Methods |
Randomised
Controlled
Trial
Parallel group
Singel centre |
Participants |
Country: Turkey
Mean age: 61.5
% Female: 70
Mean disease duration: NR
Duration: 3 wk
Number randomised: 40
(Orthovisc 20, Hylan G‐F 20 20)
Inclusion:
fulfill ACR criteria for knee OA,
Kellgren‐Lawrence grade II or III
Exclusion:
use of analgesic or NSAID,
pts with concomitant rheumatological disease, active synovitis, surgical or arthroscopic interventions or ia steroid or HA treatment during the past 6 mth
Baseline values:
WOMAC pain:
OR: 11.2
GF: 10.8
WOMAC stiffness
OR: 3.8
GF: 3.6
WOMAC function
OR: 35
GF: 31.9
ICAM‐1
OR: 19.2
GF: 17.8
VCAM‐1
OR: 40.5
GF: 37.8 |
Interventions |
Orthovisc
2 ml, 30 mg
(Anika Therapeutics)
3 weekly injections;
Hylan G‐F 20
Synvisc
2 ml, 16 mg
(Wyeth)
3 weekly injections
Concurrent therapy: None permitted as per exclusion criteria |
Outcomes |
WOMAC OA Index
pain (0‐20),
stiffness (0‐8),
physical function (0‐68)
biochemical measurements:
sICAM‐1 and sVCAM‐1 in SF samples |
Notes |
Jadad's: 1/5
R‐1, B‐0, W‐0
No baseline differences between groups of demographic features, clinical indices or lab values. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |