| 1 Responder: reduction in the WOMAC pain score of at least 40% with an absolute improvement of at least 5 points |
2 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 1.1 Week 2 |
1 |
346 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.80 [0.59, 1.09] |
| 1.2 Week 6 |
1 |
346 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.23 [0.91, 1.66] |
| 1.3 Week 13 |
1 |
346 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.91 [0.68, 1.23] |
| 1.4 Week 26 |
1 |
346 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.90 [0.66, 1.24] |
| 2 Responder: patients only with knee OA, reduction in WOMAC pain score of at least 40%, abs improvement 5 points |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 2.1 Week 2 |
1 |
216 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.97 [0.67, 1.40] |
| 2.2 Week 6 |
1 |
216 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.53 [1.05, 2.23] |
| 2.3 Week 13 |
1 |
216 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.08 [0.74, 1.56] |
| 2.4 Week 26 |
1 |
216 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.96 [0.65, 1.42] |
| 3 WOMAC pain (change from baseline; 0 to 20 Likert) |
2 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 3.1 Week 2 |
1 |
346 |
Mean Difference (IV, Fixed, 95% CI) |
0.74 [0.02, 1.46] |
| 3.2 Week 6 |
1 |
346 |
Mean Difference (IV, Fixed, 95% CI) |
0.24 [‐0.57, 1.05] |
| 3.3 Week 13 |
1 |
346 |
Mean Difference (IV, Fixed, 95% CI) |
0.55 [‐0.30, 1.40] |
| 3.4 Week 26 |
1 |
346 |
Mean Difference (IV, Fixed, 95% CI) |
0.39 [‐0.47, 1.25] |
| 4 WOMAC stiffness (change from baseline; 0 to 8 Likert) |
2 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 4.1 Week 2 |
1 |
346 |
Mean Difference (IV, Fixed, 95% CI) |
0.51 [0.16, 0.86] |
| 4.2 Week 6 |
1 |
346 |
Mean Difference (IV, Fixed, 95% CI) |
0.16 [‐0.20, 0.52] |
| 4.3 Week 13 |
1 |
346 |
Mean Difference (IV, Fixed, 95% CI) |
0.34 [‐0.06, 0.74] |
| 4.4 Week 26 |
1 |
346 |
Mean Difference (IV, Fixed, 95% CI) |
0.35 [‐0.04, 0.74] |
| 5 WOMAC physical function (change from baseline; 0 to 68 Likert) |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 5.1 Week 2 |
1 |
346 |
Mean Difference (IV, Fixed, 95% CI) |
2.15 [‐0.14, 4.44] |
| 5.2 Week 6 |
1 |
346 |
Mean Difference (IV, Fixed, 95% CI) |
1.0 [‐1.58, 3.58] |
| 5.3 Week 13 |
1 |
346 |
Mean Difference (IV, Fixed, 95% CI) |
1.74 [‐0.97, 4.45] |
| 5.4 Week 26 |
1 |
346 |
Mean Difference (IV, Fixed, 95% CI) |
1.60 [‐1.11, 4.31] |
| 6 Safety: total withdrawals overall |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 7 Safety: withdrawals due to inefficacy |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 8 Safety: withdrawals due to adverse events |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 9 Safety: number of patients affected by device‐related adverse events |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 10 Safety: number of patients with adverse events related to injection only |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 11 Safety: number of patients with non‐serious treatment‐related adverse events |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 12 Safety: number of patients with non‐serious adverse events |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 13 Safety: number of patients with treated unrelated adverse events |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 14 Safety: number of patients with serious treatment‐unrelated adverse events |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
