 10mg/mL (Drug)
结局指标
主要结局
Percent Change in Score on Pain Visual Analog Scale (VAS)
时间窗: Baseline, Month 12
Pain severity scores will be assessed by use of a visual analog scale (VAS; total range = 0-10; 0 = no pain, 10 = worst pain imaginable)
次要结局
- Change in Kapandji Range of Motion Score(Baseline, Month 12)
- Change in Score on Thumb Disability Exam (TDX)(Baseline, Month 12)
- Change in Shortened Disabilities of the Arm, Shoulder, and Hand (QuickDASH) Score(Baseline, Month 12)