CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 32 enrolled
Drug / intervention
Synvisc (hylan G-F20)device
Likely dose
Synvisc (hylan G-F20) 3 × 1 mL intraarticular injections over 3 weeksAI-extracted
Key inclusion· 4
  • ✓Radiographic evidence of at least moderate CMC joint narrowing (joint space <1mm) or osteophytes/sclerosis
  • ✓Unacceptable pain despite activity modification, splinting trial, and therapeutic-dose NSAIDs
  • ✓If bilateral disease, only the most severely involved hand (by pain) enrolled
  • ✓Proficiency in English
Key exclusion· 10
  • ✕Previous significant thumb injury
  • ✕Prior hand surgery on the study thumb
  • ✕Known hand comorbidities (carpal tunnel syndrome, de Quervain's tenosynovitis, etc.)
  • ✕Rheumatoid arthritis or lupus

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

Search/NCT00198029
NCT00198029N/ACompleted
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An Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study

Hospital for Special Surgery, New York·interventional·Posted Sep 20, 2005·Updated Apr 17, 2017

In Brief

A clinical study evaluating Synvisc (hylan G-F20) for Carpometacarpal Osteoarthritis. Completed, enrolled 32 participants across 1 site.

Detailed Summary

The purpose of this study is to find out if hyaluronan, an injectable medication for knee arthritis, also works for arthritis at the base of the thumb. This study will also evaluate how good ultrasound is at visualizing medication in the thumb joint. We are no longer recruiting for this part of the open label trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarpometacarpal Osteoarthritis
CountriesUnited States
CollaboratorsGenzyme, a Sanofi Company, National Institutes of Health (NIH)

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2005
Enrollment StartOct 1, 2004
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 20.8 years ago

Interventions

Synvisc (hylan G-F20)device

32 subjects in the pilot study have received 3 1ml injections of Synvisc intraarticular over the course of 3 weeks and then followed for 6 months post injection