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OpenTrials
Completed

NCT Number: NCT00198029

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

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.

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Key information

Conditions

Carpometacarpal Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

45 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Special Surgery

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. The Disabilities of the Arm, Shoulder and Hand Outcome Measure

    Time frame: 26 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 outcomes

  1. Visual Analog Scale for Pain

    Time frame: 26 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.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Collaborators

  • Genzyme, a Sanofi Company
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Sep 20, 2005
Registry last updated
Apr 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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