At a glance
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A Study of Hyaluronan (Synvisc) for the Treatment of Osteoarthritis in the Thumb: Randomized Control Trial
In Brief
A Phase 3 clinical trial evaluating Synvisc (Hylan G-F20; hyaluronan injection), Bupivicaine (local anesthesia injection), and 1 other intervention for Osteoarthritis. Completed, enrolled 200 participants across 1 site.
Detailed Summary
Hyaluronan is a man-made preparation of a protein complex that occurs naturally in joints and that is often low in people with osteoarthritis. Although hyaluronan has been used in millions of people with knee osteoarthritis, it is not yet FDA approved for use in the thumb. The purpose of this study is to determine the safety and effectiveness of hyaluronan in relieving arthritis symptoms at the base of the thumb and to compare it to corticosteroids and local anesthetic. The principle hypothesis is that treating osteoarthritis at the carpometacarpophalangeal (CMC) joint with injectable hyaluronan will results in greater pain relief, higher patient satisfaction, and better functional outcomes than treating with placebo injections (local anesthetic) or with corticosteroid injections. Treating CMC osteoarthritis with corticosteroid injections will result in greater pain relief, higher patient satisfaction, and better functional outcomes than treating with placebo injections. Patients with worse pre-treatment function will have less improvement and worse post-treatment results after administration of corticosteroid or hyaluronan.
Study Details
Timeline
Interventions
1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks
1 ml of bupivicaine 0.5% injected once a week for 2 weeks
1 ml (40mg) of triamcinolone (Kenalog) injected the first week, followed by a placebo injection of 1 ml 0.5% bupivacaine the second week; Kenalog is a non-suspension steroid preparation and is less likely to cause post-injection flares than a suspension preparation