Knee Osteoarthritis Clinical Trial
Official title:
Examining Stated-Preferences in Knee Arthroplasty: Unicompartmental Knee Arthroplasty (UKA) or Total Knee Arthroplasty (TKA)
NCT number | NCT03058380 |
Other study ID # | Pro00079625 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 17, 2017 |
Est. completion date | June 1, 2018 |
Verified date | May 2019 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The primary objectives of this study are to apply best-practice stated-preference methods to quantify patient preferences for benefit-risk tradeoffs associated with arthroplasty treatment options for end-stage osteoarthritis of the knee. Duke will develop and administer stated-preference surveys to adult patients (Ages 40-80) with knee pain to collect preference data, estimate the relative importance of treatment features and outcomes, and estimate maximum acceptable risks for given benefits and minimum acceptable benefits for given harms. This study proposal describes plans for the patient stated-preference survey.
Status | Completed |
Enrollment | 348 |
Est. completion date | June 1, 2018 |
Est. primary completion date | June 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Age 40-80 - Knee Pain Exclusion Criteria: - Inability to read, understand and give effective English consent |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Health System | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | Duke Clinical Research Institute, Zimmer Biomet |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient Preference Measurements | Patient-stated preferences regarding treatment for knee pain based on questionnaires | 20 minutes |
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