Long-term Functional Outcome of a Single Hyaluronic Acid Injection in Patients With Knee Osteoarthritis
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Functional assessment of patient with osteoarthritic knee included in this study
研究概览
简要总结
This study aims to evaluate the effectiveness of a single HA injection in improving pain, function, and quality of life in patients with knee OA over a 12-month period. By focusing on a single-arm open-label design, this study will provide practical insights into the real-world application of this treatment approach.
详细描述
Single-arm, open-label studies play a crucial role in the clinical research ecosystem. These studies are often conducted to:
- Assess the performance of a novel HA formulation (e.g., different molecular weights, cross-linking technologies).
- Gather "real-world" evidence in broader, less restrictive patient populations.
- Provide preliminary data to support the design of larger, more expensive RCTs.
- Investigate outcomes in specific patient subpopulations (e.g., severe OA, different age groups).
1. To compare mean differences VAS Score 0,1,3,6,12 months. 2. To study comparison WOMACS mean differences. 3. To document the safety and tolerability of a single HA injection in a real-world clinical setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •i. Adults aged 40-75 years with a clinical and radiographic diagnosis of knee OA (Kellgren-Lawrence grade II-III).
- •ii. Persistent knee pain (≥4 on a 10-point Visual Analogue Scale [VAS]) for at least 3 months.
- •iii. Failure to achieve adequate pain relief with conservative treatments (e.g., NSAIDs, physical therapy).
- •iv. Willingness to provide informed consent and comply with study procedures.
排除标准
- •i. Severe OA (Kellgren-Lawrence grade IV). ii. History of knee surgery or HA injection within the past 6 months. iii. Inflammatory arthritis (e.g., rheumatoid arthritis, gout). iv. Contraindications to HA injections (e.g., infection, allergy to HA products).
- •v. Significant comorbidities that may interfere with study participation (e.g., uncontrolled diabetes, morbid obesity, severe cardiovascular disease).
结局指标
主要结局
Functional assessment of patient with osteoarthritic knee included in this study
时间窗: 1 YEAR
WOMAC osteoarthritis index is going to be used to assess the functionality of the patient with osteoarthritic knee, included in the study. Assessment is done 0, 1, 3, 6,12 months
Assessment of pain score in knee osteoarthritic patient
时间窗: 1YEAR
The outcomes is measured using visual analogue score (VAS) for pain intensity assessment at 0, 1, 3, 6,12 months.
次要结局
未报告次要终点
研究者
Amran Ahmed Shokri
PROFESSOR (DR)
Universiti Sains Malaysia