| Methods |
Randomised
Controlled
Trial
Steering Committee blinded
Multicentre (n=14)
Parallel‐group
Open‐label
ITT analysis |
| Participants |
Country:
Canada
Mean age: 63
% Female: 70
Mean disease duration: 9.5 y
Duration: 1 y
Number randomised: 255
(AC+H 127, AC 128)
Inclusion:
>40 y
primary diagnosis of radiologically verified OA in study knee
symptomatic (>175/500 WOMAC pain) despite prior treatment with NSAIDs or acetaminophen
ambulatory
willing to participate
sign informed consent
Exclusion:
Grade 4 (Kellgren)
contraindicated per Hylan G‐F20 label
inflammatory arthropathies
tense effusion in study knee at baseline
chondrocalcinosis
varus or valgus deformity >12o in study knee
steroid inj in prior 3 mths in study knee
prior viscosupplementation
isolated patello‐femoral OA
uncontrolled morbidity particularly that in any joint which would impede measurements in study knee
Baseline values:
WOMAC pain
AC+H: 11.35
AC: 11.94
WOMAC function
AC+H: 39.54
AC: 40.20 |
| Interventions |
Appropriate care with hylan G‐F20
(AC+H)
Appropriate care without hylan G‐F20
(AC)
Concurrent therapy:
Standard care |
| Outcomes |
Mean change in WOMAC LK3.0 pain score in study knee baseline to termination‐‐‐‐‐‐‐‐
% pts improved at termination from baseline for 1) 20% improve‐
ment WOMAC pain in study knee, 2) 20% WOMAC pain and either 20% ftn or stiffness in study knee
pt global assessment of effectiveness for 1) OA in study knee, 2) OA in all jts, 3) overall health
HRQOL: WOMAC, SF‐36, HUI3
safety: pt. self report during telephone inter‐
view and global assessments of side effects
Assessments:
Wk0,Mth1,2,4,6,8,19,12 (Wk 0 and
Mth 12 at site; others by telephone interview) |
| Notes |
Jadad's: 3/5
R‐2,B‐0,W‐1
109 AC+H and 108 AC had bilateral knee OA.
Tense effusion at baseline excluded pt.
Although Grade IV xray grade was to be excluded, 20% of AC+H and 33% of AC had grade IV.
An independent Steering Committee designed the study, developed analysis plan, resolved methodological issues and interpreted and disseminated results.
A CRO, Innovus Research Inc., managed the study.
Study was funded by Biomatrix, Inc.and Rhone‐Poulenc Rorer Canada Inc. Dan Pericak provided statistical analysis. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
