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Table 5 Mean reduction on WOMAC A (Pain), B (Stiffness), and C (Function) scores (mm)*

From: Safety and performance of Hydros and Hydros-TA for knee osteoarthritis: a prospective, multicenter, randomized, double-blind feasibility trial

  

Between Group Differences

 

Mean reduction (Pain) from Baseline [LSMeans(SE)]

Synvisc-One – Hydros

Synvis-One – Hydros-TA

Time Points

Synvisc-One n=32

Hydros n=32

Hydros-TA n=34

LSMeans

p-value

LSMeans

p-value

Baseline

66.4

68.1

69.4

N/A

N/A

N/A

N/A

2 weeks

-28.5 (5.9)

-23.3 (5.6)

-35.6 (5.2)

5.2

0.40

-7.1

0.25

6 weeks

-25.6 (5.9)

-32.4 (5.6)

-33.4 (5.2)

-6.8

0.28

-7.8

0.21

13 weeks

-29.0 (6.0)

-33.9 (5.6)

-33.3 (5.2)

-4.9

0.43

-4.3

0.49

26 weeks

-28.9 (6.0)

-32.4 (5.6)

-35.2 (5.3)

-3.5

0.58

-6.3

0.33

Overall

-28.0 (5.4)

-30.5 (5.1)

-34.4 (4.7)

-2.5

0.64

-6.4

0.24

  

Between Group Differences

 

Mean reduction (Stiffness) from Baseline [LSMeans(SE)]

Synvisc-One – Hydros

Synvis-One – Hydros-TA

Time Points

Synvisc-One n=32

Hydros n=32

Hydros-TA n=34

LSMeans

p -value

LSMeans

p -value

Baseline

70.1

70.5

70.3

N/A

N/A

N/A

N/A

2 weeks

-25.9 (6.7)

-18.4 (6.4)

-33.7 (6.0)

7.5

0.29

-7.8

0.27

6 weeks

-24.0 (6.7)

-24.2 (6.4)

-31.4 (6.0)

-0.2

0.98

-7.4

0.30

13 weeks

-25.9 (6.8)

-26.4 (6.4)

-27.4 (6.0)

-0.5

0.94

-1.5

0.83

26 weeks

-24.6 (6.9)

-29.0 (6.5)

-26.8 (6.0)

-4.4

0.55

-2.2

0.77

Overall

-25.1 (6.1)

-24.5 (5.8)

-29.8 (5.3)

0.6

0.92

-4.7

0.43

  

Between Group Differences

 

Mean reduction (Function) from Baseline [LSMeans(SE)]

Synvisc-One – Hydros

Synvis-One – Hydros-TA

Time Points

Synvisc-One n=32

Hydros n=32

Hydros-TA n=34

LSMeans

p -value

LSMeans

p -value

Baseline

63.5

66.2

65.1

N/A

N/A

N/A

N/A

2 weeks

-23.7 (6.0)

-20.2 (5.8)

-32.1 (5.3)

3.5

0.58

-8.4

0.18

6 weeks

-23.5 (6.0)

-29.2 (5.8)

-29.0 (5.3)

-5.7

0.37

-5.5

0.38

13 weeks

-25.6 (6.1)

-31.0 (5.8)

-29.1 (5.3)

-5.4

0.39

-3.5

0.58

26 weeks

-24.5 (6.1)

-29.0 (5.8)

-29.5 (5.4)

-4.5

0.49

-5.0

0.44

Overall

-24.3 (5.6)

-27.3 (5.4)

-30.0 (4.9)

-3.0

0.59

-5.6

0.31

  1. *For the intent-to-treat population in the Synvisc-One, Hydros, and Hydros TA groups, observed at landmark time points.
  2. Abbreviations: WOMAC = Western Ontario and McMaster Universities Osteoarthritis Index; LSMeans = Least Squares Means; SE = Standard Error.