Comparison of efficacy of ultrasound guided intra-articular steroid injection in patients with avascular necrosis of femoral head-A Prospective randomized control study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- •Visual Analog Score (VAS 0–10) for pain
研究概览
简要总结
Intra-articular steroid therapy (IAST) gives a local analgesic effect and reduces inflammation for hip osteoarthritis patients. The rationale of applying IAST is joint replacement would be their only other treatment option to relieve pain and no further damage to the joint is expected. However, no published data related to the efficacy of IAST on hip avascular necrosis (AVN) of femoral head patients. Only five RCT were published on this topic, the recent being by Atchia et al in ‘2011.
A recent systemic review by Zhong et al. showed IAST had significant efficacy on hip OA in both immediate and delayed pain reduction, which persisted up to 12 weeks after IAST. The influences of the baseline severity of hip OA or synovitis and injection dose or volume on the clinical outcome of IAST are still controversial.
Our aim is
(1) To study the efficacy of intraarticular steroid injection in patients with various stages of avascular necrosis of the femoral head.
(2) To assess the duration of an objective improvement in pain and function.
(3) To determine the predictors for a clinical and radiographic response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Age more than 20 years •Diagnosis of avascular necrosis of femoral head (Ficat & Arlet – upto stage III) •Pain not relieved with conservative therapy.
排除标准
- •â€¢Diagnosis other than AVN •Uncontrolled diabetes •Cushing syndrome • Severe osteoporosis.
结局指标
主要结局
•Visual Analog Score (VAS 0–10) for pain
时间窗: Pre-intervention, 1 month, 3 months, 6 months, 1 year
•Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain/function.
时间窗: Pre-intervention, 1 month, 3 months, 6 months, 1 year
•Potential predictors of response (including radiographic severity, ultrasound synovitis and baseline symptom severity)
时间窗: Pre-intervention, 1 month, 3 months, 6 months, 1 year
次要结局
- Potential predictors of response (including radiographic severity, ultrasound synovitis and baseline symptom severity)(1m, 3m, 6m, 1y)