EUCTR2020-002206-10-FR
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
- Enrollment
- 22
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-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
Exclusion Criteria
- •\-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
Outcomes
Primary Outcomes
Not specified
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