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Table 2 Secondary outcomes

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

Parameter

Method of analysis

Coll2-1

Decrease between inclusion (D-10) and D30 or D180

Lequesne index (LI)

Decrease between inclusion visit (D-10) and further visits

Global assessment of pain

Visual analog scale (VAS, 0–100 mm) between inclusion visit (D-10) and further visits

OMERACT/OARSI set of criteria

Percentage of responders at D90 and D180

Acetaminophen and NSAID consumption

Number of patients that required at least once rescue medication during the study

Patient’s global assessment of the disease activity

11 points Likert scale ranging of 0 (low active disease) to 10 (maximum activity)

  1. Abbreviations: OMERACT Outcome Measures in Rheumatology, OARSI Osteoarthritis Research Society International, D-10 10 days before injection, D30, D90, D180 respectively 30, 90, and 180 days following injection