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An Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study

Hospital for Special Surgery (HSS) logo

Hospital for Special Surgery (HSS)

Status

Completed

Conditions

Carpometacarpal Osteoarthritis

Treatments

Device: Synvisc (hylan G-F20)

Study type

Interventional

Funder types

Other
Industry
NIH

Identifiers

NCT00198029
23034
101584
Grant# K23AR050607-01

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

45 to 95 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Radiographic evidence of at least moderate narrowing (joint space < 1mm) or the presence of osteophytes or sclerosis at the Carpometacarpal joint
  • Patient complaint of unacceptable pain despite modification of activity, a trial of splinting and a therapeutic dose of NSAIDS
  • If bilateral disease, only the most severely involved hand, (as defined by VAS for pain), will be entered in the study.
  • Proficiency in English.

Exclusion criteria

  • Previous bad injury to the thumb
  • Previous hand surgery on the study thumb
  • Known hand comorbidities (i.e. carpal tunnel syndrome, de Quervains Tenosynovitis etc)
  • Rheumatoid arthritis or lupus
  • Bleeding problems
  • Being on blood thinners (except aspirin)
  • Known allergies to any of the medications being used
  • Allergies to chicken products
  • Current use of oral steroids
  • Cancer that is not cured or in remission
  • Severe diabetes
  • A serious infection somewhere else in the subject's body

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

32 participants in 1 patient group

Pilot Study of Hylan G-F 20
Experimental group
Description:
32 Subjects have received Synvisc Injections and followed for 6 months.
Treatment:
Device: Synvisc (hylan G-F20)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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