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

NCT06497140 | Recruiting Phase 3 DMC

• 3 other identifiers: APHP230828PHRC-22-00332023-508844-24-00
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 3

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.

Conditions

Knee Osteoarthritis

Keywords

Embolization; Pain; Randomized sham-controlled trial

Outcome Measures

Primary Outcomes (1)

• Change of pain assessed by a Visual Analogue Scale (VAS) at 3 months compared to randomization.

  VAS pain is a validated, self-reported instrument assessing average pain over the past 48 hour period. Score ranges from 0 (no pain) to 100 (worst possible pain).

  3 months

Secondary Outcomes (15)

• Change of pain assessed by a Visual Analogue Scale (VAS) at 1 month compared to randomization.

  1 month

• Change of pain assessed by a Visual Analogue Scale (VAS) at 6 months compared to randomization.

  6 months

• Change of pain assessed by a Visual Analogue Scale (VAS) at 12 months compared to randomization.

  12 months

• Change of the patient's global assessment of her/his health measured by the Visual Analogue Scale of EQ-5D questionnaire (EQ VAS) at 1, 3, 6, 12 months compared to randomization.

  Up to 12 months

• Change of the Western Ontario and McMaster Universities Arthritis (WOMAC) total and sub-scores (pain, function,stiffness) at 1, 3, 6, 12 months compared to randomization.

  Up to 12 months

Study Arms (2)

Embolization group

EXPERIMENTAL

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).

Drug: Ethiodized Oil-based emulsion

Sham group

SHAM COMPARATOR

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).

Procedure: Sham-operation

Interventions

Ethiodized Oil-based emulsion DRUG

Embolization of genicular arteries

Embolization group

Sham-operation PROCEDURE

Mimicked catheterization and embolization of genicular arteries

Sham group

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Ministry of Health, France: collaborator

Study Sites (3)

Hôpital Saint Antoine - APHP

Paris, 75012, France

RECRUITING

Hôpital Cochin - APHP

Paris, 75014, France

RECRUITING

Hôpital européen Georges Pomidou - APHP

Paris, 75015, France

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc SAPOVAL, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Touria EL AAMRI

CONTACT

0140271848; touria.el-aamri@aphp.fr

Cléo BOURGEOIS

CONTACT

0156095638; cleo.bourgeois@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the personal of the Interventional Radiology department of HEGP (only unblinded center) will have the knowledge of the trial arm. Patient will be blinded from randomization arm using headphones and/or virtual headset. The research personnel will be trained accordingly and will keep a separate file with patient's images to ensure that they are not transferred on the Pacs system (Carestream). The research assistant will discard the products after completion of the procedure in specific containers, that will not be accessible to the patient or to nurses and technicians directly involved in the current patient's care. Patient's blindness will be assessed using a blinding index after GAE and at the 3-month follow-up visit. The proposed blinding index is scaled to an interval of -1 to 1, 1 being complete lack of blinding, 0 being consistent with perfect blinding and -1 indicating opposite guessing which may be related to unblinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, single-blind, multicenter trial comparing GAE using an ethiodized oil-based emulsion with a sham procedure in patients with symptomatic knee osteoarthritis. Randomization in a 2:1 ratio of GAE using an ethiodized oil-based emulsion to the sham procedure will be performed with stratification on Kellgren and Lawrence score (2-3 versus 4).

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 11, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Two years after the last publication
• Access Criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Teams wishing obtain IPD must meet the sponsor and PI team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR).

Locations

FR (3)