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

NCT ID: NCT06497140

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2028-10-01

Brief 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.

Detailed 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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Embolization group

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).

Group Type: EXPERIMENTAL

Ethiodized Oil-based emulsion

Intervention Type: DRUG

Embolization of genicular arteries

Sham group

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).

Group Type: SHAM_COMPARATOR

Sham-operation

Intervention Type: PROCEDURE

Mimicked catheterization and embolization of genicular arteries

Interventions

Ethiodized Oil-based emulsion

Embolization of genicular arteries

Intervention Type: DRUG

Sham-operation

Mimicked catheterization and embolization of genicular arteries

Intervention Type: PROCEDURE

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 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)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc SAPOVAL, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Saint Antoine - APHP

Paris, , France

Site Status: RECRUITING

Hôpital Cochin - APHP

Paris, , France

Site Status: RECRUITING

Hôpital européen Georges Pomidou - APHP

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Touria EL AAMRI

Role: CONTACT

touria.el-aamri@aphp.fr

0140271848

Cléo BOURGEOIS

Role: CONTACT

cleo.bourgeois@aphp.fr

0156095638

Facility Contacts

Jérémie SELLAM, MD

Role: primary

jeremie.sellam@aphp.fr

0149282520

François RANNOU, MD

Role: primary

francois.rannou@aphp.fr

0158412587

Marc SAPOVAL, MD

Role: primary

marc.sapoval2@aphp.fr

0156093740

Carole DEAN, PhD

Role: backup

carole.dean@aphp.fr

0156093719

Other Identifiers

PHRC-22-0033

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2023-508844-24-00

Identifier Type: CTIS

Identifier Source: secondary_id

APHP230828

Identifier Type: -

Identifier Source: org_study_id