RecruitingPhase 3NCT06497140

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

A Randomized Sham-controlled, Multicenter Trial on the Effect of Genicular Arteries Embolization in Symptomatic Knee Osteoarthritis


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

130 participants

Start Date

Sep 30, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Ethiodized Oil-based emulsion and a procedure called Sham-operation for people with knee osteoarthritis. The study is currently recruiting participants at 3 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEthiodized Oil-based emulsion

Embolization of genicular arteries

PROCEDURESham-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

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NCT06497140


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