| Methods |
Randomised
Controlled
Trial
Single‐blind
Parallel‐group
Multicentre
Placebo‐ controlled
Efficacy analysis:
per protocol n=95, ITT done to check consistency of
per protocol |
| Participants |
Country:
France
Mean age: 68
% Female:71
Mean disease duration:
Duration: 1 y
Number randomised:110
(HA 55, PL 55)
Inclusion:
ACR criteria for
knee OA
Femorotibial localisation of disease
+ knee effusion
painful knee (>= 40/100 mm VAS)
stable dose of OA therapy for 3 mth
NSAID, analgesics, physiotherapy stable for one mth
Exclusion:
serious concomitant illness
secondary OA of knees by ACR
knee with prothesis
any IA surgery of evaluated knee,
menisectomy in 10 y prior
any extra‐articular surgery of evaluated knee,
osteotomy last 2 y
arthrocentesis of evaluated knee in previous 3 mth
Baseline values:
Lequesne
HA:11.6, PL:10.9
Pain at rest
HA:31.4, PL:28.0
Pain after exercise
HA:67.6, PL:61.9 |
| Interventions |
Hyalgan (20 mg/2ml) 4 weekly injections
Placebo:saline vehicle (2 ml) 4 weekly injections
Concurrent therapy:
previous treatment continued at same dose schedule; between Wks 7‐52, corticosteroid injection, SF aspira‐
tion, total knee re‐
placement allowed |
| Outcomes |
degree of inflam‐
mation by presence and amount of synovial fluid effusion by
arthrocentesis‐‐‐‐
pain at rest and after exercise on 100 mm VAS
Lequesne Index
overall pt and MD assessment
requirement for local therapies between Wk 7 & Wk 52 (number and time) |
| Notes |
Jadad's:2/5
R‐1,B‐0,W‐1
The MD who did injection was also the assessor and therefore may not have remained blind.
Dr. G.B. Buillou and J.M. Grouin (Fidia, France) provided statistical analysis. Helpful assistance from: V. Figeac, C. Strauss, C. Kubiak, and N. Chevalier. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
