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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00198029
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : June 10, 2013
Last Update Posted : April 17, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Carpometacarpal Osteoarthritis Device: Synvisc (hylan G-F20)

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study
Study Start Date : October 2004
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Pilot Study of Hylan G-F 20
32 Subjects have received Synvisc Injections and followed for 6 months.
Device: Synvisc (hylan G-F20)
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

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00198029

United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Genzyme, a Sanofi Company
National Institutes of Health (NIH)
Principal Investigator: Lisa Mandl, MD MPH Hospital for Special Surgery, New York
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT00198029     History of Changes
Other Study ID Numbers: 23034
Grant# K23AR050607-01
First Posted: September 20, 2005    Key Record Dates
Results First Posted: June 10, 2013
Last Update Posted: April 17, 2017
Last Verified: March 2017

Keywords provided by Hospital for Special Surgery, New York:

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Protective Agents
Physiological Effects of Drugs