| Methods |
Randomised
Controlled
Trial
Double‐blind
Blinded assessor
Multicentre (n=6)
2 wk washout
of NSAIDs and analgesics.
Efficacy analysis:
both ITT and per protocol.
Tolerability analysis: ITT |
| Participants |
Country:
Germany
Mean age: 60
% Female: 51
Mean disease duration: 4.6 y
Duration: 12 wk
Number randomised:
132 pts (148 knees) in 4 arms of trial.
In 2 arms GF/AR:
70 patients
(GF 38, AR 32)
[73 knees:
GF 38, AR 35]
[Healon 39 knees, NE hylan 36 knees]
Inclusion:
> 18 y
primary OA knee (Larsen 1 to 3)
ESR < 40 mm/h
RF < 1:160
daily, persistent pain despite use of pain relieving
medications
Exclusion:
free of pain in OA knee
detectable effusion in joint at time of first treatment
considered unreliable by the
investigator
Baseline values:
pt wtbearing pain
HA:70, AR:72
MD wtbearing pain
HA:69, PL:72 |
| Interventions |
Hylan G‐F 20
(2 ml)
3 weekly injections,
Artz
(2 ml)
3 weekly injections,
Healon
3 weekly injections,
Nonelastoviscous denatured hylan fluid
3 weekly injections
Subcutaneous local anesthetic optional in both groups.
Concurrent therapy:
Standard care per‐
mitted |
| Outcomes |
wt bearing pain by pt and MD on 100 mm VAS
overall treatment response by pt & MD(100mmVAS)
improvement on most painful knee movement by pt 100 mm VAS
Assessments:
Wk 0,1,2,3,8,12 |
| Notes |
Jadad's:4/5
R‐1,B‐2,W‐1
Pt with detectable effusion excluded
Arthocentesis with removal of effusion if present.
If bilateral OA both knees could be treated and evaluated. 16 patients had bilateral OA. Each knee randomised and independently evaluated for efficacy. Time between treatment of two knees varied from 0 to 23 days but 11/16 had the same day.
4‐arm study but only 2 arms reported in publication (Hylan G‐F 20 and Artz). Biomatrix, Inc. provided support for this work and performed all elastoviscosity analyses. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
