Effect of Genicular Arteries Embolization in Symptomatic Knee Osteoarthritis LipioJoint-2
Key facts
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Where
- France3 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 130 people, planned
- Started
- 30 Sept 2024
- Expected to end
- 1 Oct 2028
- Type of study
- Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- Ethiodized Oil-based emulsion
- Sham-operation
- Record updated
- 15 October 2024
Who can take part
- Age
- 40 years to 90 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 26 criteriaShow less
Who can take part
- 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 eligible to knee surgery
- For woman of childbearing potential: negative bêta-HCG before randomization
- Social security affiliation
- Signed informed consent
- Good understanding of the French language
Who cannot take part
- Intra-articular injection of any product in the target joint within 3 months before embolization
- Prior knee surgery other than ligament repair
- Current treatment with cyclosporine, tacrolimus, cisplatine, vancomycine, amphotericine B or any aminoside
- Asthma attack in the 8 days before randomization
- Exploration or treatment with radioactive iodine scheduled within 1 month after randomization
- Any inflammatory joint disease other than osteoarthritis
- Known severe allergy to Lipiodol® and/or iodine contrast medium
- Known right-to-left cardiac shunt or intra-tumoral vascular shunt
- Known moderate to severe kidney failure (creatinine clearance < 30 45 ml/min)
- Any contra-indication to puncture of the ipsilateral femoral artery
- Ipsilateral symptomatic hip OA
- Treated hyperthyroidism
- Symptomatic atheromatous lesion in the ipsilateral limb
- Patient unable or unwilling to comply with the follow-up schedule (at the investigator's discretion)
- Vulnerable populations (such as pregnant or breastfeeding women, patient under guardianship curatorship, deprived of liberty)
- Patient under exclusion period in another trial
- Patient on AME (state medical aid)
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 90 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Embolization groupTreatment being tested
Genicular arteries embolization of the target knee will be performed using an ethiodized oil-based emulsion (3:1 mix of ethiodized oil and contrast agent ioversol 300 mgI/ml); 86 patients will be allocated to embolization group (2:1 randomization).
Treatment: Ethiodized Oil-based emulsion
- Sham groupSham treatment, for comparison
All the gestures will be mimed using the same equipment as in GAE group. Superficial femoral artery catheterization, selective catheterization of target arteries and emulsion injection will be mimicked by the interventional radiologist (table movements, syringes manipulation) to keep the patient blind from the actual treatment. 44 patients will be allocated to sham group (2:1 randomization).
Treatment: Sham-operation
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Randomized Sham-controlled, Multicenter Trial on the Effect of Genicular Arteries Embolization in Symptomatic Knee Osteoarthritis
- Fit questions
- Built from NCT06497140, who can take part
- Record updated
- 15 October 2024