| 1 Pain (100 mm VAS) |
3 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 1.1 1 to 4 weeks post‐injection |
3 |
507 |
Mean Difference (IV, Fixed, 95% CI) |
0.56 [‐3.83, 4.94] |
| 1.2 5 to 13 weeks post‐injection |
3 |
507 |
Mean Difference (IV, Fixed, 95% CI) |
‐4.55 [‐9.09, ‐0.00] |
| 1.3 14 to 26 weeks post‐injection |
2 |
312 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.42 [‐6.90, 6.06] |
| 2 Pain score (0‐3) |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 2.1 1 to 4 weeks post ‐injection |
1 |
98 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.07 [‐0.28, 0.14] |
| 3 WOMAC pain (0‐20 Likert) |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 3.1 5 to 13 weeks post‐injection |
1 |
223 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.77 [‐1.61, 0.07] |
| 4 WOMAC function (0‐68 Likert) |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 4.1 5 to 13 weeks post‐injection |
1 |
223 |
Mean Difference (IV, Fixed, 95% CI) |
‐2.44 [‐5.33, 0.45] |
| 5 Lequesne Index (0‐24) |
3 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 5.1 1 to 4 weeks post‐injection |
1 |
195 |
Mean Difference (IV, Fixed, 95% CI) |
0.19 [‐0.85, 1.23] |
| 5.2 5 to 13 weeks post‐injection |
1 |
195 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.36 [‐1.40, 0.68] |
| 5.3 14 to 26 weeks post‐injection |
2 |
397 |
Mean Difference (IV, Fixed, 95% CI) |
0.51 [‐0.43, 1.45] |
| 6 Range of motion |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 7 Patient global assessment (number of patients improved) |
4 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 7.1 1 to 4 weeks post‐injection |
3 |
495 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.17 [1.04, 1.32] |
| 7.2 5 to 13 weeks post‐injection |
2 |
384 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.07 [0.95, 1.21] |
| 7.3 14 to 26 weeks post‐injection |
1 |
189 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.31 [1.00, 1.72] |
| 8 WOMAC stiffness (0‐8 Likert) |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 8.1 5 to 13 weeks post‐injection |
1 |
223 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.35 [‐0.73, 0.03] |
| 9 Number of survivors (patients not requiring additional treatment for study knee) 45 to 52 weeks post‐injection |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 10 Number of clinical failures |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 10.1 14 to 26 weeks post‐injection |
1 |
156 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.21 [0.04, 0.98] |
| 10.2 45 to 52 weeks post‐injection |
1 |
114 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.73 [0.49, 1.08] |
| 11 Safety: total withdrawals overall |
5 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 11.1 1 to 4 weeks post‐injection |
2 |
330 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.03 [0.48, 2.22] |
| 11.2 5 to 13 weeks post‐injection |
2 |
449 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.06 [0.64, 1.76] |
| 11.3 14 to 26 weeks post‐injection |
1 |
240 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.6 [0.15, 2.45] |
| 12 Safety: number of patients reporting adverse events (45 to 52 weeks post‐ injection) |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 13 Safety: withdrawals due to adverse events |
5 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 13.1 1 to 4 weeks post‐injection |
2 |
322 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.26 [0.03, 2.28] |
| 13.2 5 to 13 weeks post‐injection |
1 |
223 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.06 [0.07, 16.81] |
| 13.3 14 to 26 weeks post‐injection |
1 |
240 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.4 [0.08, 2.02] |
| 13.4 45 to 52 weeks post‐injection |
1 |
156 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.73 [0.11, 5.07] |
| 14 Safety: number of patients with local adverse reaction but study drug continued |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 15 Safety: number of adverse events probably/possibly related to treatment |
3 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 15.1 5 to 13 weeks post‐injection |
2 |
432 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.59 [1.12, 2.26] |
| 15.2 45 to 52 weeks post‐injection |
1 |
224 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.53 [0.08, 3.72] |
| 16 Safety: number of serious adverse events (45 to 52 weeks post‐injection) |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 17 Safety: total withdrawals overall (knees) |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 17.1 5 to 13 weeks post‐injection |
1 |
116 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.40 [0.16, 0.98] |
| 17.2 14 to 26 weeks post‐injection |
1 |
116 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.93 [0.65, 1.34] |
