ISRCTN15723381进行中(未招募)未知
Genicular artEry embolisatioN in patiEnts with oSteoarthrItiS of the knee II (GENESIS II)
niversity of Reading0 个研究点目标入组 74 人开始时间: 2021年3月12日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 74
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. Participant is willing and able to give informed consent for participation in the study
- •2. Participants aged 45 years or above
- •3. Grade 3 knee OA on X-ray as per Kellgren-Lawrence (KL) Grading Scale
- •4. Knee pain for at least 3 months resistant to conservative treatment
- •5. Be able to lie flat for at least 6 hours-this will be assessed by asking how participants sleep (bed, chair recumbent, semi-recumbent) and assessing what prevents them from lying flat overnight (breathlessness, back pain, etc)
排除标准
- •1. Rheumatoid arthritis or infectious arthritis
- •2. Severe knee OA (grade 4 on x-ray as per Kellgren-Lawrence Grade)
- •3. Renal impairment: eGFR <45. Assessed from medical records or a blood test if required as is part of standard clinical practice when considering a patient for a therapeutic intervention
- •4. Patients with a bleeding diathesis, or other bleeding risk such as patients on warfarin which cannot be stopped easily (e.g. patients with metallic heart valves). assessed by asking the patient and from medical records
- •5. Requires oxygen on ambulation. assessed by asking the patient and from medical records
- •6. Low life expectancy (<1 year)
- •7. Communication difficulty due to language barriers
- •8. Contraindication to MRI
- •9. Any other significant disease or disorder which, in the opinion of the recruiting physician, may put either the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate
研究者
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