| Methods |
Randomised
Controlled
Trial
Single‐blind
Blinded assessor
Parallel‐group
Single centre |
| Participants |
Country:
USA
Mean age: 65
% Female: 54
Disease duration: NR
Duration: 6 mth
Number randomised: 100
(HA 50, CS 50)
Inclusion:
>18 y
x‐ray evidence of symptomatic OA of the knee
dissatisfaction with prior attempts at non‐
operative management modalities (e.g.
NSAID, oral
analgesics, nutritional supplements, PT, braces)
symptomatic=
pain with weight
bearing at TB and/or PF with one or more of:
loss of cartilage thickness, osteo‐
phyte formation, subchondral sclerosis, cysts
Exclusion:
pregnant
lactating
x‐ray signs of bone‐on‐bone
arthritis, chrondrocalcin‐
osis,
physical exam showed an insufficiency of collateral ligament or insufficiency of anterior or posterior cruciate ligament with concomitant symtomatic giving‐way of the affected extremity, or current infection in affected extremity
history of crystalline arthropathy or inflammatory arthritis, neuropathic arthropathy, an ia injection with any
corticosteroid or any HA within the previous 3 mth
allergy or hyper‐
sensitivity to study medications, eggs, feathers, avian proteins, or chickens |
| Interventions |
Hylan G‐F 20
3 weekly injections (with effusion aspiration)
Betamethasone sodium phos‐
phate‐betameth‐
asone acetate 2 ml mixed in 4 ml of Marcaine (bupivacaine) and 4 ml of lido‐
caine (effusion not aspirated) & could have 2nd injection at any time (48%)
(Celestone
Soluspan)
Concurrent therapy: NSAID permitted but tracked (HA ‐ 64%, CS ‐56% usage) |
| Outcomes |
Modified Knee Society clinical rating scale (100 points),
WOMAC OA Index (Likert),
pain (100 mm VAS) |
| Notes |
Jadad's:3/5
R‐2,B‐0,W‐1
Study was independently funded. Base‐
line significant
difference in x‐ray severity: more moderate in HA; more mild or severe in CS.
If bilateral, only one knee analysed. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
