Table 5.
Mean reduction on WOMAC A (Pain), B (Stiffness), and C (Function) scores (mm)*
| 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 |
*For the intent-to-treat population in the Synvisc-One, Hydros, and Hydros TA groups, observed at landmark time points.
Abbreviations: WOMAC = Western Ontario and McMaster Universities Osteoarthritis Index; LSMeans = Least Squares Means; SE = Standard Error.