| Methods |
Randomised
Controlled
Trial
Single‐blind
Parallel‐group
Single centre
3 mth washout of IA treatments
Per protocol
analysis, n=52 |
| Participants |
Country:
Italy
Mean age:57
% Female:75
Mean disease
duration:44%
1‐5 y
Duration:60 days
Number randomised:55
[57 joints:HA40 20, HA20 19, PL 18]
Inclusion:
knee OA on basis of clinical & radiological
(Kellgren Grade 2 to 4)
findings
Exclusion:
NR |
| Interventions |
Hyalgan 40 mg
3 weekly injections
Hyalgan 20 mg
3 weekly injections
Placebo = saline 2 ml 3 weekly injections
Concurrent therapy:
Not reported |
| Outcomes |
Spontaneous pain on 10 cm VAS, walking and under load pain on 1‐5 scale
(1=none, 5=severe), pt. and MD global assessment on 1‐5 scale (1=very poor, 5=very good) |
| Notes |
Jadad's:2/5
R‐1,B‐0,W‐1
5 pt had bilateral OA ‐ knees treated at different times.
A. Perbellini (Fidia S.p.A.)
C. Baggio and E. Palin provided statistical analysis. A. Babolin provided secretarial assistance. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
