A Study of Hyaluronan for the Treatment of Osteoarthritis in the Thumb
Status:
Completed
Trial end date:
2013-03-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Hospital for Special Surgery, New York
Collaborators:
Genzyme, a Sanofi Company National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)