| Methods |
Randomised
Controlled
Trial
2/3‐arms blinded
Hylan G‐F 20
group not blinded
Blinded assessor
Screen blinded patient
Parallel‐group
Multicentre
No washout
Efficacy analysis: Per protocol: n=93
Safety analysis:
ITT |
| Participants |
Country:
Canada
Mean age:61
% Female:65
Mean disease duration:6 y
Disease duration
statistically significantly
longer for NSAID only group
Duration:12 wk
Telephone follow‐up at 26 weeks
Number
randomised:102
(NSAID 34, HA 31, NSAID+HA 37)
Inclusion:
18‐75 y
chronic, idiopathic knee OA on radiographic examination
Kellgren and Lawrence Grade 1 to 3 in no more than 2 compartments and not 3 in patellofemoral
4 of 6: ESR<30mm/h, RF<1:160,
morning stiffness<=30 min, crepitus on active motion, tenderness of bony margins, MD absence of rheumatoid disease
tolerant of NSAID for at least 30 days
using joint actively on daily basis
score >50/100 on VAS for pain on motion with weight bearing
Exclusion:
serious systemic disease, depression or neuroses
acute synovitis
excessive effusion
clinically obese
varus/valgus of >15
pregnant or not using effective contraception
chronic daily steroid therapy
surgery or joint injection within previous 3 mths
Baseline values:
pain on motion
NSAID: 63
Hylan G‐F 20: 61
NSAID+Hylan G‐F 20: 60 |
| Interventions |
Usual
NSAID‐only + 3 weekly arthrocentesis
(NSAID‐only group)
Hylan G‐F 20
(2 ml) 3 weekly injections + arthrocentesis
(Hylan G‐F only group),
Usual NSAID+ Hylan G‐F20
(2 ml) 3 weekly injections + arthrocentesis
(Hylan G‐F 20 +
NSAID group)
Concurrent therapy:
acetaminophen usage for analgesia documented in weekly diaries (pill counts). |
| Outcomes |
Pain on motion with weight bearing (100 mm VAS)‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
Pain at rest, night, restriction of activity, pt's overall assessment of arthritic pain, pain during 50 foot walk, medial and lateral joint tenderness, evaluator's overall assessment of treatment : 100 mm VAS;
level of activity for each of standing, sitting, walking, climbing stairs (1=never able to perform,2=occa‐
sionally able to perform,3=fre‐
quently able to
perform); pt. pain severity (1=none,
2=only on starting activity after rest,3=during day when active,4=during day at rest,5=all day and waking pt at night); support used; level of activity for running; 50 foot walk time, evaluator scored effusion, medial and lateral joint tenderness, pain while walking, overall assessment, 50 foot walk time on 100 mm VAS
Assessments:
Wk 0,
1(baseline),
2,3,7,12,26 |
| Notes |
Jadad's:3/5
R‐2,B‐0,W‐1
13 pts had bilateral OA,
both treated but only most painful evaluated for efficacy while both evaluated for safety.
Arthrocentesis with removal of effusion if present before treatment.
15% subjects presented wtih an effusion.
Incomplete blinding of hylan G‐F 20 only group with instruction to discontinue NSAID therapy may have introduced bias.
Work supported by Biomatrix, Inc. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
