The Impact of Thumb Carpometacarpal Osteoarthritis on General Health

Completed

• Conditions: Thumb Arthritis

• Registration Number: NCT01133197
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-07
• Study First Submitted: 2010-05-26
• Study First Submitted QC: 2010-05-27
• Study First Posted: 2010-05-28
• Status Verified: 2015-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Last Update Submitted: 2015-06-26
• Last Update Posted: 2015-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hand Function	Baseline	Use of hand by Michigan Hand Questionnaire

Secondary Outcome Measures

Name	Time	Method
Overall Health	Baseline	SF-36

Trial Locations

Locations (1)

Barnes Jewish Hospital; 🇺🇸 St Louis, Missouri, United States