| Methods |
Randomised
Controlled
Trial
Double blind
Multicentre (n=18)
1 wk washout NSAID |
| Participants |
Country:
Canada (6 sites),
Sweden (5 sites),
United States (7 sites)
Mean age: 63.1
% Female: 55
Mean disease
duration: 5.75 y
Duration: 26 wk
Number randomised: 347
(HA 173, PL 174)
Inclusion:
OA of the knee as defined by the ACR criteria that was refractory to non‐pharmacologic therapies,
a WOMAC pain subscale score greater than or equal to 7 in one knee and no greater than 15 in either knee (range 0 to 20 Likert scale),
significant knee pain in the signal knee for the majority of the preceding 3 mth,
pts had to be normally active and able to walk 50 m unaided
Exclusion:
Isolated patello‐
femoral OA, use of systemic steroids, glucosamine or chondroitin within the past 3 mth,
intra‐articular injection into the knee of corticosteroids in the past 3 mth or intra‐articular HA within the last 9 mth,
treatment with oral or topical NSAIDs during the previous wk,
use of topical non‐NSAIDs within the previous 3 days,
arthroscopy or other surgical procedure within the last 12 mth and anticoagulant treatment (except acetylsalicyclic acid less than or equal to 325 mg per day),
presented with a systemic active inflammatory condition or infection,
septic knee arthritis within the previous 3 month,
significant venous or lymphatic stasis of the legs, active skin disease or infection at the injectione site, or any other medical condition rendering the pt unsuitble for inclusion according to the investigator, pregnant or breast‐feeding women and those of childbearing potential not practicicing adequate contraception
Baseline values:
WOMAC pain:
HA: 9.90, PL 10.42
WOMAC stiffness
HA: 3.91, PL 4.30
WOMAC function
HA: 30.70
PL: 32.16
Pt global
HA: 3.23
PL: 3.17
SF‐36 physical component summary
HA: 33.54,
PL: 32.91
SF‐36 mental component summary
HA: 55.55,
PL: 55.92 |
| Interventions |
NASHA (non‐animal stabilized hyaluronic acid) Durolane, a single 3 ml injection containing HA 60 mg in buffered sodium chloride 0.9% (pH 7),
Placebo: saline, identifical buffered sodium chloride vehicle
Both NASHA and saline supplied in identical 3 ml syringes; an 18‐22 G needle
Concurrent therapy: acetaminophen (paracetamol maximum daily dose 4 g) was permitted as rescue medication except during the 48 h period prior to each study visit |
| Outcomes |
Responder (positive response to treatment) was defined as a reduction in the WOMAC pain score of at least 40% with an absolute improvement of at least 5 points compared with baseline for the study knee at the final visit‐‐‐‐‐‐‐‐‐‐‐‐
WOMAC stiffness, WOMC physical function score,
pt assessment of global disease status ona 5‐point scale,
SF‐36 |
| Notes |
Jadad's: 5/5
R‐2, B‐2, W‐1
This study was supported by Q‐Med AB, Uppsala, Sweden.
Formal statistical comparison of groups at baseline not completed, but authors noted there was a trend towards higher WOMAC pain, stiffness and function scores in PL group and also more females than males in the PL group, and also higher incidence of joint effusion in PL group. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
