| Methods |
Randomised
Controlled
Trial
Parallel‐group
Double‐blind
Multicentre (n=10) |
| Participants |
Country:
Germany
Mean age: 63.2
% Female: 64.5
Mean disease duration: 58.9 mth
Duration: 12 wk
Number randomised: 321
(EUF 160, SYN 161)
Inclusion:
either sex,
age 50 to 80 y,
confirmed OA in one or both knees,
clinical evidence of chronic idiopathic OA of the study knee according to criteria of Altman, radiologically verified OA of the study knee by modified Kellgren‐Lawrence (grade 2 or 3),
symptoms in study knee for at least 1 y,
willingness to discontinue all OA treatments other than acetaminophen, moderate to severe knee pain as reflected by a VAS pain score of 41 to 80 out of 100 mm for the average of the WOMAC OA Index pain subscale with only one pain item permitted to be below 20 mm or above 80 mm
Exclusion:
secondary OA originating from a known injury to the knee, RA,
history of joint infection, dermatologic disorders or skin infection in proximity to study knee, osteonecrosis, chronic active fibromyalgia, any inflammatory or metabolic arthrides and known sensitivity to acetaminophen or hyaluronan,
hyaluronan injection to study knee within 6 mth of screening, corticosteroid injection and surgery or arthroscopy to study knee within 3 mth of screening, nonambulatory patients: inability to perform a 50 foot walk test, patients with symptomatic OA of the hip or any other health condition that would have interfered with study assessments including patients with uncontrolled hematological, cardiovascular, neoplastic, pulmonary, neurological, renal, hepatic or systemic disease,
clinical lab values: fasting blood glucose concentration greater than 160mg/dl, alkaline phosphatase greater than 250 U/I, alanine aminotransferase greater than 30 U/I, or aspartate aminotransferase greater than 30 U/I,
participation in another study during the study period and during the 4 wk prior to study enrollment
Baseline values:
WOMAC pain
EUF 49.2
SYN 51.9
WOMAC stiffness
EUF 43.2
SYN 47.8
WOMAC function
EUF 47.0
SYN 50.8
WOMAC total
EUF 47.2
SYN 50.8 |
| Interventions |
Euflexxa (bioengineered 1% sodium hyaluronate)
(20 mg/2 ml)
3 weekly injections,
Synvisc
(16 mg/2 ml)
3 weekly injections
Both groups advised to rest for 24 h following each injection. Before each injection, any SF that was present was aspirated.
Concurrent therapy:
acetaminophen (500 mg tablets) up to 4 g daily was permitted as rescue medication;
NSAIDs and other non‐acetaminophen pain medications were prohibited |
| Outcomes |
WOMAC OA Index pain subscale‐‐‐‐‐‐‐‐‐‐‐
WOMAC stiffness,
WOMAC physical function,
patient global assessment of treatment, "Are you satisfied with the results of the injections?" with response graded on a 4‐point ordinal scale: 1=dissatisfied, 2=slightly satisfied, 3=satisfied,
4=very satisfied;
patient consumption of acetaminophen for pain relief as quantified by pill counts |
| Notes |
Jadad's: 5/5
R‐2, B‐2, W‐1
Study supported by Ferring Pharmaceuticals, Inc.
Statistical review by W. Huang, PhD, Savient Pharmaceuticals, clinical and regulatory support by R. Zaibel, Bio‐Technology General (Israel) Ltd., editorial assistance in manuscript preparation provided by BioScience Communications, New York |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
