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

All Individual Drugs Already Approved

Approved for 50 Other Conditions

No Placebo-Only Group

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (pre-injection), 1, 3 and 6 weeks, and 3 and 6 months post injection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Pain at rest or with stairs as reported byu the patient on a VAS

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 50 Other Conditions

This treatment demonstrated efficacy for 50 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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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