Intra-Articular Polyacrylamide Hydrogel Injections Improve Pain and Function in Knee Osteoarthritis: A Multicenter Retrospective Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 387
- 试验地点
- 1
- 主要终点
- Change in Physical Function (WOMAC Function Subscale)
研究概览
简要总结
This study is designed to evaluate the effects of intra-articular injections of polyacrylamide hydrogel (Arthrosamid®) in patients with knee osteoarthritis. A total of 387 patients (593 knees) were treated across three medical centers in Türkiye.
The purpose of the study is to determine whether this injection can reduce knee pain and improve physical function in everyday life. Pain is being measured using a Visual Analogue Scale (VAS), and function is being assessed with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 40 years
- •Radiographic diagnosis of knee osteoarthritis (Kellgren-Lawrence grade 2-4)
- •Received intra-articular 2.5% polyacrylamide hydrogel injection
排除标准
- •Prior knee surgery before PAAG injection
- •Malignancy, local infection, or septic arthritis
- •Inflammatory joint disease (e.g., rheumatoid arthritis)
- •Pregnancy
- •Avascular necrosis
- •Advanced varus or valgus knee deformity
研究组 & 干预措施
Knee Osteoarthritis Patients
Patients diagnosed with knee osteoarthritis (Kellgren-Lawrence grade 2-4) who received a single intra-articular injection of 2.5% polyacrylamide hydrogel (Arthrosamid®, Contura, Denmark). Followed retrospectively for 12 months to assess pain (VAS) and function (WOMAC).
干预措施: Polyacrylamide hydrogel 2.5% intra-articular injection (Biological)
结局指标
主要结局
Change in Physical Function (WOMAC Function Subscale)
时间窗: Baseline and 12 months after injection
Physical function will be assessed using the WOMAC Function subscale (0-68; higher scores indicate worse function). Baseline values will be compared with values at 12 months after injection.
Change in Knee Pain (VAS Score)
时间窗: Baseline and 12 months after injection
Pain intensity will be measured using the Visual Analogue Scale (VAS; 0-10, with 0 = no pain and 10 = worst pain). Baseline values will be compared with values at 12 months after injection.
Change in Total WOMAC Score
时间窗: Baseline and 12 months after injection
Overall knee function and symptoms will be assessed using the WOMAC total score (0-100; higher scores indicate worse symptoms and function). Baseline values will be compared with values at 12 months after injection.
次要结局
未报告次要终点
研究者
Feza Korkusuz MD
Feza Korkusuz, MD - Professor of Sports Medicine, Hacettepe University Faculty of Medicine
Hacettepe University