EUCTR2010-019019-39-NL进行中（未招募）不适用
'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 OA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Erasmus MC
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria are: 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.
研究者
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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'arthrosismultifactorial chronic joint disease10023213NL-OMON34935Erasmus MC, Universitair Medisch Centrum Rotterdam20
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