| Methods |
Randomised
Controlled
Trial
Double‐blind
Parallel‐group
Multicentre (n=24)
Efficacy analysis: per protocol, n=195, safety analysis: ITT, n=209 |
| Participants |
Country:
Germany
Mean age: 62
% Female: 64
Mean disease
duration: NR
Duration:18 wk
(Wk 18 either in person or
telephone follow‐up)
Number randomised:209
(HA 102, PL 107)
Inclusion:
40‐75 y
informed consent
idiopathic OA of knee defined by clinical and xray criteria (Lequesne)
Exclusion:
inflammatory jt disease
ESR>40 mm
RF >1:40
specific arthropathies (chondrocalcinosis, jt effusion >100 ml)
excessive obesity
severe axis deviations or instabilities
protheses of lower limbs
symptomatic hip
IA injection in prior 3 mth
infectious or febrile diseases
joint or skin infections pregnancy
contraindication to paracetamol
Baseline values:
pain
HA:54.1, PL:51.4
Lequesne
HA:10.4, PL:9.4
pain under load
(% pt moderate/ severe)
HA:90.5, PL:87.0
pain at rest
(% pt moderate/
severe)
HA:41.1, PL:35.0
pain starting to walk (% pt mod‐
erate/severe)
HA: 73.3, PL:63.0 |
| Interventions |
Artz (25mg/2.5 ml)
5 weekly injections
Placebo:sodium hyaluronate 0.25mg/2.5 ml
5 weekly injections
Concurrent therapy:
Paracetamol up to 1‐2 tabs of 500 mg tid daily permitted |
| Outcomes |
Lequesne
paracetamol consumption‐‐‐‐‐
modified Lequesne
pain last week,at rest, under load, starting (100 mm VAS)
crepitation
joint effusion
joint mobility
pt and MD global
efficacy rating
overall tolerance |
| Notes |
Jadad's:5/5
R‐2,B‐2,W‐1
Significantly more females in Artz group (73% versus 55%, P value 0.011)
Retrospective analysis indicated patients >60 y and Lequesne >10 most likely to benefit from treatment.
Work sponsored by Luitpold Pharma Munich. Statistical evaluations performed by Mr. Elsasser. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
