Knee OsteoarthritisJRPITNCT00776932
Chronic Knee Pain Study
An observational study of Knee Osteoarthritis, run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- How many people
- 852 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: African Americans and Whites over the age of 50 with chronic knee pain.
Who may be able to join
- over age 50
- chronic knee pain
- radiographic evidence of knee OA
Who cannot join
- previous joint replacement
- inflammatory arthritis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburh Arthritis Research Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: 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.
- Conditions
- Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Knee OA | Those over the age of 50 who have frequent pain in their knee that has lasted for at least six months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Study Completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2008 (estimated)
- Study startJun 2007
- Primary completionAug 2011
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 852 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- C. Kent Kwoh, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776932
- Sponsor's protocol ID
- 07040263
- Other IDs
- 1 P60 AR05473-01
- Acronym
- JRPIT
- Status last verified
- May 2015
- First submitted
- 21 Oct 2008
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disparity in Joint Replacement: Pathway to Intervention
- ClinicalTrials.gov ID
- NCT00776932
- Acronym / sponsor ID
- JRPIT / 07040263
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 852 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jun 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 22 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee OA | – | –Those over the age of 50 who have frequent pain in their knee that has lasted for at least six months. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- African Americans and Whites over the age of 50 with chronic knee pain.
Key inclusion criteria (3 listed)
- over age 50
- chronic knee pain
- radiographic evidence of knee OA
Key exclusion criteria (2 listed)
- previous joint replacement
- inflammatory arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
Related trials for Knee Osteoarthritis
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
RecruitingPhase 2
Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
Knee Osteoarthritis, Knee Osteoarthritis (Knee OA)
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
The Effect of Different Exercise Training Programs on Muscle Oxygenation in Individuals With Knee Osteoarthritis
Osteoarthritis of Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
C. Kent Kwoh, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.