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Viscosupplementation
Hyaluronic Acid (HA) Injection for Osteoarthritis
N/A
Waitlist Available
Led By Brad J Monteleone, Physician
Research Sponsored by LifeMark Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (pre-injection), 1, 3 and 6 weeks, and 3 and 6 months post injection
Awards & highlights
Study Summary
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?
Eligible Conditions
- Osteoarthritis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (pre-injection), 1, 3 and 6 weeks, and 3 and 6 months post injection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pre-injection), 1, 3 and 6 weeks, and 3 and 6 months post injection
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The 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).
Secondary outcome measures
Pain at rest or with stairs as reported byu the patient on a VAS
Trial Design
2Treatment groups
Active Control
Group I: Hyaluronic Acid (HA) InjectionActive Control1 Intervention
Patients allocated to the HA group will receive a single IA injection Hylan G-F 20 Synvisc One™ (1 injection of 6cc's). All injections will be administered as outlined on the company label. Aspiration of the knee will not be performed.
Group II: Corticosteroid InjectionActive Control1 Intervention
Patients allocated to the corticosteroid injection will receive a 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. Aspiration of the knee will not be performed.
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Who is running the clinical trial?
LifeMark HealthLead Sponsor
1 Previous Clinical Trials
88 Total Patients Enrolled
Brad J Monteleone, PhysicianPrincipal InvestigatorUBC - Department of Family Practice
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