Skip to main content

Table 1 Exclusion criteria

From: Reduction of the Serum Levels of a Specific Biomarker of Cartilage Degradation (Coll2-1) by Hyaluronic Acid (KARTILAGE® CROSS) Compared to Placebo in Painful Knee Osteoarthritis Patients: the EPIKART Study, a Pilot Prospective Comparative Randomized Double Blind Trial

Related to the OA pathology  
Radiographical Kellgren and Lawrence grade I or IV
Osteoarthritis secondary to a microcrystalline arthropathy: chondrocalcinosis previously known or defined by a calcium border on at least one tibiofemoral spacing, gout ……
Isolated femoropatellar OA
Presence of another joint (other than the evaluated knee) affected by OA (confirmed in radiographs and symptomatic)
Chondromatosis or villonodular synovitis of the knee
Paget disease
Recent trauma (<1 month) of the evaluated knee
Pathologies interfering with the evaluation of OA (radiculalgia in the lower limbs, arteritis…..)
Acute inflammatory osteoarthritis (Kofus ≥ 7)
Related to previous and concomitant treatments  
Corticosteroids injection in the evaluated knee in the last month before injection
Hyaluronan injection in the evaluated knee in the last 6 months before injection
Acetaminophen and NSAIDs 48 h before inclusion visit
Change in the dosage of symptomatic slow-acting drugs i.e. chondroitin, glucosamine, diacerein or avocado-soybean unsaponifiables in the last 3 months before first injection
Arthroscopy and surgery in the target knee in the last 3 months before first injection
Oral corticotherapy
Related to associated pathologies  
Severe diseases (liver or renal failure, uncontrolled cardiovascular diseases….)
Other inflammatory rheumatic diseases (e.g. rheumatoid arthritis)
Dermatological infection at the site of injection
Anticoagulant treatment
High risk of hemorrhage
Related to the patients  
Allergy to hyaluronan and constituents (i.e. mannitol)
Allergy to acetaminophen
Pregnant or breastfeeding women
Premenopausal women without contraception
Unable to write
Participation to a therapeutic clinical trial in the last 3 months
Under guardianship or judicial protection