| Methods |
Randomised
Controlled
Trial
Single‐blind
Blinded clinical assessor
Right/left comparison
Single centre
Stratified on more impaired knee |
| Participants |
Country:
Germany
Mean age: 67
% Female: 53
Mean disease duration: NR
Duration: 7 wk
Number randomised: 43
(HA: 24 knees most impaired, 19 knees less impaired;
No treatment: 19 knees most impaired; 24 knees less impaired)
Inclusion:
Adults of both genders with a minimum age of 50 yr
OA of both knees
Radiographic changes = Kell‐
gren and Lawrence stage II to III bilat‐
erally
Symptomatic gonarthrosis for a minimum of 12 months
Pain during wt bearing >=4/10 cm VAS bilaterally
Lequesene score not different by more than +/‐ 2 points in total value
Exclusion:
Pts who do not meet all inclusion criteria
Neurological deficits in lower extremities
Underlying diseases such as: primary
inflammatory joint disease, joint infections, crystalline arthritis, ia tumors, axis deviation of >15o varus or valgus malalignment, ligamentous instability, previous fractures of the joint, arthroscop‐
ic surgery on the knee in the previous 12 mths
IA injections of the knee joint in 3 mth prior to study
Baseline values:
Pain at rest
HA: 3.83
NT: 3.67
Pain wt bearing
HA: 7.57
NT: 7.43
Lequesne
HA: 13.57
NT: 12.48 |
| Interventions |
Hyalart 20 mg
5 weekly injections
No treatment
Concurrent therapy: NSAID & analgesics to be avoided.
Paracetamol 500 mg was permitted as pain medication. |
| Outcomes |
Lequesne (max score 26),
pain (10 cm VAS)
isokinetic test (maximum peak torque for extensors and
flexors), total work |
| Notes |
Jadad's:1/5
R‐1,B‐0,W‐0
Baseline difference between groups in initial values for total work of the knee flexor and extensor. This may be possibly due to the fact that the more impaired knee was entered in the treatment group more often than in the control group. This trial was piloted by the trial by Schneider (1997). |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
