| Methods |
Randomised
Controlled
Trial
Parallel‐group
Double blind
Masked observer
Adverse events monitor
Placebo‐controlled
Multicentre (n=10)
2 wk washout
Per protocol analysis, n=181
Post‐hoc retrospective subgroup effectiveness population, n=135 (OR 66, PL 69)
ITT (safety) |
| Participants |
Country:
United States
Mean age: 66
% Female: 63
Mean disease duration: NR
Duration: 27 wk
Number randomised: 226
(OR 114, PL 112)
Inclusion:
idiopathic knee OA
Kellgren and Lawrence Grade 2 or 3
significant pain (WOMAC pain >= 13/20) in index knee
WOMAC pain <13/20 in contra‐
lateral knee
able to walk 50 ft unassisted
discontinue anal‐
gesics (2 wk) and NSAIDS for 5 half‐lives
not pregnant or planning a pregnancy
Exclusion:
contralateral knee WOMAC pain score >= 13/20
contralateral knee Kellgren and Lawrence < Grade 4 in either knee
initiation of quads exercise within 4 mths
oral or IM steroid use within 2 mth
IA injection of HA within 21 y
allergy to lidocaine
clinically signifi‐
cant comorbidity (renal/hepatic) or abnormal lab tests
treatment with anticoagulants, immunosuppressives or muscle
relaxants
inability to tolerate aceta‐
minophen
Baseline values:
WOMAC pain
OR:16.4, PL:16.3
WOMAC stiffness
OR: 7.0, PL: 6.8
WOMAC function
OR: 54.8,PL:54.5 |
| Interventions |
Orthovisc 15 mg/ml
2 ml once per week
3 weekly injections
plus 1% lidocaine HCI 3‐5 ml
Placebo: Saline 2 ml 3 weekly injections
plus 1% lidocaine HCI 3‐5 ml
Concurrent therapy:
acetaminophen max
of 4 g/day; however not 24 hr before visit |
| Outcomes |
WOMAC pain (5‐25)
pain on standing
pt and investigator global assessment
WOMAC stiffness (2‐10) and function (17‐85)
pain after a 50 foot walk (1=none,2=mild,3=moderate,4=severe,5=extreme)
time to walk 50'
vital signs, labs, MedDRA adverse events |
| Notes |
Jadad's: 4/5
R‐1,B‐2,W‐1
Treated index knee exclusively
Bilateral OA in 89 OR and 99 PL pts.
Effectiveness population: completed minimum of 15 wks, no major protocol violations, WOMAC pain score for contra‐
lateral knee <12
Severity of contra lateral knee pain confounded out‐
come measure‐
ment in the index knee.
Supported in part by a grant from Anika Thera‐
peutics, Inc. Data management and statistical analyses by Boston Bio‐
statistics, Inc. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
