Osteoarthritis, Knee Clinical Trial
Official title:
A Randomized Clinical Trial Comparing Hyaluronic Acid (Hylan G-F 20) and Corticosteroid (Methylprednisolone Acetate) for Knee Osteoarthritis
Do differences exist between patients who receive a single intra-articular injection of corticosteroid versus patients who receive a single intra-articular injection of hyaluronic acid for the treatment of knee osteoarthritis at 1, 3 and 6 weeks, and 3 and 6 months post injection?
OBJECTIVES
Primary i. To determine if patients' VAS "pain while walking" is different at 6 weeks
post-injection in patients who receive a single injection of methylprednisolone acetate
(MPA) versus patients who receive a single injection of Hylan G-F 20 (Synvisc One™) for
treatment of knee OA.
Secondary i. To determine if differences in VAS "pain while walking" scores exist at 1 and 3
weeks, and 3 and 6 months post injection between MPA and HA patients.
ii. To determine if differences in VAS "pain at rest" scores exist at 1, 3 and 6 weeks and 3
and 6 months post injection between MPA and HA patients.
iii. To determine if differences in VAS "pain with stairs" scores exist at 1, 3 and 6 weeks
and 3 and 6 months post injection between MPA and HA patients.
iii. To determine if differences in KOOS questionnaire scores exist at 6 weeks, 3 months and
6 months post injection between MPA and HA patients.
iv. To determine if differences in WOMAC questionnaire scores exist at 6 weeks, 3 months,
and 6 months post injection between MPA and HA patients.
v. To determine if differences in adverse events exist at 1, 3 and 6 weeks, and 3, and 6
months post injection between MPA and HA patients.
vi. To track the number of patients who receive additional injections after 3 months
following their index injection.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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