A prospective study of the safety and efficacy of the use of a Lipiodol Emulsion for the embolization of inflammatory hypervascularizations observed in patients with articular or abarticular pain in the knee - LipioJoint 1 - LipioJoint 1

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)0 个研究点目标入组 22 人开始时间: 2020年4月30日最近更新: 2021年4月5日

试验速览

暂无简介。

•-age between 18 and 90 years included
•-diagnosis of primary inflammatory knee osteoarthritis defined by an osteoarthritis according to the classification of the ACR (American College of Rheumatology) and a score = 2 according to the classification of Kellgren and Lawrence
•-patient not eligible for surgery (or refusing surgery)
•-pain = 40 mm (Analog Visual Scale) despite an analgesic medication for at least 3 months
•-failure or intolerance of treatment with NSAIDs and/or tramadol and/or paracetamol, and/or failure or intolerance or patient unwilling a strong opioid treatment (morphinic, codeine)
•-failure or refusal by the patient of corticosteroid infiltration
•-patient who has signed an informed consent
•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 15
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 7

•-patient unable or unwilling to comply with the follow-up schedule
•-infiltration in target joint within the previous three months
•- treated hyperthyroidism
•-traumatic injury, hemorrhage or bleeding in the target joint within the last week
•-known severe allergy to Lipiodol® and/or iodized contrast medium
•-known severe kidney failure (creatinine clearance < 30 ml/min)
•-pregnant or breastfeeding woman
•-patient not affiliated with a French medicare
•-patient benefiting from legal protection
•-participation in another interventional study

发起方