| Methods |
Randomised
Controlled
Trial
Double‐blind
Masked‐observer
Placebo controlled
Parallel group
Multicentre (n=17)
Primary analysis population n=273
ITT for safety n=408 |
| Participants |
Country:
England
Mean age: 64
% Female: 68
Mean disease duration: 8 y
Duration: 1 y
Number randomised: 408
(HA 208, PL 200)
Inclusion:
primary OA of the knee by ACR criteria,
grade II or III Kellgren and Lawrence in medial tibiofemoral compartment
Exclusion:
OA of the hip or other joint disease severe enough to prevent assess‐
ment of knee,
psoriasis, sacro‐
ilitis, other joint disease, known or suspected joint infection, disease of skin overlying knee joint that prevented injections, other painful knee conditions or severe concurrent illnesses,
ia corticosteroid or radiocolloid treatment in 3 mths before study or ia or new/rearrange‐
ment surgical procedures on legs,
evidence of clinically important axial deviation of the legs (valgus or varus deformities),
history of allergic reactions to avian proteins, pregnant or breast‐feeding
Baseline values:
JSW
HA: 4.9
PL: 4.5
JSW>=4.6 mm
HA: 5.9
PL: 5.9
JSW<4.6 mm
HA: 3.5
PL: 3.4 |
| Interventions |
Hyalgan (20 mg/2 ml) 3 weekly injections
Placebo: saline
Course was repeated twice more at four‐monthly intervals.
Concurrent therapy: Free concomitant use of analgesics and NSAIDs, except indomethacin, was allowed but regimens had to be stable for at least one month before study entry. Concurrent treatment with corticosteroids, glucosamine or chondroitin sulphate was not permitted. |
| Outcomes |
Mean joint space width at 52 wk by computerised DIA‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
pain on walking (VAS),
knee pain (6 point categorical scale), Pt and investigator global impression of efficacy (5 point categorical scale), Lequesene Index, SF‐36 |
| Notes |
Jadad's:4/5
R‐1,B‐2,W‐1
If bilateral OA, more painful knee was treated.
Subgroups defined by joint space wideth >= or <4.6 mm at baseline.
The trial was supported by a grant from Fidia SpA, Abano Terme, Italy.
Second and third authors are affiliated with Sponsor. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
