| Methods |
Randomised
Controlled
Trial
Blind observer
Parallel‐group
Placebo‐ controlled
Single centre,
Principal efficacy criteria: ITT
all other efficacy: per protocol n=81 |
| Participants |
Country:
England
Mean age: 65
% Female: 67
Mean disease duration: NR
Duration:6 mth
Number randomised:100
(HA 50, PL 50)
Inclusion:
fully ambulant
mono or bilateral knee OA
Grade 2 to 3 Kellgren and Lawrence within 6 mth prior
consistent pain for 3 mth prior
moderate or severe pain on walking at screen and baseline visits
Exclusion:
Grade 4 Kellgren and Lawrence
serious functional impair‐
ment at knee
associated OA of hip that interferes with knee assessment
OA of any other jt that affect knee assessment
psoriasis
radiographic evidence of sacroilitis or any other joint disease other than OA
known or suspected jt infection
poor general health or other conditions preventing hospital attendance
skin conditions overlying jt affecting injection
painful knee conditons other than OA
severe hepatic or renal disease or major medical
conditions
use of IA steroid or radiocolloid within 3 mth
Baseline values:
pain on walking
HA:65.8, PL:61.9
Lequesne
HA:13.4, PL:14.0 |
| Interventions |
Hyalgan (20mg/2 ml) 5 weekly injections
Placebo: saline
2 ml 5 weekly injections
Concurrent therapy:
Existing analgesic & NSAID continued as considered appro‐
priate by referring physician |
| Outcomes |
pain on walking (100 mm VAS)
Lequesne ‐‐‐‐‐‐‐‐‐
knee pain at rest (100 mm VAS)
joint tenderness,
swelling (4 point:
none,mild,mod‐
erate, severe)
am stiffness, in‐
activity stiffness
(min), pt. global impression (excellent, fair,
poor, useless)
satisfaction index |
| Notes |
Jadad's:4/5
R‐1,B‐2,W‐1
Effusions aspirated |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
