Status:
COMPLETED
Safety and Efficacy of a Lipiodol Emulsion for the Embolization of Hypervascularizations in Patients With Knee Pain (LipioJoint1)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Guerbet
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
35-90 years
Phase:
PHASE1
Brief 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 o...
Detailed Description
It is a Phase 1, Single-Arm, Open-label, Multicenter Interventional Prospective Study. In order to ensure the best possible patient safety, a sequential inclusion of the first 6 patients is planned. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2022
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04733092
Start Date
March 3 2021
End Date
September 20 2022
Last Update
August 3 2023
Active Locations (1)
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1
Hôpital européen Georges Pompidou
Paris, France, 75015