Functional and Clinical Outcomes of Hyaluronic Acid and Steroid Injections in Bilateral Knee Osteoarthritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- WOMAC score
研究概览
简要总结
The aim of this study is to compare functional and clinical outcomes of intraarticular injections of hyaluronic acid and steroids in patients with bilateral knee osteoarthritis. We will compare clinical and functional outcomes for each knee separately after week 6, month 3, month 6, and one year after the intervention.
详细描述
We will include patients with bilateral knee osteoarthritis (Kellgren Lawrence grades 2 and 3). On initial examination, we will measure active and passive range of flexion and extension, presence of swelling, joint effusion, VAS score for each knee separately, and WOMAC score for every knee separately. We will randomly apply hyaluronic acid injection in one knee and steroid injection in the other knee. We will repeat the same examination after week 6, month 3, month 6, and one year after the procedure. The main aim is to check whether there is a significant clinical or functional difference between two groups.
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, Investigator)
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
- •bilateral knee pain
- •same grade of osteoarthritis in both knees
- •Kellgren-Lawrence grade 2 or 3 of knee osteoarthritis
- •fully completed all follow-up examinations
排除标准
- •unilateral knee osteoarthritis
- •different grade of osteoarthritis between knees based on Kellgren-Lawrence scale
- •positive history of previous knee interventions (injections, surgery)
- •positive history of additional knee injuries (meniscus, ligament...)
研究组 & 干预措施
Hyaluronic acid injection
This arm will receive a hyaluronic acid injection in the knee joint.
干预措施: Sodium hyaluronate (hyaluronic acid) (Other)
Steroid injection
This arm will receive steroid injection in the knee joint.
干预措施: Methylprednisolone Acetate Injection (Drug)
结局指标
主要结局
WOMAC score
时间窗: One year after the intervention.
Changes in WOMAC score one year after the intervention compared to the WOMAC score at the initial examination.
VAS score
时间窗: One year after the intervention.
Changes in VAS score after one year.
Range of active knee joint flexion
时间窗: One year after the intervention.
Changes in the range of active knee joint flexion
Range of active knee joint extension
时间窗: One year after the intervention.
Changes in the range of active knee joint extension
Knee swelling
时间窗: One year after the intervention.
Presence of knee joint swelling.
Knee joint effusion
时间窗: One year after the intervention.
The presence of knee joint effusion.
次要结局
- WOMAC score after 6 weeks(6 weeks after the intervention.)
- VAS score after 6 weeks(6 weeks after the intervention.)
- Range of active knee joint flexion after 6 weeks(6 weeks after the intervention.)
- Range of active knee joint extension after 6 weeks(6 weeks after the intervention.)
- Knee swelling after 6 weeks(6 weeks after the intervention.)
- Knee joint effusion after 6 weeks(6 weeks after the intervention.)
- WOMAC score after 3 months(3 months after the intervention.)
- VAS score after 3 months(3 months after the intervention.)
- Range of active knee joint flexion after 3 months(3 months after the intervention.)
- Range of active knee joint extension after 3 months(3 months after the intervention.)
- Knee swelling after 3 months(3 months after the intervention.)
- Knee joint effusion after 3 months(3 months after the intervention.)
- WOMAC score after 6 months(6 months after the intervention.)
- VAS score after 6 months(6 months after the intervention.)
- Range of active knee joint flexion after 6 months(6 months after the intervention.)
- Range of active knee joint extension after 6 months(6 months after the intervention.)
- Knee swelling after 6 months(6 months after the intervention.)
- Knee joint effusion after 6 months(6 months after the intervention.)
研究者
Edin Mešanović
Orthopedic surgeon
Cantonal Hospital Dr. Safet Mujic Mostar