| Methods |
Randomised
Controlled
Trial
Parallel group
Double blind
15 day washout of NSAID |
| Participants |
Country:
Turkey
Mean age: 60.55
% Female: 81.5
Mean disease
duration: NR
Duration: 1 y
Number randomised: 92
(184 knees)
(OR 46, GF 46)
Inclusion:
primary OA of the knee as defined by ACR criteria,
all seeking treatment,
Kellgren‐
Lawrence stage III OA with joint space narrowing and sclerosis of subchondral bone
Exclusion:
any pt with radiographic appearance of pseudocysts was defined as Kellgren‐
Lawrence grade IV,
if pt could not discontinue NSAID beginning 15 days prior to the study due to presence of other diseases,
previous fracture around the knee, joint effusion, inflammatory arthritis, previous intraarticular injection or any other invasive procedure in the knee,
significant comorbidity (renal, hepatic or heart disease),
chicken or egg allergy
Baseline values:
pain at activity
OR: 4.4, GF 5.2
pain at rest
OR: 9.1, GF 8.1
pain during climbing stairs
OR: 2.1, GF 2.1
pain during transfer activities
OR: 2.5, GF 2.6
walking distance
OR: 5.4, GF 8.3
range of motion
OR: 113.0,
GF: 114.4
total HSS score
OR: 67.7,
GF: 70.1 |
| Interventions |
Orthovisc
3 weekly injections,
Hylan G‐F 20
(Synvisc) 3 weekly injections
Concurrent therapy: NSAID not permitted |
| Outcomes |
Hospital for Special Surgery Knee Score which includes pain at activity, pain at rest, pain during climbing stairs, pain during transfer activities, walking distance, and range of motion |
| Notes |
Jadad's: 5/5
R‐2, B‐2, W‐1
All radiographs (AP, lateral and Merchant) evaluated by 2 orthoopaedic surgeons and if consensus not achieved pt not included.
Statistically significant difference at baseline in walking distance. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
