The Impact of Thumb Carpometacarpal Osteoarthritis on General Health

NCT ID: NCT01133197

Last Updated: 2015-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

188 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Thumb Arthritis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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controls

No hand arthritis

No interventions assigned to this group

CMC Arthritis

Patients with arthritis

No interventions assigned to this group

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rochester

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Ryan Calfee, MD

Associate Professor of Orthopaedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ryan P Calfee, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Barnes Jewish Hospital

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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09-0829

Identifier Type: -

Identifier Source: org_study_id

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