Changes in Cytokines After Masked Intraarticular Injection of Dextrose or Aspiration Only in Stage IV Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Short term change in cytokine levels
研究概览
简要总结
Twenty participants with severe arthritis will be enrolled. For the first week participants will either be injected with dextrose or just have fluid withdrawn for testing. The remaining participants will be given dextrose injection at the end of the week. After one week dextrose injections will be given at one, two, three, four, five, and six months. Fluid will be withdrawn from the knee at time zero, one week, and three months. The hypothesis is that dextrose injection will cause a change in proteins in the knee consistent with improved repair signals, along with improving knee pain and function. .
详细描述
Participants with stage IV knee osteoarthritis will be evaluated for eligibility and randomized 1 to 1 using an Internet randomization method to ensure random allocation.
At time zero all participants will receive aspiration of their knees from the suprapatellar pouch of 5.5 mL of synovial fluid for cytokine analysis. After that 10 of the participants will receive injection of 10 mL of 12.5% dextrose. The other 10 will receive no injection after aspiration. Pain levels will be measured at time zero, 15 minutes, two hours and 48 hours after aspiration with or without injection to gather information about the time course of analgesia.
At one week all participants will receive aspiration of 2.0 mL from the suprapatellar pouch for cytokine analysis, followed by injection of the remaining 10 participants with dextrose 12.5%. Pain levels will be measured at the same time intervals to complete evaluation of dextrose analgesia.
After two weeks injections will be open label with 10 mills of dextrose 12 and have percent injected at one, two, three, four, five, and six months. At the three month. Another 2 mL of synovial fluid will be sent to the laboratory for cytokine analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Masking only of above.
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Knee pain for at least 6 months.
- •Clinically diagnosed knee osteoarthritis.
- •Weight-bearing radiograph consistent with high-grade medial compartment cartilage loss (Kellgren-Lawrence Grading Scale level IV).
- •Confirmation of exposed subchondral bone by high-resolution knee ultrasonography.
排除标准
- •Anticoagulation therapy.
- •Inflammatory or post-infectious knee arthritis.
- •Systemic inflammatory conditions.
- •Knee flexion of less than 100 degrees.
- •Knee extension of less than 165 degrees.
- •Any Valgus
- •Varus more than 15 degrees.
- •Any knee injection in the past 3 months.
- •BMI more than 40
- •Gross synovial folds on ultrasound
- •Elevation of sed rate, C reactive protein, rheumatoid factor or antinuclear antibody.
研究组 & 干预措施
Dextrose 0. Aspiration 1 week.
Dextrose injection given at time 0, at 1 week aspiration only, and then open label injection of dextrose at 0, 1, 2, 3, 4, 5, and 6 months.
干预措施: Dextrose 0 (Drug)
Dextrose 0. Aspiration 1 week.
Dextrose injection given at time 0, at 1 week aspiration only, and then open label injection of dextrose at 0, 1, 2, 3, 4, 5, and 6 months.
干预措施: Aspiration 1 (Drug)
Aspiration 0. Dextrose 1 week.
Aspiration only at time 0. Dextrose injection given at 1 week, and then open label injection of dextrose at 0, 1, 2, 3, 4, 5, and 6 months.
干预措施: Aspiration 0 (Drug)
Aspiration 0. Dextrose 1 week.
Aspiration only at time 0. Dextrose injection given at 1 week, and then open label injection of dextrose at 0, 1, 2, 3, 4, 5, and 6 months.
干预措施: Dextrose 1 (Drug)
结局指标
主要结局
Short term change in cytokine levels
时间窗: Obtained at baseline and 1 week
Change in cytokine levels from baseline to 1 week
Long term change in cytokine levels
时间窗: Obtained at baseline and 3 months
Change in cytokine levels from baseline to 3 months
次要结局
- Post Injection Short Term Pain Course(0, 15 minutes, 2 hours, and 48 hours after time 0 and 1 week injections)
- WOMAC score(Obtained at baseline, 3 and 6 months.)
研究者
Gaston Andres Topol
Gaston Topol, M.D., Principal Investigator
Fisiatria y Traumatología