| Methods |
Randomised
Controlled
Trial
Double‐blind
Multicentre (n=8)
Placebo‐ controlled
Stratified
Efficacy analysis: per protocol n=189, safety analysis: ITT, n=239 |
| Participants |
Country: Denmark, Finland, Norway,
Sweden
Mean age: 58
% Female:56
Mean disease duration:
Duration:20 wk
Number randomised:240
(HA 120, PL 120)
Inclusion:
40‐75 y
symptomatic, radiologically verified knee OA
(Ahlback stage 1 to 2)
knee pain on day of examination >10/100 mm VAS
Lequesne score >= 4 baseline
Exclusion:
significant symptoms of bilateral knee OA
previous IA fracture of knee
RA or other inflammatory arthritis
IA injection of steroids or other invasive procedure in knee in past 6 mth
any other condition that in‐
terferes with efficacy assessment or completion of trial
Baseline values:
pain
HA:44.4, PL: 42.3
activity level
HA:60.7, PL:60.7
knee function
HA:51.2, PL:49.3
ROM
HA:33.8, PL:38.5
Lequesne
HA:9.9, PL:9.6
Lysholm
HA:54.1, PL:57.9
Tegner
HA:2.7, PL: 2.6
Clincial exam
HA:20.8, PL:21.0 |
| Interventions |
Artzal (25 mg/2.5 ml) 5 weekly injections
Placebo:saline 2.5 ml 5 weekly injections
Local anaesthetic used.
Concurrent therapy:
analgesics & NSAID
permitted and monitored. |
| Outcomes |
Lequesne index
100 mm VAS for knee pain, ROM, activity level and total knee function‐‐‐‐‐‐‐‐‐‐‐‐‐
Tegner activity score, Lysholm knee function score
clinical exam
quantity of con‐
current medication
pt and examiner global (7 stages:
from much im‐
proved to much
worse)
volume of fluid aspirated
number of leuco‐
cytes in joint fluid |
| Notes |
Jadad's:4/5
R‐1,B‐2,W‐1
Effusion aspirated before injection
Stratification by age and Lequesne score
into 4 groups:
40‐60 y, Lequesne 4‐10;
40‐60 y,
Lequesne >10,
61‐75 y, Lequesne 4‐10,
61‐75 y, Lequesne >10
Standardisation meeting for injection tech‐
nique and assessment procedures.
Work supported by Medical Faculty of Lund University, the Swedish MRC, KaroBio AB and Astra Lakemedel AB. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
