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

Phase 1

• Conditions: Adult patients with articular or abarticular intractable pain in the knee; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2020-002206-10-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-30
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 22

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
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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified