| Methods |
Randomised
Controlled
Trial
Double‐blind
(masked observer)
Placebo‐ controlled
Parallel‐group
Multicentre (n=3 hospitals, 6 investigators)
Both ITT and
per protocol analyses. |
| Participants |
Country:
Taiwan
Mean age: 65
% Female: 76
Mean disease
duration: 427 days
Duration: 25 wk
Number randomised: 200
(HA 100,PL 100)
Inclusion:
>50 years of age,
diagnosed with
knee OA (ACR criteria: >50 y, crepitus, morning stiffness<30 min in duration)
pain >= 40/100 mm VAS on 50 foot walk
radiographic evidence Kellgren Lawrence II to III with predominance in TB compartment
acute disease or trauma leading to secondary OA must have occurred at least 5 y before study entry
Exclusion:
severe degeneration of knee joint with marked joint narrowing, varus, or valgus deformity of knee (>12o) or other joint deformities, or other joint disorders (e.g. inflammatory joint disease, specific arthropathy, severe axis deviations or instabilities, joint or skin infections, joint prostheses of the lower limbs or symptomatic hip)
ia steroid injections within the 2 wks prior to study entry
Baseline values:
Pain 50' walk
HA: 47.85
PL: 45.65
WOMAC Pain
HA: 45.73
PL: 45.39
WOMAC Function
HA: 46.54
PL: 45.45
WOMAC Stiffness
HA: 43.35
PL: 44.46 |
| Interventions |
Hyalgan
20 mg/2ml
5 weekly injections
Saline 2 ml
5 weekly
injections
Concurrent therapy: acetaminophen permitted as escape medica‐
tion up to max 3 g/day but not on the day before study visit
Not permitted:
oral & parenteral corticosteroids, ia corticosteroid injections, NSAIDs or analgesics other than acetaminophen, topical analgesic preparations, rehabiliation, physical therapy, acupuncture |
| Outcomes |
Pain during 50 foot walk (100 mm VAS)‐‐‐‐‐‐‐‐‐‐‐
WOMAC (VAS),
pt and iv overall effectiveness (1‐6:1=gravely worsened, 6=
excellent improvement),
acetaminophen
consumption,
50 ft walk time, volume of synovial effusion in study knee,
safety |
| Notes |
Jadad's: 2/5
R‐1,B‐1,W‐0
Fourth and fifth authors of abstract are affiliated with Fidia SpA, Italy.
One author of manuscript is affiliated with Fidia S.p.A.
Work supported by a grant from Medpharma. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
