| Methods |
Randomised
Controlled
Trial
Double‐blind
Screen blinded patient
Blinded assessor
Multicentre (n=4)
2 wk washout
of NSAID and analgesics.
ITT analysis |
| Participants |
Country:
Germany
Mean age: 62
% Female: 65
Mean disease duration: 6 y
Duration: 12 wk
Telephone follow‐up
at 26 wk
Number randomised: 110
(HA 52, PL 54,
HA+PL 4)
[117 knees:
HA 57, PL 60]
Inclusion:
> 18 y
male & female
chronic primary OA of knee of Larsen Grade 1‐3
ESR < 40 mm/h
RF < 1:160
daily pain on activity and persistent pain despite use of NSAIDs or analgesics
Exclusion:
pts with effusion in knee
Baseline values:
pt wtbearing pain
HA:71, PL:75
pt night pain
HA:42, PL:47
MD wtbearing
pain
HA:71, PL:75
MD night pain
HA:41, PL:47
MD loss of
activity
HA:59, PL:67 |
| Interventions |
Hylan G‐F 20
(2 ml)
3 weekly injections
Placebo: phosphate‐
buffered saline
2 ml
3 weekly injections
Concurrent therapy:
Standard care per‐
mitted: steroids,
NSAIDs, analgesics,
PT, surgery |
| Outcomes |
pt: pain wt bearing, at rest during night, decrease during most painful movement, treatment success
MD: extent of pt's loss of activity while performing difficult daily tasks & treatment success
all above on 100 mm VAS
Assessments:
Wk 0,1,2,3,8,12,
26 |
| Notes |
Jadad's:4/5
R‐1,B‐2,W‐1
Local analgesia was optional.
If bilateral OA, only most painful knee treated.
7 pts bilateral ‐ 14 knees: 6 HA , 8 PL. Each knee randomised and analysed independently for efficacy but for safety these pts. were considered individuals. Time between treatment of two knees varied from 0 to 153 days.
Pts with effusions excluded.
Arthrocentesis with removal of effusion if present. At baseline, Larsen xray grade III to IV:
HA: 28% versus PL:57%(p<0.05),
duration of OA <1 y: HA: 28% versus PL: 10% (p<0.025)
Work was supported by Biomatrix, Inc. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
