Knee Osteoarthritis Clinical Trial
— EMBARGOOfficial title:
Symptomatic Efficacy of Microparticle Arterial Embolization in Knee Osteoarthritis Resistant to Medical Treatment: Randomized Prospective Study Versus Placebo
The aim of this double-blind, randomized, single-center prospective study (patient and evaluator) is to evaluate the efficacy of arterial occlusion (embolization) of neovessels by microparticle versus placebo on pain in disabling knee osteoarthritis at 12 months.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | December 1, 2022 |
Est. primary completion date | October 4, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - An effective contraceptive system for women of childbearing age, a pregnancy test will be offered to these women in the preoperative assessment. - Obtaining the signature of the consent to participate in the study - Kellgren-Lawrence (KL) grade 2-3 assessed by routine weight-bearing knee radiographs on the most affected knee in bilateral cases - Pain with EVA = 50 mm evolving for at least 3 months despite the start of a well-conducted medical treatment according to current recommendations including analgesics, NSAID, intra-articular injections, rehabilitation and weight loss - No surgical indication retained Exclusion Criteria: - Serious visceral failure - Local infection - Arthropathy secondary to chronic inflammatory rheumatism (rheumatoid arthritis, spondylarthritis) or microcrystalline rheumatism - History of surgery on the studied knee, except arthroscopy for more than 6 months - Gonarthrosis with KL score> 3 - Osteonecrosis of one of the bones of the knee joint on the MRI - Pregnant or lactating woman - Allergy to contrast products - Chronic or acute renal failure (clearance <30 ml / min) - Haemostasis disorders (blood platelet count <50,000 / mm3 or patient ACT / control ACT> 1,2 or PT <50%) - Operative indication of placement of a prosthesis |
Country | Name | City | State |
---|---|---|---|
France | BREUIL | Nice |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nice |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | VAS : Change of pain of the Knee injury | change in the Visual Analog Scale of Pain Intensity (VASPI). | before intervention and one month, 6 months, 12 months, 24 months and 36 months after intervention | |
Secondary | Knee injury and Osteoarthritis Outcome Score (KOOS) | KOOS questionnaire assess changes from month to month induced by treatment. KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale | at 1,6, 24, 36 month after intervention | |
Secondary | EQ-5D questionnaire | EQ-5D questionnaire is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. |
at 1, 6, 12 and 36 month after intervention | |
Secondary | Knee MRI | Knee MRI | 15 days before embolization and 12 month after | |
Secondary | Knee X-Ray | Knee X-Ray | 15 days before embolization and 12, 24, 36 month after |
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