Chronic Knee Pain Study

Knee Osteoarthritis Clinical Trial

— JRPIT  

Official title:

Disparity in Joint Replacement: Pathway to Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00776932
• Other study ID #: 07040263
• Secondary ID: 1 P60 AR05473-01
• Status: Completed
• Phase: N/A
• First received: October 21, 2008
• Last updated: May 26, 2015
• Start date: June 2007
• Est. completion date: June 2013

Study information

• Verified date: May 2015
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 852
• Est. completion date: June 2013
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• over age 50

• chronic knee pain

• radiographic evidence of knee OA

Exclusion Criteria:

• previous joint replacement

• inflammatory arthritis

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis, Knee

Locations

Country	Name	City	State
United States	University of Pittsburh Arthritis Research Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Study Completion	No