| Methods |
Randomised
Controlled
Trial
Double‐blind
Blind observer
Parallel‐group
Placebo‐ and arthrocentesis‐ controlled
Single centre
ITT analysis
(5 inj HA versus PL) |
| Participants |
Country:
Italy
Mean age: 60
% Female:63
Mean disease
duration: NR
Duration:60 days
Phase 1, 6 mth Phase 2
Number randomised:100
(20/group)
Inclusion:
>= 40 y
ACR diagnosis of knee OA
clinical history of
painful knee OA for > 6 mth
+ knee effusion (> 3 ml)
pain on movement (> 40/100 mm VAS)
Exclusion:
generalised OA
secondary knee OA
known or suspected joint infection
poor general health status or specific condition that would interfere with functional assessments
arthrocentesis and/or IA injection within 3 mth
very severe knee OA (planned intra‐medicinal product)
Baseline values:
pain on movement
PL: 64.4, AR:64.5
HA1:61.7,HA3:
64.1,HA5: 63.3
Lequesne
PL:14.5,AR:14.3
HA1:14.0,HA3:
14.9, HA5:15.0
pain at rest
PL:45.6,AR:43.3
HA1:40.5, HA3:
44.7, HA5:43.6 |
| Interventions |
Hyalgan 20mg/2 ml 1 injection and arthrocentesis + 4 weekly arthrocentesis,
Hyalgan 20mg/2 ml and arthro‐
centesis + 2 HA weekly injections+
2 arthrocentesis,
Hyalgan 20mg/2
ml and arthro‐
centesis + 4 HA weekly injections,
Arthrocentesis=5 weekly arthrocentesis,
Placebo= Arthro‐
centesis and 2 ml
saline + 4 weekly saline injections
Concurrent therapy:
paracetamol permitted |
| Outcomes |
pain at rest by pt on 100 mm VAS
pain on movement by pt
on 100 mm VAS
Lequesne Index
‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
Range of motion by goniometer (flexion)
daily paracet‐
amol consumption
presence
joint effusion (volume)
global pt and observer assessment of treatment efficacy |
| Notes |
Jadad's:3/5
R‐1,B‐1,W‐1
Effusions
aspirated at Visit 1, but no aspira‐
tion at other visits except Day 35 (one wk after last injection) and 2 mth after beginning of study.
Dr. G.B. Guillou and Dr. E. Maheu assisted in preparing paper. J.M. Grouin (Fidia France) provided statistical analysis. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
