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

Not Applicable
Completed
Conditions
Carpometacarpal Osteoarthritis
Interventions
Device: Synvisc (hylan G-F20)
Registration Number
NCT00198029
Lead Sponsor
Hospital for Special Surgery, New York
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
32
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Pilot Study of Hylan G-F 20Synvisc (hylan G-F20)32 Subjects have received Synvisc Injections and followed for 6 months.
Primary Outcome Measures
NameTimeMethod
The Disabilities of the Arm, Shoulder and Hand Outcome Measure26 weeks (6 months)

The DASH Outcome Measure is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. Scores are transformed to a 0-100 scale, with a higher value indicating greater disability. The change in DASH (delta) over those 6 months was recorded.

Secondary Outcome Measures
NameTimeMethod
Visual Analog Scale for Pain26 weeks (6 months)

The visual analog scale for pain (VAS) is a test requiring a patient to indicate along a line how much pain they are experiencing between 0-100. A score of 100 indicates the maximum possible pain level and a score of 0 indicates no pain. Scores are recorded as whole number integers. The change in VAS (delta) over those 6 months was recorded.

Trial Locations

Locations (1)

Hospital for Special Surgery

🇺🇸

New York, New York, United States

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