| Methods |
Randomised
Controlled
Trial
Single centre |
| Participants |
Country:
Brazil
Mean age: 54.5
% Female: 80
Mean disease duration: NR
Duration: 6 mth
Number randomised: 20
(HA 10, AR 10)
Inclusion:
knee arthrosis refractory to conservative treatment with blockage and pain symptoms,
grade 3 Kellgren and Lawrence radiological classification
Exclusion:
NR
Baseline values (preoperative):
Pain in rest
HA 7.90
AR 8.30
Pain with load
HA 8.60
AR 9.20
Pain upon movement
HA 8.40
AR 9.10
Diclofenac used
HA 2.80
AR 2.50
Postoperative values:
Pain in rest
HA 3.20
AR 4.00
Pain with load
HA 3.80
AR 4.50
Pain upon movement
HA 3.90
AR 5.20
Diclofenac usage
HA 0.90
AR 0.80 |
| Interventions |
Arthroscopy (articular lavage and debridement) plus 3 weekly injections of hylan G‐F 20,
Arthroscopy alone
Both groups instructed to stroll first postoperative day. Stitches removed at first visit after 2 weeks at which time the course of Hylan G‐F 20 was started.
Concurrent therapy: potassium diclofenac permitted with daily usage recorded. |
| Outcomes |
VAS (patient saw "faces" and colours ranging from blue to red as pain increased while observer side showed absolute numerical value (0‐10)
pain during the night,
pain during movement with a 10% overload of weight on affected knee, pain reduction during the most painful movements of the knee, daily amount of potassium diclofenac used to relieve pain of the injured knee, chondral lesions at time of arthroscopy scored by Noyes and Stabler appud Lemark (grades I to III) |
| Notes |
Jadad's: 2/5
R‐1, B‐0, W‐1
No between group differences at baseline. Statistical analyses completed at Laboratory for Study Design and Data Analyses of the Dept. of Epidemiology and Public Health of the Medical School of Sao Jose do rio Preto. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
