| Methods |
Randomised
Controlled
Trial
Single‐blind
Parallel‐group
Washout
Mth 2: ITT analysis,
Mth 12: Per protocol |
| Participants |
Country:
Italy
Mean age: 64
% Female:81
Disease
duration: NR
Duration:1 y
Number randomised:36
(HA 20, MPA 16)
[40 jts: HA 20, MPA 20]
Inclusion:
active gonarthrosis
Kellgren Grade 2 or 3
Exclusion:
no other joint disease
Baseline values:
spontaneous pain
HA:41.3,
MPA: 33.4
passive movement
HA:115.8
MPA:109.0
active movement
HA:108.4
MPA:104.2
ring size
HA: 43.0,
MPA: 42.6
# jts.pain under load
HA:18, MPA:19
# jts walking pain
HA:20, MPA:20 |
| Interventions |
Hyalgan (20 mg/2ml) 3 weekly injections
Methylpredniso‐
lone acetate (MPA) 40 mg/1 ml
(Depo‐Medrol)
3 weekly injections
Concurrent therapy:
simple analgesics permitted for most severe pain, no NSAIDs for first 2 mths then allowed for short periods (<2 wk) between end of mth 2 and mth 12 |
| Outcomes |
spontaneous pain on VAS
pain under load and on walking (1=absent to 5=
very severe)
active and passive movement in degrees
ring size in cm |
| Notes |
Jadad's:2/5
R‐1,B‐0,W‐1
4 pts had bilateral OA; each knee counted as 'one' case.
R. Bruno and A. Perbellini, Fidia SpA. C. Baggio and C. Zanetti 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 |
