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

This study has been completed.
Sponsor:
Collaborators:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Dr. Lisa Mandl, Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT00198029
First received: September 13, 2005
Last updated: May 3, 2013
Last verified: May 2013
  Purpose

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 Intervention
Carpometacarpal Osteoarthritis
Device: Synvisc (hylan G-F20)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: An Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study

Resource links provided by NLM:


Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome Measures:
  • The Disabilities of the Arm, Shoulder and Hand Outcome Measure [ Time Frame: 26 weeks (6 months) ] [ Designated as safety issue: No ]
    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:
  • Visual Analog Scale for Pain [ Time Frame: 26 weeks (6 months) ] [ Designated as safety issue: No ]
    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.


Enrollment: 32
Study Start Date: October 2004
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   45 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00198029

Locations
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
Investigators
Principal Investigator: Lisa Mandl, MD MPH Hospital for Special Surgery, New York
  More Information

No publications provided by Hospital for Special Surgery, New York

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Lisa Mandl, Lisa Mandl, MD MPH, Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT00198029     History of Changes
Other Study ID Numbers: 23034, 101584, Grant# K23AR050607-01
Study First Received: September 13, 2005
Results First Received: January 31, 2013
Last Updated: May 3, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Hospital for Special Surgery, New York:
Osteoarthritis
Hyaluronan
Carpometacarpal
Outcomes

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 23, 2014