Scale 1994b (3 inj).
Methods | See Scale 1994a above. | |
Participants | Country: Germany Mean age: 59 % Female: Study B: 44 (24/55) Mean disease duration: 4.2 y Duration: 12 wk Telephone follow‐up at 26 wk Number randomised: 30 (HA 15, Pl 15) Inclusion/ Exclusion as above (Scale 1994a). Baseline group differences: 1) Significantly more patients had Grade 4 xray in PL group. 2) 3 inj group had significantly shorter disease duration at baseline. | |
Interventions | Hylan G‐F 20 (2 ml) 3 weekly injections Placebo: Phosphate‐ buffered saline 2.0 ml Concurrent therapy: No medication to treat arthritis pain allowed. | |
Outcomes | See Scale 1994a above. Assessments: Wk 0,1,2,3,8,12, 26 | |
Notes | Jadad's:4/5
R‐1,B‐2,W‐1
See Scale 1994a above. Excluded pts with effusions. Arthrocentesis with removal of effusion if present. If bilateral OA only most painful knee treated. Research was supported by Biomatrix, Inc. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | A ‐ Adequate |