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Table 2 Mean changes in secondary endpoints from baseline to follow-up visits (Per-protocol Set)

From: Efficacy and safety of single injection of cross-linked sodium hyaluronate vs. three injections of high molecular weight sodium hyaluronate for osteoarthritis of the knee: a double-blind, randomized, multi-center, non-inferiority study

  

HMWHA

XLHA

P-value

N = 111

N = 97

WOMAC

Pain subscore

Visit 5

−3.2 (3.15)

−2.77 (3.28)

0.51B

 

Visit 6

−3.87 (3.53)

−3.39 (3.64)

0.54B

 

Visit 7

−4.23 (3.7)

−3.96 (3.37)

0.59A

Function subscore

Visit 5

−8.05 (9.73)

−7.89 (10.23)

0.91A

 

Visit 6

−11.03 (11.84)

−10.74 (10.84)

0.86A

 

Visit 7

−12.09 (12.47)

−12.57 (9.58)

0.76A

Stiffness subscore

Visit 5

−0.99 (1.67)

−0.88 (1.6)

0.58B

 

Visit 6

−1.21 (1.72)

−1.18 (1.59)

0.94B

 

Visit 7

−1.34 (1.84)

−1.25 (1.59)

0.75B

Total score

Visit 5

−12.18 (13.56)

−11.54 (13.93)

0.74A

 

Visit 6

−16.02 (16.04)

−15.31 (15)

0.74A

 

Visit 7

−17.57 (17.21)

−17.77 (13.47)

0.92A

Patient’s global assessment

 

Visit 5

−15.11 (18.22)

−17.51 (23.72)

0.91B

 

Visit 6

−23.15 (21.88)

−24.64 (22.55)

0.86B

 

Visit 7

−26.91 (24.34)

−30.1 (21.75)

0.32A

Investigator’s global assessment

 

Visit 5

−21.86 (20.07)

−21.1 (22.08)

0.71B

 

Visit 6

−27.66 (19.75)

−28.24 (23.44)

0.93B

 

Visit 7

−33.23 (20.92)

−32.52 (22.89)

0.82A

100 mm VAS on pain

Rest pain

Visit 5

−12.88 (22.64)

−15.18 (24.51)

0.51B

 

Visit 6

−20.81 (22.75)

−23.1 (24.43)

0.49A

 

Visit 7

−21.69 (24.53)

−27.49 (23.69)

0.09A

Night pain

Visit 5

−15.07 (23.5)

−13.96 (23.28)

0.87B

 

Visit 6

−21.83 (26.37)

−23.93 (22.41)

0.54A

 

Visit 7

−23.28 (27.72)

−25.27 (21.16)

0.56A

Motion pain

Visit 5

−15.83 (20)

−17.06 (24.32)

0.59B

 

Visit 6

−22.67 (23.95)

−25.86 (23.46)

0.34A

 

Visit 7

−25.93 (26.59)

−29.62 (22.21)

0.28A

Range of Knee Motion (°)

 

Visit 5

135.39 (9.07)

134.02 (9.65)

0.27B

 

Visit 6

135.29 (8.88)

134.35 (9.25)

0.46B

 

Visit 7

135.71 (8.62)

134.99 (9.23)

0.51B

Swelling

 

Visit 5

18 (16.22)

22 (22.68)

0.24C

 

Visit 6

14 (12.61)

17 (17.53)

0.32C

 

Visit 7

16 (14.41)

12 (12.37)

0.67C

Tenderness

 

Visit 5

33 (29.73)

38 (39.18)

0.15C

 

Visit 6

31 (27.93)

28 (28.87)

0.88C

 

Visit 7

24 (21.62)

24 (24.74)

0.59C

  1. Data are mean (SD) except for swelling and tenderness, both of which are presented as number of patients (%)
  2. A, P-value obtained from two-sample t-test; B, P-value obtained from Wilcoxon’s rank sum test; C, P-value obtained from Chi-square test