- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00776932
Chronic Knee Pain Study (JRPIT)
Disparity in Joint Replacement: Pathway to Intervention
Specific Aims: 1) To examine differences between AA and white patients with knee OA in willingness to consider knee joint replacement. 2) To examine the relationship between socio-cultural factors and patient willingness to consider joint replacement. 3) To examine how demographic, socio-cultural, and clinical factors mediate the relationship between race and patient willingness. 4) To examine the relationship between patient willingness and referral to orthopedic care for knee OA (secondary aim).
Experimental design/Methodology: A cross-sectional survey study design will be used to examine socio-cultural and clinical factors that may vary by race/ethnicity and may be determinants of willingness to consider joint replacement as a treatment option. Patients with symptomatic and radiographic knee OA from the primary care clinics will be surveyed. Only individuals with knee OA of sufficient severity that would be considered candidates for joint replacement will be included. Analytic strategies include ordinal logistic regression, path analysis, and regression trees.
Subject population: The study sample will consist of approximately 133 African American and 419 white patients with OA of the knee in a primary care setting.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburh Arthritis Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- over age 50
- chronic knee pain
- radiographic evidence of knee OA
Exclusion Criteria:
- previous joint replacement
- inflammatory arthritis
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Knee OA
Those over the age of 50 who have frequent pain in their knee that has lasted for at least six months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Compared to whites, AAs with knee OA will be less willing to consider joint replacement. Logistic regression will be used to model the categorical measure of willingness, if preliminary analyses indicate dichotomizing this measure.
Time Frame: Study Completion
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Study Completion
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: C. Kent Kwoh, MD, University of Pittsburgh
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07040263
- 1 P60 AR05473-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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