Overview

Effect of Genicular Arteries Embolization in Symptomatic Knee Osteoarthritis LipioJoint-2

Status:
RECRUITING
Trial end date:
2028-10-01
Target enrollment:
Participant gender:
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.
Phase:
PHASE3
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborator:
Ministry of Health, France