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Effect of Genicular Arteries Embolization in Symptomatic Knee Osteoarthritis LipioJoint-2
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
Knee OsteoArthritis (KOA) is a common disease associated with pain and impaired function. Many patients are not relieved of their symptoms with enough efficacy by conservative treatments. Genicular Arteries Embolization (GAE) is a new minimally invasive endovascular treatment allowing symptoms relief. The investigator previously demonstrated the safety of GAE using an ethiodized oil-based emulsion for the treatment of painful knee osteoarthritis in a first-in-man single-arm clinical trial called LipioJoint-1 (clinicaltrials.gov: NCT04733092; EUDRACT: 2020-002206-10). This phase 1 study also provided encouraging evidence of GAE efficacy on knee pain and function. The purpose of LipioJoint-2 study is to assess GAE efficacy using an ethiodized oil-based emulsion for the treatment of painful knee osteoarthritis in a multicenter, prospective, randomized sham-controlled clinical trial.
Official title: A Randomized Sham-controlled, Multicenter Trial on the Effect of Genicular Arteries Embolization in Symptomatic Knee Osteoarthritis
Key Details
Gender
All
Age Range
40 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
130
Start Date
2024-09-30
Completion Date
2028-10-01
Last Updated
2024-10-15
Healthy Volunteers
No
Conditions
Interventions
Ethiodized Oil-based emulsion
Embolization of genicular arteries
Sham-operation
Mimicked catheterization and embolization of genicular arteries
Locations (3)
Hôpital Saint Antoine - APHP
Paris, France
Hôpital Cochin - APHP
Paris, France
Hôpital européen Georges Pomidou - APHP
Paris, France