| Methods |
Randomised
Controlled
Trial
Single‐blind
Parallel‐group
Open‐label
Placebo‐ controlled
Single centre |
| Participants |
Country:
Israel
Mean age: 71
(BH: 71, PL: 70)
% Female: 73
Mean disease duration: NR
Duration: 20 wk
Number randomised: 49
(BH 25, PL 24)
Inclusion:
adults of either sex
between 60‐85 y
evidence of idio‐
pathic sympto‐
matic clinical OA of the knee as per Altman criteria and radiologically verified
OA of the knee
(stages 2 to 4: Kellgren & Lawrence: BH:
2‐6, 3‐16, 4‐3,
PL: 2‐5, 3‐11,4‐7)
in good general health
no previous history of surgical treatment of joint or arthroscopy or injections to the knee in 6 mth prior to study start
Exclusion:
pts with knee OA
originating from an i‐a fracture, RA, joint infection, other inflammatory & metabolic arthritis or OA of the hip joint,
pt with significant systemic diseases
allergy or atrophy or skin conditions overlying the joint which could cause adminis‐
tration of injections to be problematic,
pt with copious joint exudates (>15 ml of aspirated synovial fluid) |
| Interventions |
BioHy 20 mg
(10 mg/ml)
5 weekly injections
Placebo: 2 ml of phosphate buffered saline
5 weekly injections
Concurrent therapy: Para‐
cetamol and
NSAIDs were permitted |
| Outcomes |
pain at rest and during activity‐‐‐‐‐
stiffness and physical function as per the MODEMS arthritic model (none=1, mild=2,moderate
=3, severe=4, extreme=5)
[looks like WOMAC]
muscle strength, stiffness, and tenderness of joint upon palpation scored on same scale,
active range of motion:
1= >135.2; 2=90 to 135;
3=45 to 90;
4= <45 |
| Notes |
Jadad's:3/5
R‐1,B‐1,W‐1
Third author is affiliated with Bio‐Technology General. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
