CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 200 enrolled
Drug / intervention
Synvisc (Hylan G-F20; hyaluronan injection) +2 moredrug
Likely dose
Synvisc (Hylan G-F20; hyaluronan injection) 1 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00398866
NCT00398866Phase 3Completed

A Study of Hyaluronan (Synvisc) for the Treatment of Osteoarthritis in the Thumb: Randomized Control Trial

Hospital for Special Surgery, New York·interventional·Posted Nov 14, 2006·Updated Jul 7, 2017

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis
CountriesUnited States

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 14, 2006
Enrollment StartAug 1, 2006
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 19.6 years ago

Interventions

Synvisc (Hylan G-F20; hyaluronan injection)drug

1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks

Bupivicaine (local anesthesia injection)drug

1 ml of bupivicaine 0.5% injected once a week for 2 weeks

Kenalog (triamcinolone; corticosteroid injection)drug

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