Adult patients with articular or abarticular intractable pain in the knee
Conditions
Interventions
Trade Name: LIPIODOL ULTRA FLUIDE 480 mg/ml
Pharmaceutical Form: Solution for injection
Trade Name: Optiray 300 (300 mg I/mL)
Pharmaceutical Form: Solution for injection
Sponsors
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -age between 18 and 90 years included -diagnosis of primary inflammatory knee osteoarthritis defined by an osteoarthritis according to the classification of the ACR (American College of Rheumatology) and a score = 2 according to the classification of Kellgren and Lawrence -patient not eligible for surgery (or refusing surgery) -pain = 40 mm (Analog Visual Scale) despite an analgesic medication for at least 3 months -failure or intolerance of treatment with NSAIDs and/or tramadol and/or paracetamol, and/or failure or intolerance or patient unwilling a strong opioid treatment (morphinic, codeine) -failure or refusal by the patient of corticosteroid infiltration -patient who has signed an informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 7
Exclusion criteria
Exclusion criteria: -patient unable or unwilling to comply with the follow-up schedule -infiltration in target joint within the previous three months - treated hyperthyroidism -traumatic injury, hemorrhage or bleeding in the target joint within the last week -known severe allergy to Lipiodol® and/or iodized contrast medium -known severe kidney failure (creatinine clearance < 30 ml/min) -pregnant or breastfeeding woman -patient not affiliated with a French medicare -patient benefiting from legal protection -participation in another interventional study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Describe the safety of using a Lipiodol emulsion® for the embolization of inflammatory hypervascularizations in patients with articular or abarticular intractable pain in the knee.;Secondary Objective: Describe the efficacy of using a Lipiodol emulsion® for the embolization of inflammatory hypervascularizations in patients with articular or abarticular intractable pain in the knee.;Primary end point(s): The primary endpoint is the number of Serious Adverse Events imputable to embolization.;Timepoint(s) of evaluation of this end point: 1 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are the folowing : immediate technical success, reduction of pain score (Analog Visual Scale), improvement of joint disability score (WOMAC), improvement of quality of life score (SF-36), reduction of pain medication, patient satisfaction by questionnaire, adverse events and serious adverse events up to 3 months after embolization.;Timepoint(s) of evaluation of this end point: 3 months | — |
Countries
France
Contacts
Public ContactDRCI Hôpital St Louis
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Outcome results
None listed