Effect of Genicular Arteries Embolization in Symptomatic Knee Osteoarthritis LipioJoint-2
Recruiting
Phase 3
Interventional Study
Knee Osteoarthritis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 40 – 90
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 130 (estimated)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Diagnosis of primary KOA according to the classification of the American College of Rheumatology (ACR) (5)
* Radiographic Kellgren and Lawrence score ≥ 2 (6)
* VAS pain score ≥ 40 mm (scale 0-100 mm)
* Previous intra-articular injection in the target knee
* Patient not eligibl…
Contacts