| Methods |
Randomised
Controlled
Trial
Double‐blind
Parallel‐group
Multicentre (n=3)
Placebo‐ controlled
Per protocol analysis |
| Participants |
Country:
England
Mean age: 69
% Female: 54
Mean disease
duration: NR
Duration: 48 wk
Number randomised: 63
(HA 30, PL 33)
Inclusion:
outpatients of either sex and any age
symptomatic OA of one of both knees
informed consent
Exclusion:
inflammatory knee conditions,
e.g. RA, psoriatic, pseudo‐
gout or joint infection
OA of the hip which could confuse assessment
poor general health
skin conditions which would deter injection
receiving regular analgesic therapy for reasons other than painful OA of the knee |
| Interventions |
Hyalgan (20 mg/2 ml)
up to 11 injections over a 23 week period
Placebo: l/100th of active, e.g. 0.2 mg sodium hyaluronate
Concurrent therapy:
Paracetamol 3000 mg daily permitted |
| Outcomes |
pain at rest and on movement (100 mm VAS)
activities of daily living (6 activities
scored 0=no diff‐
iculty to 7=activity
impossible, total = 42)
questioned and ex‐
amined for local or systemic adverse reactions |
| Notes |
Jadad's:4/5
R‐1,B‐2,W‐1
Dr. M. Massarotti, Dr. D. Massari and Dr. U. Cornelli of Fidia S.p.A. supported study and supplied clinical trial material. Dr. R. Kohn and Dr. J.F. Harper of Advisory Services, London helped with trial organisation. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
