Intra-articular Injections of Platelet-rich Plasma, Hyaluronic Acid, or Corticosteroids for Knee Osteoarthritis, Which is Better? A Prospective Study of a Single-blind Randomized Control Trial RCT From the Iraqi Population
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Timed Up and Go test (TUG)
研究概览
简要总结
To assess if there are any differences among platelet-rich plasma, hyaluronic acid, and corticosteroid knee intra-articular injection regarding function and pain.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 35-65 years old
- •Patient with knee pain that had been continuing for at least 12 months with no relief using anti-inflammatory medications and that deteriorated with weight-bearing
- •Knee osteoarthritis that classified as mild-moderate or moderate-severe (Kellgren-Lawrence Grade 2, 3, or 4)
排除标准
- •Age > 65 years
- •The recent history of knee trauma
- •Autoimmune rheumatic diseases
- •Accompanying severe hip OA
- •Thrombocytopenia or other blood diseases
- •Immunosuppressive or anticoagulant treatment
- •The invasive procedure applied to the knee
- •Intra-articular steroid injection to the knee within the previous 12 months
- •Previous joint infection
- •Uncontrolled systemic diseases such as diabetes or hypertension, and cancer
- •Excessive varus/valgus knee deformity
研究组 & 干预措施
Platelet-rich plasma arm
干预措施: Platelet-rich plasma (Biological)
Hyaluronic acid arm
干预措施: Hyaluronic acid (Drug)
Methylprednisolone acetate arm
干预措施: Methylprednisolone acetate injectable suspension (DEPO-MEDROL®) (Drug)
结局指标
主要结局
Timed Up and Go test (TUG)
时间窗: 18th months
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees
Visual Analogue Scale (VAS)
时间窗: 18th months
The VAS uses a straight 10 centimeter line with one end being 'no pain' and on the other end the 'worst imaginable pain'. The patient chooses a spot on the line then places a perpendicular line to indicate their pain level
次要结局
未报告次要终点
研究者
Usama Al-Sari
Senior Lecturer of Rheumatology M.B.,Ch.B, MSc , PhD
University of Wasit