| Methods |
Randomised
Controlled
Trial
Double blind
Parallel group
Single centre
Placebo and active controlled
Blinded evaluator |
| Participants |
Country: Turkey
Mean age: 59.5
% Female: 88
Mean disease duration: 4 y
Duration: 6 mth
Number randomdised:
(Orthovisc 26,
Synvisc 26,
Saline 26)
Inclusion:
patients with knee OA according to ACR criteria,
Kellgren‐ Lawrence grades II‐IV
Exclusion:
renal and hepatic comorbidity,
abnormal lab tests,
treatment with anticoagulants or immunosuppressives, intra‐articular injection of HA or steroids within the past 12 mth,
any quadriceps exercise programe within the last 4 mth
Baseline values:
WOMAC pain
OR: 16.5
SYN: 18
PL: 20
WOMAC stiffness
OR: 6.5
SYN: 7
PL: 6
WOMAC function
OR: 52.5
SYN: 55
PL: 59.5
Patient global
OR: 90
SYN: 80
PL: 90
Physician global
OR: 95
SYN: 80
PL: 90 |
| Interventions |
Synvisc 3 weekly injections,
Orthovisc 3 weekly injections,
Saline 3 weekly injections
All injections injections performed by 2 physicians in anterolateral approach (along the patellar tendon) with knee in 90 degrees of flexion
Concurrent therapy: aceta‐
minophen up to 4 mg/day permitted |
| Outcomes |
WOMAC pain (5‐25), WOMAC stiffness (2‐10), WOMAC physical function (17‐85), patient and physician global assessments on a 0‐100 mm VAS scale; for both the question was, "How do you grade the severity of your (or the patient's)
knee OA according to a 0‐100 scale, 100 being the worst |
| Notes |
Jadad's: 3/5
R‐1, B‐1, W‐1
Patients did not have effusion. In bilateral disease, the more painful knee was treated. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
