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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