| Methods |
Randomised
Controlled
Trial
Double‐blind
Blind observer
Screen blinded patient
Parallel‐group
Multicentre
(n=18)
3‐7 day washout
Efficacy analysis:
both ITT n=165 and per protocol n=134
Safety analysis:
ITT |
| Participants |
Country:
England and
Scotland
Mean age:63
% Female:53
Mean disease
duration:NR
Duration:12 wk
Number randomised:165
(HA ‐ 53, DI ‐ 55, CN ‐ 57)
Inclusion:
35‐80 y
radiologically
confirmed knee OA (tibofemoral compartment) and no other OA joint likely to warrant escape analgesia
knee had to be most painful joint
xray report <2 y
end of washout 2/5 WOMAC pain >40/100 mm VAS
Exclusion:
bed ridden pts
pts in wheelchair
or unable to walk 50 steps unaided
other jt disease
clinically significant renal, hepatic or haematological disorders
any contraindication to study treatments
Baseline values:
WOMAC pain
HA:59, DI:61, CN:58
WOMAC function
HA: 54, DI: 56,
CN: 56
Lequesne
HA: 13.9, DI: 13.9
CN: 14.5 |
| Interventions |
Hylan G‐F 20 (2 ml) 3 weekly injections+arthro‐
centesis + placebo capsules od
Diclofenac retard
100 mg od + arthrocentesis
Control: Arthro‐
centesis + placebo capsules od
Concurrent therapy:
paracetamol 3000 mg daily permitted |
| Outcomes |
WOMAC pain subscale‐‐‐‐‐‐‐‐‐‐‐
WOMAC stiffness
and function
Lequesne Index
pt. and blinded observer overall opinion of treatment (5‐pt verbal scale:very
poor, poor, fair,
good,very good)
Assessments:
Wk 0,1,2,4,8,12 |
| Notes |
Jadad's:4/5
R‐1,B‐2,W‐1
17 bilateral
injections
target knee
Arthrocentesis removing all joint
fluid in all 3 groups.
At end of 12 DBRCT, patients could enter an open label one‐year extension study in which they could receive up to four repeat courses of Hylan G‐F 20.
Syntex Pharma‐
ceuticals Ltd. and Roche Products Ltd provided financial support. Biomatrix, Inc. supplied hylan G‐F 20 and Dr. Arnold Goldman provided statistical analysis. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
