Clinical trial NCT01133197: The Impact of Thumb Carpometacarpal Osteoarthritis on General Health
Official title: The Impact of Thumb Carpometacarpal Osteoarthritis on General Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thumb Arthritis
Keywords: thumb
arthritis
Impact of thumb arthritis on health
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Rochester
First posted: 2010-05-28
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients presenting for treatment have thumb arthritis

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.

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 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).

Primary outcomes:
measure: Hand Function
timeFrame: Baseline
Secondary outcomes:
measure: Overall Health
timeFrame: Baseline
Other outcomes:
Locations:
city: St Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Ryan P Calfee, MD
role: PRINCIPAL_INVESTIGATOR
References: