| Methods |
Randomised
Controlled
Trial
Single‐blind
Blinded assessor for
arthroscopic assessment.
Parallel‐group
Single centre |
| Participants |
Country:
Italy
Mean age: 50
% Female: 53
Mean disease
duration: 25 mth
Duration: 6 mth
Number randomised: 99
(HA 52, MP 47)
Inclusion:
Outpatient re‐
ferred to Rheumatology
Unit for OA over a 3 yr period
Primary OA or OA secondary to traumatic events to the knee.
Kellgren and
Lawrence Grades I to III
Fulfill clinical and radiological criteria of ACR
Exclusion:
Pt judged not
controllable or
unreliable.
Presence of severe concom‐
itant diseases,
suspected joint infection.
Concomitant treatment with NSAID
IA steroid treatment in previous 3 mth
Pregnancy and breast feeding
Baseline:
Pain after spontaneous movement:
HA: NR
MP: NR
Pain after forced movement
HA: NR
MP: NR |
| Interventions |
Hyalgan
(20 mg/2ml)
5 weekly injections
Methylpredniso‐
lone acetate
3 weekly injections |
| Outcomes |
Noctural pain,
pain at rest,
pain on spontan‐
eous or forced
movement,
pain on touch (all on 100 mm VAS)
morning stiffness (min),
joint motion
(max active flexion/extension)
pt and MD opinion of efficacy (0=poor (unsatisfactory),
1=scarce,2=fair,
3=good,4=excel‐
lent)
use of analgesic
or NSAID
cartilage damage (modified version of the Outer‐
bridge & Noyes scales): degree of cartilage damage (5 point scale) and extent of cartilage lesions
(6 point scale) |
| Notes |
Jadad's:4/5
R‐2,B‐1,W‐1
When OA was bilateral, most severely affected knee selected for treatment. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
