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

Assistance Publique - Hôpitaux de Paris

Status and phase: Enrolling; Phase 3

Conditions: Knee Osteoarthritis

Treatments: Procedure: Sham-operation; Drug: Ethiodized Oil-based emulsion

Study type: Interventional

Funder types: Other

Identifiers

NCT06497140

APHP230828

PHRC-22-0033 (Other Grant/Funding Number)

2023-508844-24-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Full description

Patients will be screened during current practice consultation in each recruiting center (Screening Visit). When a patient will meet the eligibility criteria, he will be informed about the protocol.

The Interventional Radiologist will further explain the protocol to the patient and check inclusion/non-inclusion criteria during baseline visit. The date of signature of the informed consent by the patient will be considered as the date of inclusion. GAE (embolization) will be scheduled within the next few days.

Randomization will occur during the embolization visit, before patient is taken to the operating room. Randomization in a 2:1 ratio of GAE using emulsion to the sham procedure will be performed with stratification on Kellgren and Lawrence score (2-3 versus 4). All target arteries will be injected with an ethiodized oil-based emulsion (GAE group). Patient will be kept blind to the actual treatment using headphones or virtual headset.

Follow-up visits will be scheduled 1, 3, 6 and 12 months after randomization. Patient will be informed about his randomisation group (GAE or sham) after the completion of questionnaires (VAS pain, WOMAC, EQ-5D, HAD) at the 3-month visit and will be allowed to choose further medical & clinical management of his target KOA.

Enrollment: 130 estimated patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

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 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

Exclusion criteria

• Intra-articular injection of any product in the target joint within 3 months before embolization
• Prior knee surgery other than ligament repair
• Any inflammatory joint disease other than osteoarthritis
• Any contra-indication to puncture of the ipsilateral femoral artery
• Current treatment with cyclosporine, tacrolimus, cisplatine, vancomycine, amphotericine B or any aminoside
• Ipsilateral symptomatic hip OA
• Treated hyperthyroidism
• Known severe allergy to Lipiodol® and/or iodine contrast medium
• Known moderate to severe kidney failure (creatinine clearance < 30 45 ml/min)
• Known right-to-left cardiac shunt or intra-tumoral vascular shunt
• Asthma attack in the 8 days before randomization
• Exploration or treatment with radioactive iodine scheduled within 1 month after randomization
• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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130 participants in 2 patient groups

Embolization group

Experimental group

Description:

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:

Drug: Ethiodized Oil-based emulsion

Sham group

Sham Comparator group

Description:

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:

Procedure: Sham-operation