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The Impact of Thumb Carpometacarpal Osteoarthritis on General Health

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ClinicalTrials.gov Identifier: NCT01133197
Recruitment Status : Completed
First Posted : May 28, 2010
Last Update Posted : June 29, 2015
Sponsor:
Collaborator:
University of Rochester
Information provided by (Responsible Party):
Ryan Calfee, MD, Washington University School of Medicine

Brief Summary:
This study is designed to define the impact of thumb arthritis on patient's general health. As a secondary objective, data will be analyzed to determine the effects of medical and musculoskeletal comorbidities on the rating of upper extremity function by the patient.

Condition or disease
Thumb Arthritis

Detailed Description:

This study is designed to define the impact of thumb arthritis on patient's general health. As a secondary objective, data will be analyzed to determine the effects of medical and musculoskeletal comorbidities on the rating of upper extremity function by the patient.

Potential Contribution: The data that we intend to gather could further our understanding of the overall health impact of thumb osteoarthritis and allow surgeons to more accurately interpret patient-rated measures of upper extremity function in the presence of comorbidities.

Osteoarthritis of the thumb carpometacarpal joint is one of the most common sites of arthritic degeneration in the hand. To date, no study has examined this conditions impact on overall health using a validated health measure (e.g. SF-36). Additionally, no study has examined the impact of medical and musculoskeletal comorbidities on patient-rated measures of upper extremity function in these patients.


Study Type : Observational
Actual Enrollment : 188 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Impact of Thumb Carpometacarpal Osteoarthritis on General Health
Study Start Date : July 2009
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
controls
No hand arthritis
CMC Arthritis
Patients with arthritis



Primary Outcome Measures :
  1. Hand Function [ Time Frame: Baseline ]
    Use of hand by Michigan Hand Questionnaire


Secondary Outcome Measures :
  1. Overall Health [ Time Frame: Baseline ]
    SF-36



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients presenting for treatment have thumb arthritis
Criteria

Inclusion Criteria:

  • Healthy adults clinically diagnosed with thumb carpometacarpal osteoarthritis. The diagnosis must have been confirmed radiographically prior to consideration for study enrollment.
  • Adults accompanying patients to participating offices will be recruited to be control subjects. They must not be receiving medical or surgical treatment for a hand or wrist complaint.
  • Additionally control subjects must not have been diagnosed with thumb osteoarthritis.

Exclusion Criteria:

  • Subjects must be over 18 years of age and English speaking.
  • Subjects are not to include incarcerated adults or those unable to provide consent for study participation.
  • Patients diagnosed with currently symptomatic hand or wrist pathology outside of the thumb carpometacarpal joint will be excluded.
  • Patient with prior surgery on the affected thumb will be excluded.
  • Pregnant females are excluded from study participation with pregnancy determined by patient self-reporting (standard of care before office radiographs).

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): NCT01133197


Locations
United States, Missouri
Barnes Jewish Hospital
St Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
University of Rochester
Investigators
Principal Investigator: Ryan P Calfee, MD Washington University School of Medicine

Responsible Party: Ryan Calfee, MD, Associate Professor of Orthopaedic Surgery, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01133197     History of Changes
Other Study ID Numbers: 09-0829
First Posted: May 28, 2010    Key Record Dates
Last Update Posted: June 29, 2015
Last Verified: June 2015

Keywords provided by Ryan Calfee, MD, Washington University School of Medicine:
thumb
arthritis
Impact of thumb arthritis on health

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