Comparison of two hyaluronic acid formulations for safety and efficacy (CHASE) study in knee osteoarthritis: a multicenter, randomized, double-blind, 26-week non-inferiority trial comparing Durolane to Artz

Table 1 Demographics and baseline clinical characteristics (per-protocol set)

	Artz	Durolane
	( n = 158)	( n = 161)
Age (years)
Number	158	161
Mean (standard deviation)	60.4 (7.75)	60.2 (8.06)
Minimum; maximum	42; 78	40; 78
Sex (female)	127 (80.4)	119 (73.9)
Body mass index classification
Underweight	0 (0.0)	1 (0.6)
Normal range	76 (48.1)	81 (50.3)
Overweight	69 (43.7)	65 (40.4)
Obese	13 (8.2)	14 (8.7)
Duration of disease (months)
Number	157	161
Mean (standard deviation)	47.7 (57.59)	47.2 (63.15)
Median	22.2	17.6
ACR criteria
Significant knee pain most days during the last 3 months	158 (100%)	161 (100%)
Age >50 years	147 (93.0%)	147 (91.3%)
Morning stiffness <30 minutes	129 (81.6%)	127 (78.9%)
Crepitus on motion	141 (89.2%)	148 (91.9%)
Surgical history
Intra-articular steroid injection	5 (3.2%)	5 (3.1%)
Intra-articular hyaluronic acid injection	28 (17.7%)	36 (22.4%
Arthroscopy and/or other surgical procedure	8 (5.1%)	4 (2.5%)
No treatment	122 (77.2%)	118 (73.3%)
X-ray examination
II: definite osteophyte, unimpaired joint space	95 (60.1%)	94 (58.4%)
III: moderate diminution of joint space	63 (39.9%)	67 (41.6%)
Likert-type WOMAC subscales^a
Pain (range 0 to 20)	9.5 (1.80)	9.4 (1.98)
Physical function (range 0 to 68)	22.7 (8.00)	22.3 (8.38)
Knee stiffness (range 0 to 8)	3.1 (1.77)	2.8 (1.73)
Global self-assessment^b (range 0 to 10)	4.3 (2.06)	4.3 (1.97)

Data presented as number, n (%) or mean (standard deviation) unless stated otherwise. Durolane from Q-med AB (Sweden) and Artz from Seikagaku Corporation (Japan). ACR, American College of Rheumatology; WOMAC, Western Ontario McMasters University Osteoarthritis Index. ^aLower scores better. ^bHigher scores better.