NL-OMON34935已完成4 期
'Delayed gadolinium-enhanced MRI of cartilage (dGEMRIC) as an outcome measure to evaluate the effectiveness of intra-articular hyaluronic acid for knee osteoarthritis' - Suitability of MRI scan in evaluation of treatment of knee OA
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion criteria are: knee pain for more than 3 months, with a severity of the knee pain of more than 2 mm on a VAS score (range 0 to 10 mm), and radiographic signs of knee OA, defined by a Kellgren & Lawrence score of grade 1 or 2.
排除标准
- •viscosupplementation in the target knee within the last year, glucocorticoid or steroid injection into the target knee within the last three months, intra-articular procedure (arthroscopy (< 6 months), lavage, tibial osteotomy) within the last year, history of synovectomy, knee surgery scheduled within the next 4-5 months, dermatologic disorders or skin infection in proximity to the target knee, pregnant or planning to be pregnant or lactating females, poor general health status or specific condition that would interfere with functional assessments (bed ridden patients or patients in wheelchair or who are unable to walk 50 steps unaided), inflammatory arthritis, varus or valgus deformity > 12 degrees, chondrocalcinosis, presence of hip OA severe enough to affect the evaluation of function, receiving regular analgesic therapy for reasons other than painful OA of the knee, chronic use of daily (oral) steroid therapy, alcoholism, patients from whom it is not sure that they will be able to attend the follow-up measurements, insufficient command of the Dutch language, spoken and/or written,
- •Absolute and relative contra-indications for MRI: brain aneurysm clip, implanted neural stimulator, cardiac pacemaker or defibrillator, cochlear implant, ocular foreign body, other implanted medical devices: (e.g. catheters), insulin pump, metal shrapnel or bullet, metallic implant in the region of the target knee joint, pregnancy, lactating women, renal insuffiency (defined by a glomerular filtration rate of <60 milliliter/minute), allergy to contrast media
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'Delayed gadolinium-enhanced MRI of cartilage (dGEMRIC) as an outcome measure to evaluate the effectiveness of intra-articular hyaluronic acid for knee osteoarthritis’ - Efficacy of Hyaluron injections for knee OAOsteoarthritis of the kneeEUCTR2010-019019-39-NLErasmus MC
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