ISRCTN07329370已完成4 期
An open-label study of intra-articular steroid injection in the management of symptomatic knee osteoarthritis
Salford Royal NHS Foundation Trust (UK)0 个研究点目标入组 120 人开始时间: 2010年5月21日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age 40 - 79 years
- •2. Male or female
- •3. Ambulatory (not wheelchair bound)
- •4. Able and willing to attend or comply with intervention and follow up
- •5. Within the last 24 months:
- •5.1. Radiological (X-ray) evidence of grade 2 or more OA
- •5.2. Evidence of significant OA on MRI scan
- •5.3. Documented evidence of at least grade 2 arthritis on arthroscopy
- •6. Moderate knee pain lasting 48 hours in the past 2 weeks
- •7. Presence of clinically apparent knee effusion
- •8. Written informed consent
- •9. Glomerular filtration rate (GFR) greater than 44 ml/min
排除标准
- •1. Secondary OA - septic arthritis, gout
- •2. History of inflammatory arthritis
- •3. Previous intra-articular Ostenil or steroid injection within 6 months
- •4. Previous knee surgery (including cartilage surgery) or arthroscopy within 6 months
- •5. Inability to understand the procedures
- •6. Pregnancy
- •7. Chronic kidney disease with estimated glomerular filtration rate (eGFR) greater than or equal to 44 ml/min
- •8. Concurrent life threatening illness
- •9. Implants which prohibit safe use of MRI scan including cochlear implants/metal objects in the body including joint prosthesis, cardiac or neural pacemakers, hydrocephalus shunts, intrauterine device or coil
- •10. Known hypersensitivity to Depomedrone or any components of its excipients
- •11. Systemic infection (unless specific anti infective therapy is employed)
研究者
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