Safety and Efficacy of a Lipiodol Emulsion for the Embolization of Hypervascularizations in Patients With Knee Pain (LipioJoint1)

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Knee osteoarthritis is a common cause of disability in patients who are often young and active. Surgery being an option only for the most severe cases, there is little alternative in case of failure of recommended medication. Inflammatory hypervascularization of the joint is a known source of pain. Temporary embolization of intra-arterial inflammatory hypervascularization has been used since 2012 with good results on pain relief to treat patients with musculoskeletal disorders that are resistant to conventional treatments. Lipiodol® has transient embolizing properties when in emulsion with a contrast agent. It has been used as an emulsion with chemotherapy for the treatment of metastases and primary intra-arterial liver cancer (chemo-embolization) for many years without serious side effects. We hypothesized that Lipiodol® in emulsion could serve as a temporary embolization agent for the treatment of inflammatory hypervascularization responsible for musculoskeletal disorders in humans.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Guerbet
• Treatments: Ethiodized Oil

Criteria

Inclusion Criteria:

• Diagnosis of primary inflammatory knee osteoarthritis of the target joint defined by a knee osteoarthritis according to the American College of Rheumatology (ACR) classification and a score ≥ 2 according to the classification of Kellgren and Lawrence

• Patient not eligible for surgery (or refusing surgery)

• Analog Visual Scale (VAS) pain ≥ 40 mm despite analgesic treatment for at least 3 months

• Failure or intolerance of treatment with NSAIDs and/or tramadol and/or acetaminophen, and/or failure or intolerance or patient refusing strong opioids medication (morphine, codeine)

• Failure or patient refusal of corticosteroid infiltration

• Patient who has signed an informed consent

Exclusion Criteria:

• Patient who is unable or unable to comply with the follow-up schedule

• Infiltration of target joint less than three months old

• Treated hyperthyroidism

• Traumatic injury, hemorrhage or bleeding less than 1 week old in the target joint

• Known arterial disease of the lower limbs stage ≥ 2 according to the classification of Leriche and Fontaine

• Known severe allergy to Lipiodol® and/or iodized contrast product

• 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 research