Public assistance - Paris hospitals
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.
Knee Osteoarthritis
Ethiodized Oil-based emulsion
Sham-operation
PHASE3
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.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 130 participants |
| Masking : | TRIPLE |
| Masking Description : | 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. |
| Primary Purpose : | TREATMENT |
| Official Title : | A Randomized Sham-controlled, Multicenter Trial on the Effect of Genicular Arteries Embolization in Symptomatic Knee Osteoarthritis |
| Actual Study Start Date : | 2024-09-30 |
| Estimated Primary Completion Date : | 2028-01-01 |
| Estimated Study Completion Date : | 2028-10-01 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 40 Years to 90 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Saint Antoine Hospital - APHP
Paris, France, 75012
RECRUITING
Cochin Hospital - APHP
Paris, France, 75014
RECRUITING
Georges Pompidou European Hospital - APHP
Paris, France, 75015