Trial record 1 of 13 for:    Open Studies | "Thumb"
Previous Study | Return to List | Next Study

The Impact of Thumb Carpometacarpal Osteoarthritis on General Health

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Washington University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Rochester
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01133197
First received: May 26, 2010
Last updated: March 14, 2011
Last verified: March 2011
  Purpose

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
Thumb Arthritis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Impact of Thumb Carpometacarpal Osteoarthritis on General Health

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Hand Function [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Use of hand by Michigan Hand Questionnaire


Secondary Outcome Measures:
  • Overall Health [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    SF-36


Estimated Enrollment: 350
Study Start Date: July 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
controls
No hand arthritis
CMC Arthritis
Patients with 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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).
  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: NCT01133197

Locations
United States, Missouri
Barnes Jewish Hospital Recruiting
St Louis, Missouri, United States, 63110
Contact: Ryan P Calfee, MD    314-747-4705    calfeer@wudosis.wustl.edu   
Principal Investigator: Ryan P Calfee, MD         
Sponsors and Collaborators
Washington University School of Medicine
University of Rochester
Investigators
Principal Investigator: Ryan P Calfee, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Ryan P. Calfee, MD, Washington University Orthopedics
ClinicalTrials.gov Identifier: NCT01133197     History of Changes
Other Study ID Numbers: 09-0829
Study First Received: May 26, 2010
Last Updated: March 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on September 22, 2014