| Methods |
Randomised
Controlled
Trial
Single‐blind
Single centre
7‐day washout of NSAID |
| Participants |
Country: Turkey
Mean age: 58.03
% Female: 97.5
Mean disease duration: NR
Duration: 1 y
Number randomised: 47
(HA: 24, HA+TA: 23)
Inclusion:
OA of the knee according to ACR criteria,
Kellgren‐Lawrence grades II or III radiographically confirmed,
pain in affected knee for at least 6 mth
Exclusion:
received intra‐
articular injection in the joint and/or attend physiotherapy for the affected knee within 6 mth prior to study,
history of allergy or hypersensitive to drugs or eggs,
ascertained or suspected to be pregnant or lactacting,
known or suspected joint infection or a specific condition (neoplasms, diabetes mellitus, paresis, osteonecrosis, recent trauma) or poor general health that would interfere with the functional assessments during the study
Baseline values:
range of motion
HA: 112.0
HA+TA: 118.8
50‐foot walking time
HA: 23.7
HA+TA: 22.6
pain (VAS)
HA: 66.7
HA+TA: 72.6
WOMAC pain
HA: 14.3
HA+TA: 16.3
WOMAC stiffness
HA: 4.1
HA+TA: 4.1
WOMAC function
HA: 53.3
HA+TA: 49.0
WOMAC total
HA: 71.8
HA+TA: 69.6 |
| Interventions |
Orthovisc (2 ml Biomeks) alone 3 weekly injections
(Days 0,7,14) then 3 injections at month 6,
Combined group: same as above but prior to lst and 4th HA injection, effusions aspirated and then 1 ml triamcinolone acetonid (Kenacort‐A, Bristol Myers Squibb)
Concurrent therapy: paracetamol to a maximum of 2 g daily as considered appropriate by the physician was permitted;
NSAID not permitted. |
| Outcomes |
WOMAC OA Index (Likert),
pain (0‐100 mm VAS), ROM ‐ flexion only with a goniometer,
50 foot walking time (sec), assessment of effusion (peri‐
pheral measurement of knee),
MRI ‐ cartilage evaluated with an eight grade system by 2 independent observers |
| Notes |
Jadad's: 3/5
R‐2, B‐0, W‐1
No statistically significant differences in demographic or clinical data at baseline.
Although 47 patients enrolled, 7 in the HA+TA group were withdrawn as they did not meet inclusion criteria. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
