| Methods |
Randomised
Controlled
Trial
Double‐blind
Multicentre (n=12)
2 wk washout
Both ITT n=256
and per protocol, n=233 with publication based on PP.
analyses done |
| Participants |
Country:
Germany
Mean age: 62
% Female: 61
Mean disease
duration: 4.4 y
Duration:6 mth
Number randomised:256
(FM 127, HA 129)
Inclusion:
radiologically confirmed knee OA (Ahlback 1 to 3) and ACR diagnostic criteria
investigator approval of with‐
drawal of analgesic medication
with escape medication being acetaminophen for study
Exclusion:
IA injections or arthroplasty to affected knee in last 3 mth
concomitant medical condi‐
tions that could interfere with study assessments such as hip OA
Baseline values:
pain
FM:56.2,HA:57.2
Lequesne
FM:11.2,HA:11.1 |
| Interventions |
Fermathron 2 ml
5 weekly injections
Hyalart 2 ml
5 weekly injections
Concurrent therapy:
Paracetamol,
Aspirin up to 150 mg
daily |
| Outcomes |
Lequesne ‐‐‐‐‐‐‐‐‐
use of escape medication by pt daily diary
VAS pain assess‐
ment of affected
knee
pt global (very good, good,
average, poor, very poor) |
| Notes |
Jadad's:5/5
R‐2,B‐2,W‐1
First author of publication is affiliated with Fermentech Medical Ltd. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
