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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
78
Single IA injection of 6cc's. Injections will be administered as outlined on the company label.
Single IA injection of 80mg of methylprednisolone acetate (1cc of solution) mixed with 5cc's of 1% lidocaine without epinephrine for a total of 6cc's. The injection will be administered as outlined on the company label.
LifeMark Health
Kelowna, British Columbia, Canada
The primary outcome will be "pain while walking for approximately 30 minutes on a flat surface today" as reported by the patient on a 100mm unmarked VAS (0 = no pain; 100 = worst pain possible).
As described in title
Time frame: VAS Form will be given at baseline (prior to injection) and then at 1, 3 and 6 weeks, and 3 and 6 months post injection.
Pain at rest or with stairs as reported byu the patient on a VAS
Secondary Outcomes: i. "Pain at rest" and "pain with stairs" as reported by the patient on a VAS (Additional outcomes ii. Knee injury and Osteoarthritis Outcome Score (KOOS). The KOOS is a valid, reliable and responsive questionnaire that is self-administered and consists of 5 subscales. iii. The KOOS includes the WOMAC Osteoarthritis Index LK 3.0 and thus, WOMAC scores will also be computed. iv. Adverse events as reviewed and documented by the physician v. The number of subsequent re-injections or treatment strategies.)
Time frame: Baseline (pre-injection), 1, 3 and 6 weeks, and 3 and 6 months post injection
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