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Table 2 Non-inferiority variables: mixed-effects repeated-measures results, weeks 18 and 26 (per-protocol set)

From: 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

 

Change from baseline

Treatment-related

 

Artz

Durolane

difference

(5 × 2.5 ml)

(1 × 3 ml, 4 × sham)

(Durolane – Artz)

( n  = 158)

( n  = 161)

 

Pain a

Week 18

   

 LSM (95% CI)

−5.87 (−6.23; −5.52)

−5.97 (−6.32; −5.61)

−0.09 (−0.58; 0.39)

  P value

<0.0001

<0.0001

0.7034

Week 26

   

 LSM (95% CI)

−6.05 (−6.39; −5.71)

−6.15 (−6.49; −5.81)

−0.10 (−0.56; 0.37)

  P value

<0.0001

<0.0001

0.6783

Physical function a

Week 18

   

 LSM (95% CI)

−12.10 (−12.95; −11.26)

−12.75 (−13.60; −11.91)

−0.65 (−1.81; 0.51)

  P value

<0.0001

<0.0001

0.2718

Week 26

   

 LSM (95% CI)

−12.58 (−13.39; −11.77)

−13.16 (−13.97; −12.35)

−0.58 (−1.69; 0.53)

  P value

<0.0001

<0.0001

0.3054

Global evaluation b

Week 18

   

 LSM (95% CI)

2.55 (2.33; 2.77)

2.70 (2.48; 2.92)

0.15 (−0.15; 0.45)

  P value

<0.0001

<0.0001

0.3319

Week 26

   

 LSM (95% CI)

2.67 (2.45; 2.88)

2.81 (2.59; 3.02)

0.14 (−0.16; 0.43)

  P value

<0.0001

<0.0001

0.3583

Knee stiffness a

Week 18

   

 LSM (95% CI)

−1.73 (−1.87; −1.59)

−1.87 (−2.00; −1.73)

−0.14 (−0.33; 0.05)

  P value

<0.0001

<0.0001

0.1602

Week 26

   

 LSM (95% CI)

−1.80 (−1.93; −1.67)

−1.95 (−2.08; −1.82)

−0.15 (−0.33; 0.03)

  P value

<0.0001

<0.0001

0.1012

  1. Durolane from Q-med AB (Sweden) and Artz from Seikagaku Corporation (Japan). CI, confidence interval; LSM, ???. aA negative change from baseline is an improvement. bA positive change from baseline is an improvement.