Effect of Genicular Arteries Embolization in Symptomatic Knee Osteoarthritis
NCT Number: NCT06497140
Acronym: LIPIOJOINT-2
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Knee Osteoarthritis
Interventions: DRUG: Ethiodized Oil-based emulsion|PROCEDURE: Sham-operation
Sponsor: Assistance Publique - Hôpitaux de Paris
Collaborators: Ministry of Health, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 130
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2028-09-01
Locations: Hôpital Saint Antoine - APHP, Paris, 75012, France|Hôpital Cochin - APHP, Paris, 75014, France|Hôpital européen Georges Pomidou - APHP, Paris, 75015, France

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.

Primary Outcome Measures: 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 Outcome Measures: Change of pain assessed by a Visual Analogue Scale (VAS) at 1 month 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)., 1 month|Change of pain assessed by a Visual Analogue Scale (VAS) at 6 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)., 6 months|Change of pain assessed by a Visual Analogue Scale (VAS) at 12 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)., 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., EQ-5D questionnaire is a validated, self-reported instrument assessing "today" health-related quality of life. EQ VAS is the second part of EQ-5D, consisting in a Visual Analogue Scale of health. Score ranges from 0 (worst health) to 100 (best health)., 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., WOMAC questionnaire is a validated, self-reported instrument assessing the daily condition of patients with osteoarthritis of the lower limb. It has a multidimensional scale comprising 24 items grouped into three dimensions: pain (5 items), stiffness (2 items), and physical functioning (17 items).

Likert scale will be normalized to 100. Scores ranges from 0 (no impairment) to 100 (severe impairment)., Up to 12 months|Change of the Knee injury and Osteoarthritis Outcome Score (KOOS) total and sub-scores at 3 months compared to randomization., KOOS questionnaire is a validated, self-reported instrument assessing the daily condition of patients with osteoarthritis of the lower limb. It has a multidimensional scale comprising 42 items grouped into five dimensions: pain (9 items), symptoms (7 items), activities of daily living function (17 items), sport and recreation function (5 items), quality of life (4 items).

A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included.

Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures., 3 months|Change of the Hospital Anxiety and Depression (HAD) score and sub-scores at 3 months compared to randomization., HAD questionnaire is a validated, self-reported instrument assessing the levels of anxiety and depression. It has a multidimensional scale comprising 14 items grouped into two dimensions: anxiety (7 items), and depression (7 items). Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. Total score ranges from 0 (no impairment) to 42 (severe impairement). A total sub-scale score of \>8 points out of a possible 21 denotes considerable symptoms of anxiety or depression., 3 months|Change of semi-quantitative MRI scoring at 6 months compared to randomization., Semi-quantitative MRI scoring may include Whole-Organ Magnetic Resonance Imaging Score (WORMS), Knee Osteoarthritis Scoring System (KOSS), Boston-Leeds Osteoarthritis Knee Scoring (BLOKS), MRI Osteoarthritis Knee Score (MOAKS)., 6 months|Description of pain medication at Month 1, 3, 6, 12., Pain medication will be described using analgesic level., Up to 12 months|Description of non-pharmacological treatments for target knee in both groups at 1, 3, 6, and 12 months., Non-pharmacological interventions may include, but are not limited to, physiotherapy, osteopathy, acupuncture, massage, electroanalgesia, laser therapy, low-level light therapy, meditation., Up to 12 months|Number of responder patients under OMERACT-OARSI definition in both groups at 3, 6 and 12 months., A patient is defined as responder under OMERACT-OARSI criteria if one of the following conditions is satisfied:

* Improvement in pain (0-100 mm VAS) or in WOMAC function score ≥50% and absolute change ≥20 is observed or
* Improvement in at least 2 of the 3 following conditions:

  * Pain (0-100 mm VAS) ≥20% and absolute change ≥10
  * WOMAC function score ≥20% and absolute change ≥10
  * Patient's global assessment of her/his health (0-100 mm EQ-5D VAS) ≥20% and absolute change ≥10, Up to 12 months|Number of patients reaching an acceptable symptom state (PASS) in both groups at 3, 6, and 12 months., PASS is defined for each patient reported outcome as:

* Pain (0-100 mm VAS) ≤32.3,
* Patients global assessment of her/his health (0-100 mm EQ-5D VAS) ≤32,
* WOMAC function score (0-100) ≤31., Up to 12 months|Number and description of adverse events and serious adverse events at 1, 3, 6 and 12 months., Adverse events are defined according to Article 2 of the Regulation (EU) No 536/2014. Intensity of adverse events will be graded using Clavien-Dindo classification and CTCAE v 5.0., Up to 12 months|Description of target knee events in both groups at 6 and 12 months., Events of interest includes intra-articular injections, embolization, surgery., Up to 12 months|Incremental efficiency of genicular arteries embolization compared to sham treatment (medico-economic analysis)., Medico-economic study: incremental cost utility ratio, 6 months